Ignite Creation Date:
2025-12-25 @ 2:43 AM
Ignite Modification Date:
2026-02-21 @ 11:17 PM
Study NCT ID:
NCT04410133
Status:
COMPLETED
Last Update Posted:
2025-08-28
First Post:
2020-05-27
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study to Establish the Diagnostic Performance of 18F Fluciclovine PET in Detecting Recurrent Brain Metastases
Sponsor:
Organization:
Raw JSON
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Specifically, subjects had to be planned for further confirmatory diagnostic procedures to confirm the brain MRI findings: either biopsy/neurosurgical intervention, or clinical follow-up, as SoC.', 'otherNumAtRisk': 151, 'deathsNumAtRisk': 151, 'otherNumAffected': 15, 'seriousNumAtRisk': 151, 'deathsNumAffected': 0, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Infusion site bruising', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Injection site reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Paraesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Seizure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hordeolum', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Metastases to central nervous system', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Insomnia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Seizure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Metastases to central nervous system', 'stats': [{'groupId': 'EG000', 'numAtRisk': 151, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Positive Percent Agreement (PPA) and Negative Percent Agreement (NPA) Subject Level', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '41', 'groupId': 'OG002'}, {'value': '109', 'groupId': 'OG003'}, {'value': '110', 'groupId': 'OG004'}, {'value': '110', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Reader 1 - 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At the participant level, if the reference lesion is indeterminate, then the worst case is used to impute the indeterminate finding into positive or negative. However, at the lesion level, lesions with indeterminate findings are excluded i.e. only lesions with positive or negative finding are included in the analysis.'}, {'type': 'SECONDARY', 'title': 'Lesion-level Positive Predictive Value (PPV) and Negative Predictive Value (NPV)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}, {'value': '47', 'groupId': 'OG002'}, {'value': '122', 'groupId': 'OG003'}, {'value': '105', 'groupId': 'OG004'}, {'value': '104', 'groupId': 'OG005'}]}, {'units': 'Lesions', 'counts': [{'value': '31', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}, {'value': '156', 'groupId': 'OG003'}, {'value': '138', 'groupId': 'OG004'}, {'value': '135', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Reader 1 - Positive Predictive Value (PPV)', 'description': 'Only Lesions with a positive finding by BIE are included in the denominator for reach reader'}, {'id': 'OG001', 'title': 'Reader 2 - 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Concurrent Immunotherapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '46', 'groupId': 'OG001'}, {'value': '47', 'groupId': 'OG002'}, {'value': '122', 'groupId': 'OG003'}, {'value': '105', 'groupId': 'OG004'}, {'value': '104', 'groupId': 'OG005'}]}], 'groups': [{'id': 'OG000', 'title': 'Reader 1 - Positive Predictive Value (PPV)', 'description': 'Only subjects with a positive finding by BIE are included in the denominator for reach reader'}, {'id': 'OG001', 'title': 'Reader 2 - Positive Predictive Value (PPV)', 'description': 'Only subjects with a positive finding by BIE are included in the denominator for reach reader'}, {'id': 'OG002', 'title': 'Reader 3 - Positive Predictive Value (PPV)', 'description': 'Only subjects with a positive finding by BIE are included in the denominator for reach reader'}, {'id': 'OG003', 'title': 'Reader 1 - Negative Predictive Value (NPV)', 'description': 'Only subjects with a negative finding by BIE are included in the denominator for reach reader'}, {'id': 'OG004', 'title': 'Reader 2 - Negative Predictive Value (NPV)', 'description': 'Only subjects with a negative finding by BIE are included in the denominator for reach reader'}, {'id': 'OG005', 'title': 'Reader 3 - Negative Predictive Value (NPV)', 'description': 'Only subjects with a negative finding by BIE are included in the denominator for reach reader'}], 'classes': [{'title': 'Received Concurrent Immunotherapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '36', 'groupId': 'OG003'}, {'value': '31', 'groupId': 'OG004'}, {'value': '32', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '20.0', 'groupId': 'OG001', 'lowerLimit': '0.5', 'upperLimit': '71.6'}, {'value': '25.0', 'groupId': 'OG002', 'lowerLimit': '0.6', 'upperLimit': '80.6'}, {'value': '83.3', 'groupId': 'OG003', 'lowerLimit': '67.2', 'upperLimit': '93.6'}, {'value': '83.9', 'groupId': 'OG004', 'lowerLimit': '66.3', 'upperLimit': '94.6'}, {'value': '84.4', 'groupId': 'OG005', 'lowerLimit': '67.2', 'upperLimit': '94.7'}]}]}, {'title': 'Did Not Receive Concurrent Immunotherapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}, {'value': '43', 'groupId': 'OG002'}, {'value': '86', 'groupId': 'OG003'}, {'value': '74', 'groupId': 'OG004'}, {'value': '72', 'groupId': 'OG005'}]}], 'categories': [{'measurements': [{'value': '34.5', 'groupId': 'OG000', 'lowerLimit': '17.9', 'upperLimit': '54.3'}, {'value': '31.7', 'groupId': 'OG001', 'lowerLimit': '18.1', 'upperLimit': '48.1'}, {'value': '32.6', 'groupId': 'OG002', 'lowerLimit': '19.1', 'upperLimit': '48.5'}, {'value': '69.8', 'groupId': 'OG003', 'lowerLimit': '58.9', 'upperLimit': '79.2'}, {'value': '70.3', 'groupId': 'OG004', 'lowerLimit': '58.5', 'upperLimit': '80.3'}, {'value': '70.8', 'groupId': 'OG005', 'lowerLimit': '58.9', 'upperLimit': '81.0'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'MRI for anatomical correlation within 3 days of IMP and PET scan, followed by surgical intervention (if applicable) post-PET scan and follow up through 6 months after PET scan.', 'description': 'Sub-group analyses of subject-level PPV \\& NPV of fluciclovine (18F) PET, according to Concurrent Immunotherapy.', 'unitOfMeasure': 'percentage', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects with a positive or negative finding by BIE, with outcome measures categorized by concurrent Immunotherapy.'}, {'type': 'SECONDARY', 'title': 'Clinical Usefulness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Subjects Receiving Single IV Administration of 18F Fluciclovine for PET Scan', 'description': 'Subjects with a history of brain metastases previously treated with primary, adjuvant or repeat (salvage) radiation therapy, with a recent (within no more than 42 days before the study PET scan) SoC brain MRI found to be equivocal for recurrent brain metastasis, and who met all the inclusion criteria and none of the exclusion criteria, were consented and enrolled into the study. Specifically, subjects had to be planned for further confirmatory diagnostic procedures to confirm the brain MRI findings: either biopsy/neurosurgical intervention, or clinical follow-up, as SoC.'}], 'classes': [{'categories': [{'measurements': [{'value': '112', 'groupId': 'OG000', 'lowerLimit': '77.0', 'upperLimit': '142.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Follow up through 6 months after PET scan.', 'description': 'Number of days taken by the site to establish presence/absence of metastasis by clinical follow-up.', 'unitOfMeasure': 'Days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Clinical Usefulness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Subjects Receiving Single IV Administration of 18F Fluciclovine for PET Scan', 'description': 'Subjects with a history of brain metastases previously treated with primary, adjuvant or repeat (salvage) radiation therapy, with a recent (within no more than 42 days before the study PET scan) SoC brain MRI found to be equivocal for recurrent brain metastasis, and who met all the inclusion criteria and none of the exclusion criteria, were consented and enrolled into the study. Specifically, subjects had to be planned for further confirmatory diagnostic procedures to confirm the brain MRI findings: either biopsy/neurosurgical intervention, or clinical follow-up, as SoC.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.3', 'groupId': 'OG000', 'lowerLimit': '0.2', 'upperLimit': '4.7'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Follow up through 6 months after PET scan.', 'description': 'Proportion of subjects with additional metastases identified on fluciclovine (18F) PET in addition to SoC brain MRI', 'unitOfMeasure': 'percentage', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects with Additional Metastases Identified on Fluciclovine (18F) PET vs SoC MRI'}, {'type': 'SECONDARY', 'title': 'Clinical Usefulness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Subjects Receiving Single IV Administration of 18F Fluciclovine for PET Scan', 'description': 'Subjects with a history of brain metastases previously treated with primary, adjuvant or repeat (salvage) radiation therapy, with a recent (within no more than 42 days before the study PET scan) SoC brain MRI found to be equivocal for recurrent brain metastasis, and who met all the inclusion criteria and none of the exclusion criteria, were consented and enrolled into the study. Specifically, subjects had to be planned for further confirmatory diagnostic procedures to confirm the brain MRI findings: either biopsy/neurosurgical intervention, or clinical follow-up, as SoC.'}], 'classes': [{'categories': [{'measurements': [{'value': '26.5', 'groupId': 'OG000', 'lowerLimit': '19.7', 'upperLimit': '34.3'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Follow up through 6 months after PET scan.', 'description': 'Proportion of subjects whose prospective diagnostic management plan changed following fluciclovine (18F) PET.', 'unitOfMeasure': 'percentage', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects with Changes to Diagnostic Plan on Reference Lesion Following Fluciclovine (18F) PET'}, {'type': 'SECONDARY', 'title': 'Inter-reader Reproducibility', 'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Subjects Receiving Single IV Administration of 18F Fluciclovine for PET Scan', 'description': 'Subjects with a history of brain metastases previously treated with primary, adjuvant or repeat (salvage) radiation therapy, with a recent (within no more than 42 days before the study PET scan) SoC brain MRI found to be equivocal for recurrent brain metastasis, and who met all the inclusion criteria and none of the exclusion criteria, were consented and enrolled into the study. Specifically, subjects had to be planned for further confirmatory diagnostic procedures to confirm the brain MRI findings: either biopsy/neurosurgical intervention, or clinical follow-up, as SoC.'}], 'classes': [{'title': 'Reader 1 vs Reader 2', 'categories': [{'measurements': [{'value': '86.1', 'groupId': 'OG000'}]}]}, {'title': 'Reader 1 vs Reader 3', 'categories': [{'measurements': [{'value': '84.1', 'groupId': 'OG000'}]}]}, {'title': 'Reader 2 vs Reader 3', 'categories': [{'measurements': [{'value': '91.4', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'PET Scan Day 1', 'description': 'Pairwise comparisons of the central reads for the 3 readers (i.e. Reader 1 vs Reader 2, Reader 1 vs Reader 3, and Reader 2 vs Reader 3) at the subject-level. The percentage of results in agreement (i.e. Positive \\[1st reader\\] / Positive \\[2nd reader\\], Negative/Negative) is presented.', 'unitOfMeasure': 'percentage', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Intra-reader Reproducibility', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Subjects Receiving Single IV Administration of 18F Fluciclovine for PET Scan', 'description': 'Subjects with a history of brain metastases previously treated with primary, adjuvant or repeat (salvage) radiation therapy, with a recent (within no more than 42 days before the study PET scan) SoC brain MRI found to be equivocal for recurrent brain metastasis, and who met all the inclusion criteria and none of the exclusion criteria, were consented and enrolled into the study. Specifically, subjects had to be planned for further confirmatory diagnostic procedures to confirm the brain MRI findings: either biopsy/neurosurgical intervention, or clinical follow-up, as SoC.'}], 'classes': [{'title': 'Reader 1 initial read vs re-read', 'categories': [{'measurements': [{'value': '93.5', 'groupId': 'OG000'}]}]}, {'title': 'Reader 2 initial read vs re-read', 'categories': [{'measurements': [{'value': '93.5', 'groupId': 'OG000'}]}]}, {'title': 'Reader 3 initial read vs re-read', 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'PET Scan Day 1', 'description': 'Pairwise comparisons of the initial read vs re-read of a subset of PET scans for each reader at the subject-level. The percentage of results in agreement (i.e. Positive \\[initial read\\] / Positive \\[re-read\\], Negative/Negative) is presented.', 'unitOfMeasure': 'percentage', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Assess the Safety of Fluciclovine (18F) Injection in the Subject Population, Blood Pressure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Subjects Receiving Single IV Administration of 18F Fluciclovine for PET Scan', 'description': 'Subjects with a history of brain metastases previously treated with primary, adjuvant or repeat (salvage) radiation therapy, with a recent (within no more than 42 days before the study PET scan) SoC brain MRI found to be equivocal for recurrent brain metastasis, and who met all the inclusion criteria and none of the exclusion criteria, were consented and enrolled into the study. 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Specifically, subjects had to be planned for further confirmatory diagnostic procedures to confirm the brain MRI findings: either biopsy/neurosurgical intervention, or clinical follow-up, as SoC.'}], 'classes': [{'title': 'Heart Rate: Pre-IMP Injection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '144', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '76.2', 'spread': '13.53', 'groupId': 'OG000'}]}]}, {'title': 'Heart Rate: Post PET Scan', 'denoms': [{'units': 'Participants', 'counts': [{'value': '144', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '74.5', 'spread': '12.93', 'groupId': 'OG000'}]}]}, {'title': 'Heart Rate: Change from Pre to Post', 'denoms': [{'units': 'Participants', 'counts': [{'value': '144', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-1.7', 'spread': '8.43', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'The vital signs collected between 5 to 60 minutes before and after the PET scan.', 'description': 'Treatment-emergent adverse events (TEAEs) following 18F-fluciclovine injection in the subject population.', 'unitOfMeasure': 'beat/min', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Collected and Reported'}, {'type': 'SECONDARY', 'title': 'Assess the Safety of Fluciclovine (18F) Injection in the Subject Population, Respiratory Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Subjects Receiving Single IV Administration of 18F Fluciclovine for PET Scan', 'description': 'Subjects with a history of brain metastases previously treated with primary, adjuvant or repeat (salvage) radiation therapy, with a recent (within no more than 42 days before the study PET scan) SoC brain MRI found to be equivocal for recurrent brain metastasis, and who met all the inclusion criteria and none of the exclusion criteria, were consented and enrolled into the study. Specifically, subjects had to be planned for further confirmatory diagnostic procedures to confirm the brain MRI findings: either biopsy/neurosurgical intervention, or clinical follow-up, as SoC.'}], 'classes': [{'title': 'Respiratory Rate: Pre-IMP Injection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '143', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '16.7', 'spread': '2.76', 'groupId': 'OG000'}]}]}, {'title': 'Respiratory Rate: Post PET Scan', 'denoms': [{'units': 'Participants', 'counts': [{'value': '141', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '16.5', 'spread': '2.72', 'groupId': 'OG000'}]}]}, {'title': 'Respiratory Rate: Change from Pre to Post', 'denoms': [{'units': 'Participants', 'counts': [{'value': '141', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.2', 'spread': '1.85', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'The vital signs collected between 5 to 60 minutes before and after the PET scan.', 'description': 'Treatment-emergent adverse events (TEAEs) following 18F-fluciclovine injection in the subject population.', 'unitOfMeasure': 'breaths/min', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Collected and Reported'}, {'type': 'SECONDARY', 'title': 'Assess the Safety of Fluciclovine (18F) Injection in the Subject Population, Body Temperature', 'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Subjects Receiving Single IV Administration of 18F Fluciclovine for PET Scan', 'description': 'Subjects with a history of brain metastases previously treated with primary, adjuvant or repeat (salvage) radiation therapy, with a recent (within no more than 42 days before the study PET scan) SoC brain MRI found to be equivocal for recurrent brain metastasis, and who met all the inclusion criteria and none of the exclusion criteria, were consented and enrolled into the study. Specifically, subjects had to be planned for further confirmatory diagnostic procedures to confirm the brain MRI findings: either biopsy/neurosurgical intervention, or clinical follow-up, as SoC.'}], 'classes': [{'title': 'Body Temperature: Pre-IMP Injection', 'denoms': [{'units': 'Participants', 'counts': [{'value': '141', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '36.53', 'spread': '0.419', 'groupId': 'OG000'}]}]}, {'title': 'Body Temperature: Post PET Scan', 'denoms': [{'units': 'Participants', 'counts': [{'value': '142', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '36.53', 'spread': '0.455', 'groupId': 'OG000'}]}]}, {'title': 'Body Temperature: Change from Pre to Post', 'denoms': [{'units': 'Participants', 'counts': [{'value': '142', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '-0.00', 'spread': '0.29', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'The vital signs collected between 5 to 60 minutes before and after the PET scan.', 'description': 'Treatment-emergent adverse events (TEAEs) following 18F-fluciclovine injection in the subject population.', 'unitOfMeasure': 'degrees Celsius', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Collected and Reported'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Subjects Receiving Single IV Administration of 18F Fluciclovine for PET Scan', 'description': 'Subjects with a history of brain metastases previously treated with primary, adjuvant or repeat (salvage) radiation therapy, with a recent (within no more than 42 days before the study PET scan) SoC brain MRI found to be equivocal for recurrent brain metastasis, and who met all the inclusion criteria and none of the exclusion criteria, were consented and enrolled into the study. Specifically, subjects had to be planned for further confirmatory diagnostic procedures to confirm the brain MRI findings: either biopsy/neurosurgical intervention, or clinical follow-up, as SoC.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '151'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '151'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '151', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Subjects Receiving Single IV Administration of 18F Fluciclovine for PET Scan', 'description': 'Subjects with a history of brain metastases previously treated with primary, adjuvant or repeat (salvage) radiation therapy, with a recent (within no more than 42 days before the study PET scan) SoC brain MRI found to be equivocal for recurrent brain metastasis, and who met all the inclusion criteria and none of the exclusion criteria, were consented and enrolled into the study. Specifically, subjects had to be planned for further confirmatory diagnostic procedures to confirm the brain MRI findings: either biopsy/neurosurgical intervention, or clinical follow-up, as SoC.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '81', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '70', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '61.8', 'spread': '11.22', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '93', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '58', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '18', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '131', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '7', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '134', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Height (cm)', 'classes': [{'categories': [{'measurements': [{'value': '168.25', 'spread': '10.002', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'cm', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Weight (kg)', 'classes': [{'categories': [{'measurements': [{'value': '78.72', 'spread': '19.665', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Body mass index (kg/m2)', 'classes': [{'categories': [{'measurements': [{'value': '27.66', 'spread': '6.314', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Kg/m2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'ECOG', 'classes': [{'title': '0', 'categories': [{'measurements': [{'value': '40', 'groupId': 'BG000'}]}]}, {'title': '1', 'categories': [{'measurements': [{'value': '96', 'groupId': 'BG000'}]}]}, {'title': '2', 'categories': [{'measurements': [{'value': '15', 'groupId': 'BG000'}]}]}, {'title': '3', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}, {'title': '4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': "ECOG performance status scale describes a patient's level of functioning:\n\n0=fully active, able to carry on as pre-disease without restriction\n\n1. Restricted in physically strenuous activity but ambulatory and able to carry out work of a light nature, e.g., light house work, office work\n2. Ambulatory/capable of all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours\n3. Capable of only limited selfcare; confined to bed or chair more than 50% of waking hours\n4. Completely disabled; cannot carry on any selfcare; totally confined to bed or chair", 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-03-17', 'size': 2104463, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_002.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-07-29T08:46', 'hasProtocol': True}, {'date': '2021-07-13', 'size': 1140214, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_003.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2025-07-29T08:52', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Positron Emission Tomography (PET) Imaging study'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 151}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-10-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2023-06-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-26', 'studyFirstSubmitDate': '2020-05-27', 'resultsFirstSubmitDate': '2025-05-29', 'studyFirstSubmitQcDate': '2020-05-27', 'lastUpdatePostDateStruct': {'date': '2025-08-28', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-08-26', 'studyFirstPostDateStruct': {'date': '2020-06-01', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-08-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2023-06-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Positive Percent Agreement (PPA) and Negative Percent Agreement (NPA) Subject Level', 'timeFrame': 'MRI for anatomical correlation within 3 days of IMP and PET scan, followed by surgical intervention (if applicable) post-PET scan and follow up through 6 months after PET scan.', 'description': 'Subject-level PPA and NPA (equivalent to sensitivity and specificity, respectively) of 18F-fluciclovinePET in detecting recurrent brain metastases.'}], 'secondaryOutcomes': [{'measure': 'Subject Level Positive Predictive Value (PPV) and Negative Predictive Value (NPV)', 'timeFrame': 'MRI for anatomical correlation within 3 days of IMP and PET scan, followed by surgical intervention (if applicable) post-PET scan and follow up through 6 months after PET scan.', 'description': 'Subject-level PPV and NPV of 18F-fluciclovine PET for detecting recurrent brain metastases'}, {'measure': 'Lesion-level Positive Percent Agreement (PPA) and Negative Percent Agreement (NPA)', 'timeFrame': 'MRI for anatomical correlation within 3 days of IMP and PET scan, followed by surgical intervention (if applicable) post-PET scan and follow up through 6 months after PET scan.', 'description': 'To assess lesion-level PPA \\& NPA diagnostic performance of 18F-fluciclovine PET in detecting recurrent brain metastases.'}, {'measure': 'Lesion-level Positive Predictive Value (PPV) and Negative Predictive Value (NPV)', 'timeFrame': 'MRI for anatomical correlation within 3 days of IMP and PET scan, followed by surgical intervention (if applicable) post-PET scan and follow up through 6 months after PET scan.', 'description': 'To assess lesion-level PPV \\& NPV diagnostic performance of 18F-fluciclovine PET in detecting recurrent brain metastases.'}, {'measure': 'Subject-level Positive Percent Agreement (PPA) & Negative Percent Agreement (NPA) Diagnostic Performance of Fluciclovine (18F) PET in Detecting Recurrent Brain Metastases in Different Clinical Settings - Tumor Type', 'timeFrame': 'MRI for anatomical correlation within 3 days of IMP and PET scan, followed by surgical intervention (if applicable) post-PET scan and follow up through 6 months after PET scan.', 'description': 'Sub-group analyses of subject-level PPA \\& NPA of fluciclovine (18F) PET, according to primary tumor type.'}, {'measure': 'Subject-level Positive Predictive Value (PPV) & Negative Predictive Value (NPV) Diagnostic Performance of Fluciclovine (18F) PET in Detecting Recurrent Brain Metastases in Different Clinical Settings - Tumor Type', 'timeFrame': 'MRI for anatomical correlation within 3 days of IMP and PET scan, followed by surgical intervention (if applicable) post-PET scan and follow up through 6 months after PET scan.', 'description': 'Sub-group analyses of subject-level PPV \\& NPV of fluciclovine (18F) PET, according to primary tumor type.'}, {'measure': 'Subject-level Positive Percent Agreement (NPA) & Negative Percent Agreement (NPA) Diagnostic Performance of Fluciclovine (18F) PET in Detecting Recurrent Brain Metastases in Different Clinical Settings - Concurrent Immunotherapy', 'timeFrame': 'MRI for anatomical correlation within 3 days of IMP and PET scan, followed by surgical intervention (if applicable) post-PET scan and follow up through 6 months after PET scan.', 'description': 'Sub-group analyses of subject-level PPA \\& NPA of fluciclovine (18F) PET, according to concurrent immunotherapy.'}, {'measure': 'Subject-level Positive Predictive Value (PPV) & Negative Predictive Value (NPV) Diagnostic Performance of Fluciclovine (18F) PET in Detecting Recurrent Brain Metastases in Different Clinical Settings - Concurrent Immunotherapy', 'timeFrame': 'MRI for anatomical correlation within 3 days of IMP and PET scan, followed by surgical intervention (if applicable) post-PET scan and follow up through 6 months after PET scan.', 'description': 'Sub-group analyses of subject-level PPV \\& NPV of fluciclovine (18F) PET, according to Concurrent Immunotherapy.'}, {'measure': 'Clinical Usefulness', 'timeFrame': 'Follow up through 6 months after PET scan.', 'description': 'Number of days taken by the site to establish presence/absence of metastasis by clinical follow-up.'}, {'measure': 'Clinical Usefulness', 'timeFrame': 'Follow up through 6 months after PET scan.', 'description': 'Proportion of subjects with additional metastases identified on fluciclovine (18F) PET in addition to SoC brain MRI'}, {'measure': 'Clinical Usefulness', 'timeFrame': 'Follow up through 6 months after PET scan.', 'description': 'Proportion of subjects whose prospective diagnostic management plan changed following fluciclovine (18F) PET.'}, {'measure': 'Inter-reader Reproducibility', 'timeFrame': 'PET Scan Day 1', 'description': 'Pairwise comparisons of the central reads for the 3 readers (i.e. Reader 1 vs Reader 2, Reader 1 vs Reader 3, and Reader 2 vs Reader 3) at the subject-level. The percentage of results in agreement (i.e. Positive \\[1st reader\\] / Positive \\[2nd reader\\], Negative/Negative) is presented.'}, {'measure': 'Intra-reader Reproducibility', 'timeFrame': 'PET Scan Day 1', 'description': 'Pairwise comparisons of the initial read vs re-read of a subset of PET scans for each reader at the subject-level. The percentage of results in agreement (i.e. Positive \\[initial read\\] / Positive \\[re-read\\], Negative/Negative) is presented.'}, {'measure': 'Assess the Safety of Fluciclovine (18F) Injection in the Subject Population, Blood Pressure', 'timeFrame': 'The vital signs collected between 5 to 60 minutes before and after the PET scan.', 'description': 'Treatment-emergent adverse events (TEAEs) following 18F-fluciclovine injection in the subject population.'}, {'measure': 'Assess the Safety of Fluciclovine (18F) Injection in the Subject Population, Heart Rate', 'timeFrame': 'The vital signs collected between 5 to 60 minutes before and after the PET scan.', 'description': 'Treatment-emergent adverse events (TEAEs) following 18F-fluciclovine injection in the subject population.'}, {'measure': 'Assess the Safety of Fluciclovine (18F) Injection in the Subject Population, Respiratory Rate', 'timeFrame': 'The vital signs collected between 5 to 60 minutes before and after the PET scan.', 'description': 'Treatment-emergent adverse events (TEAEs) following 18F-fluciclovine injection in the subject population.'}, {'measure': 'Assess the Safety of Fluciclovine (18F) Injection in the Subject Population, Body Temperature', 'timeFrame': 'The vital signs collected between 5 to 60 minutes before and after the PET scan.', 'description': 'Treatment-emergent adverse events (TEAEs) following 18F-fluciclovine injection in the subject population.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Recurrent Brain Metastases', 'Diagnostic', 'Positron Emission Tomography (PET) Scan'], 'conditions': ['Brain Metastases']}, 'referencesModule': {'references': [{'pmid': '34081125', 'type': 'DERIVED', 'citation': 'Kotecha R, Aboian M, Nabavizadeh SA, Parent EE, Trifiletti DM, Chao ST. Letter regarding "Contribution of PET imaging to radiotherapy planning and monitoring in glioma patients-a report of the PET/RANO group": 18F-fluciclovine and target volume delineation. Neuro Oncol. 2021 Aug 2;23(8):1408-1409. doi: 10.1093/neuonc/noab097. No abstract available.'}]}, 'descriptionModule': {'briefSummary': 'An open-label, single dose, single arm, prospective, multicenter Phase 3 study to establish the diagnostic performance of 18F fluciclovine positron emission tomography (PET) in detecting recurrent brain metastases after radiation therapy'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1, or 2 if this is an acute deterioration\n2. Previous history of solid tumor brain metastasis of any origin\n3. Histopathological confirmation of the primary solid tumor or a metastatic site within 4 years\n4. Previous radiation therapy of brain metastatic lesion(s)\n5. A reference lesion considered by the site investigator to be equivocal for recurrent brain metastasis\n6. Patient requires further confirmatory diagnostic procedures to confirm brain MRI findings and is planned for biopsy/neurosurgical intervention as standard of care (SoC) or clinical follow-up as SoC\n\nExclusion Criteria:\n\n1\\. Patients with a history of active hematological malignancy'}, 'identificationModule': {'nctId': 'NCT04410133', 'acronym': 'REVELATE', 'briefTitle': 'Study to Establish the Diagnostic Performance of 18F Fluciclovine PET in Detecting Recurrent Brain Metastases', 'organization': {'class': 'INDUSTRY', 'fullName': 'Blue Earth Diagnostics'}, 'officialTitle': 'An Open-label, Single-arm, Single-dose, Prospective, Multicenter Phase 3 Study to Establish the Diagnostic Performance of 18F-Fluciclovine Positron Emission Tomography (PET) in Detecting Recurrent Brain Metastases After Radiation Therapy', 'orgStudyIdInfo': {'id': 'BED-FLC-312'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Patients', 'description': 'Single intravenous administration of 18F fluciclovine for PET Scan', 'interventionNames': ['Drug: 18F fluciclovine']}], 'interventions': [{'name': '18F fluciclovine', 'type': 'DRUG', 'otherNames': ['Axumin'], 'description': '18F fluciclovine injection, 185 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