Ignite Creation Date:
2025-12-24 @ 11:43 PM
Ignite Modification Date:
2026-02-19 @ 8:37 PM
Study NCT ID:
NCT03675451
Status:
COMPLETED
Last Update Posted:
2020-10-14
First Post:
2016-12-06
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
PSMA Imaging of Localized Prostate Cancer
Sponsor:
Organization:
Raw JSON
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'212.746.5793', 'title': 'Junaid Niaz', 'organization': 'Weill Cornell Medicine'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '1 year, 6 months', 'eventGroups': [{'id': 'EG000', 'title': 'Interventional 89ZR-DF-IAB2M', 'description': '89ZR-DF-IAB2M: injection of 10 milligrams of radioactive 89Zr-Df-IAB2M followed by PET/CT scan', 'otherNumAtRisk': 20, 'deathsNumAtRisk': 20, 'otherNumAffected': 0, 'seriousNumAtRisk': 20, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': '68Ga-PSMA-HBED-CC (5±2mCi)', 'description': "Injection of 68Ga-PSMA-HBED-CC (5±2mCi) injection and PET/CT scan (1 to 3 hours after the injection) will also be performed prior to radical prostatectomy depending on subject's availability and compliance.", 'otherNumAtRisk': 9, 'deathsNumAtRisk': 9, 'otherNumAffected': 0, 'seriousNumAtRisk': 9, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 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[{'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 30 days pre-prostatectomy', 'description': 'Participants underwent 68Ga-PSMA-HBED-CC injection and PET/CT scan (1 to 3 hours after the injection),e performed prior to radical prostatectomy.', 'unitOfMeasure': 'Lesions', 'reportingStatus': 'POSTED', 'populationDescription': '9 of the 20 enrolled subjects were analyzed, as only 9 subjects completed 68Ga-PSMA-HBED-CC PET/CT'}, {'type': 'SECONDARY', 'title': 'The Number of Clinically Significant Lesions Detected by mpMRI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': '89Zr-Df-IAB2M, mpMRI, Prostatectomy', 'description': '19 subjects were imaged with standard of care mpMRI injected with 10 milligrams of radioactive 89Zr-Df-IAB2M followed by PET/CT imaging, followed by prostatectomy'}], 'classes': [{'categories': [{'measurements': [{'value': '18', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 30 days pre-prostatectomy', 'description': 'pre-prostatectomy standard of care mpMRI used to determine the number of clinically significant lesions', 'unitOfMeasure': 'Lesions', 'reportingStatus': 'POSTED', 'populationDescription': '19 of the 20 enrolled subjects were analyzed, as one of the 20 did not follow through with prostatectomy following study 89Zr-df-IAB2M PET/CT, thus pathology is not available.'}, {'type': 'SECONDARY', 'title': 'The Number of Clinically Significant Lesions Detected by mpMRI in the Subset of Subjects Who Underwent 68Ga-PSMA-HBED-CC PET/CT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': '89Zr-df-IAB2M, mpMRI, 68Ga-PSMA-11, and Prostatectomy', 'description': 'A subset of 9 subjects were injected with 68Ga-PSMA-HBED-CC, followed by PET/CT scan (1 to 3 hours after the injection), performed prior to radical 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the injection. This preceded prostatectomy.'}], 'classes': [{'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 30 days pre-prostatectomy', 'description': 'The Number of clinically significant lesions detected by 89Zr-df-IAB2M PET/CT in the subset of subjects who underwent 68Ga-PSMA-HBED-CC Injection and PET/CT', 'unitOfMeasure': 'Lesions', 'reportingStatus': 'POSTED', 'populationDescription': '9 of the 20 enrolled subjects were analyzed, as only 9 subjects completed 68Ga-PSMA-HBED-CC PET/CT'}, {'type': 'SECONDARY', 'title': 'The Number of Lesions Involved in Extra-prostatic Extension Identified Through in Vivo 89Zr-df-IAB2M PET/CT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}, {'units': 'extra-prostatic lesions', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': '89Zr-Df-IAB2M, mpMRI, Prostatectomy', 'description': '19 subjects were imaged with standard of care mpMRI injected with 10 milligrams of radioactive 89Zr-Df-IAB2M followed by PET/CT imaging, followed by prostatectomy'}], 'classes': [{'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_UNITS', 'timeFrame': 'Up to 30 days pre-prostatectomy', 'unitOfMeasure': 'extra-prostatic lesions', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'extra-prostatic lesions', 'denomUnitsSelected': 'extra-prostatic lesions', 'populationDescription': '20 Subjects were injected with 10 milligrams of radioactive 89Zr-Df-IAB2M followed by PET/CT scan. 19 of those 20 completed prostatectomy and have pathology available for analysis.'}, {'type': 'SECONDARY', 'title': 'The Number of Lesions Involved in Extra-prostatic Extension Identified Through 68Ga-PSMA-HBED-CC PET/CT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}, {'units': 'extra-prostatic lesions', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': '89Zr-df-IAB2M, mpMRI, 68Ga-PSMA-11, and Prostatectomy', 'description': 'A subset of 9 subjects were injected with 68Ga-PSMA-HBED-CC, followed by PET/CT scan (1 to 3 hours after the injection), performed prior to radical prostatectomy.'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_UNITS', 'timeFrame': 'Up to 30 days pre-prostatectomy', 'unitOfMeasure': 'extra-prostatic lesions', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'extra-prostatic lesions', 'denomUnitsSelected': 'extra-prostatic lesions', 'populationDescription': 'A subset of 9 subjects were injected with 68Ga-PSMA-HBED-CC followed by PET/CT scan, prior to prostatectomy.'}, {'type': 'SECONDARY', 'title': 'The Number of Occult Lymph Nodes Identified by in Vivo 89Zr-df-IAB2M PET/CT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}]}, {'units': 'Occult Lymph Nodes', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': '89Zr-Df-IAB2M, mpMRI, Prostatectomy', 'description': '19 subjects were imaged with standard of care mpMRI injected with 10 milligrams of radioactive 89Zr-Df-IAB2M followed by PET/CT imaging, followed by prostatectomy\n\nA subset of 9 subjects were injected with 68Ga-PSMA-HBED-CC (5±2mCi), followed by PET/CT scan (1 to 3 hours after the injection), performed prior to radical prostatectomy.'}], 'classes': [{'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_UNITS', 'timeFrame': 'Up to 30 days pre-prostatectomy', 'unitOfMeasure': 'Occult Lymph Nodes', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Occult Lymph Nodes', 'denomUnitsSelected': 'Occult Lymph Nodes', 'populationDescription': '19 of the 20 enrolled subjects were analyzed, as one of the 20 did not follow through with prostatectomy following study 89Zr-df-IAB2M PET/CT, thus pathology is not available.'}, {'type': 'SECONDARY', 'title': 'The Number of Occult Lymph Nodes Identified by in Vivo 68Ga-PSMA-11 PET/CT', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}, {'units': 'Occult Lymph Nodes', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': '89Zr-df-IAB2M, mpMRI, 68Ga-PSMA-11, and Prostatectomy', 'description': 'A subset of 9 participants were injected with 68Ga-PSMA-HBED-CC followed by PET/CT imaging 1 to 3 hours after the injection. This preceded prostatectomy.'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_UNITS', 'timeFrame': 'Up to 30 days pre-prostatectomy', 'unitOfMeasure': 'Occult Lymph Nodes', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Occult Lymph Nodes', 'denomUnitsSelected': 'Occult Lymph Nodes', 'populationDescription': 'A subset of 9 of the 20 subjects were analyzed, as only 9 subjects completed 68Ga-PSMA-HBED-CC PET/CT. All 9 of those subjects had post-prostatectomy pathology for analysis.'}, {'type': 'SECONDARY', 'title': 'The Number of Observed or Reported Treatment-Emergent Adverse Events Following 89ZR-DF-IAB2M PET/CT (Positron Emission Tomography-Computed Tomography)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': '89Zr-Df-IAB2M, mpMRI', 'description': '20 subjects were imaged with standard of care mpMRI injected with 10 milligrams of radioactive 89Zr-Df-IAB2M followed by PET/CT imaging.\n\nA subset of 19 subjects underwent prostatectomy following imaging\n\nA subset of 9 subjects were injected with 68Ga-PSMA-HBED-CC (5±2mCi), followed by PET/CT scan (1 to 3 hours after the injection), performed prior to radical prostatectomy.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 30 days pre-prostatectomy', 'description': 'All AEs, including 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'Male', 'measurements': [{'value': '20', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-05-31', 'size': 967051, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2020-01-23T18:02', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-02-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'completionDateStruct': {'date': '2018-06-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-09-18', 'studyFirstSubmitDate': '2016-12-06', 'resultsFirstSubmitDate': '2020-08-18', 'studyFirstSubmitQcDate': '2018-09-04', 'lastUpdatePostDateStruct': {'date': '2020-10-14', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-09-18', 'studyFirstPostDateStruct': {'date': '2018-09-18', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2020-10-14', 'type': 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'Up to 30 days pre-prostatectomy', 'description': 'The Number of Clinically Significant Lesions Detected by mpMRI in subjects who underwent 68Ga-PSMA-HBED-CC injection and PET/CT'}, {'measure': 'The Number of Clinically Significant Lesions Detected by 89Zr-df-IAB2M PET/CT in the Subset of Subjects Who Underwent 68Ga-PSMA-HBED-CC PET/CT', 'timeFrame': 'Up to 30 days pre-prostatectomy', 'description': 'The Number of clinically significant lesions detected by 89Zr-df-IAB2M PET/CT in the subset of subjects who underwent 68Ga-PSMA-HBED-CC Injection and PET/CT'}, {'measure': 'The Number of Lesions Involved in Extra-prostatic Extension Identified Through in Vivo 89Zr-df-IAB2M PET/CT', 'timeFrame': 'Up to 30 days pre-prostatectomy'}, {'measure': 'The Number of Lesions Involved in Extra-prostatic Extension Identified Through 68Ga-PSMA-HBED-CC PET/CT', 'timeFrame': 'Up to 30 days pre-prostatectomy'}, {'measure': 'The Number of Occult Lymph Nodes Identified by in Vivo 89Zr-df-IAB2M PET/CT', 'timeFrame': 'Up to 30 days pre-prostatectomy'}, {'measure': 'The Number of Occult Lymph Nodes Identified by in Vivo 68Ga-PSMA-11 PET/CT', 'timeFrame': 'Up to 30 days pre-prostatectomy'}, {'measure': 'The Number of Observed or Reported Treatment-Emergent Adverse Events Following 89ZR-DF-IAB2M PET/CT (Positron Emission Tomography-Computed Tomography)', 'timeFrame': 'Up to 30 days pre-prostatectomy', 'description': 'All AEs, including unrelated AEs, expected, and unexpected AEs were included in the counts of adverse events'}, {'measure': 'The Number of Observed or Reported Treatment-Emergent Adverse Events Following 68Ga-PSMA-HBED-CC PET/CT', 'timeFrame': 'Up to 30 days pre-prostatectomy', 'description': 'All AEs, including unrelated AEs, expected, and unexpected AEs were included in the counts of adverse events'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['PET/CT', 'Imaging', 'Nuclear Medicine'], 'conditions': ['Prostate Cancer']}, 'descriptionModule': {'briefSummary': "The present study is a phase II, open label, single-center, non-randomized, single-dose study.\n\nTwenty subjects in total will be enrolled at Weill Cornell Medical College (WCMC)/ NYPH.\n\nThe primary objective is to evaluate the ability of 89Zr-Df-IAB2M to detect localized, clinically significant (defined as: ≥ 0.5 cm3 with Gleason pattern ≥ 4) prostate cancer (PCa).\n\nAfter the screening period (up to 28 days), each subject will be scheduled to receive 10 mg infusion of IAB2M conjugated with 2.5 mCi 89Zr-Df.\n\n2 - 4 days post-infusion, subjects will undergo a 89Zr-Df-IAB2M PET/CT scan. Images read by a Nuc Med MD reporting: location, SUV and, if possible, size of all areas with abnormal uptake.\n\n(they will also undergo a pelvic MRI if they have not obtained an MR image during the screening period or on day of infusion)\n\nOptional but recommended 68Ga-PSMA-HBED-CC (5±2mCi) injection and PET/CT scan (1 to 3 hours after the injection) will also be performed prior to radical prostatectomy depending on subject's availability and compliance.\n\nPatient will undergo radical prostatectomy after completion of above imaging procedures.", 'detailedDescription': 'The primary endpoint of this study is the proportion of subjects with PSMA-positive (identified by H\\&E staining and immunohistochemistry) "dominant" PC lesion(s) greater than 5mm in diameter, whose lesion(s) have been successfully identified by 89Zr-Df-IAB2M imaging. Because this is an exploratory pilot study, no formal sample size/power calculation is required. However, with a sample size of 20 patients in the study, a two-sided 95% confidence interval for the proportion of patients successfully imaged by 89Zr-Df-IAB2M can be constructed to be within ± 19.0% of the observed proportion of patients with successful imaging by 89Zr-Df-IAB2M. This calculation assumes an 89Zr-Df-IAB2M imaging-success proportion of 75%. All estimates from the study will serve as preliminary data (i.e., hypothesis-generating) for future studies.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients must have histologically or cytologically confirmed localized prostate cancer that are scheduled to undergo radical prostatectomy.\n* Age \\>18 years.\n* Patients must have laboratory values consistent with eligibility to undergo a radical prostatectomy:\n\n * creatinine less than or equal to 1.5 X upper limit of normal\n * creatinine clearance \\> 60 mL/min\n* The effects of 89Zr-Df-IAB2M on the developing human fetus at the recommended therapeutic dose are unknown. For this reason, men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while her male partner is participating in this study, she should inform her treating physician immediately.\n* Ability to understand and the willingness to sign a written informed consent document.\n\nExclusion Criteria:\n\n* Treatment or plans for treatment with radiation therapy, surgery, chemotherapy, or investigational therapy between the time of conventional imaging, 89Zr-Df-IAB2M PET/CT and the surgical resection used for the study evaluation.\n* Transrectal prostate biopsy performed less than four weeks prior to 89Zr-Df-IAB2M administration.\n* Uncontrolled illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.'}, 'identificationModule': {'nctId': 'NCT03675451', 'briefTitle': 'PSMA Imaging of Localized Prostate Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Weill Medical College of Cornell University'}, 'officialTitle': 'PSMA Imaging of Localized Prostate Cancer', 'orgStudyIdInfo': {'id': '1311014489'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Interventional', 'description': "Injection of study drug followed by PET/CT imaging.\n\nOptional but recommended 68Ga-PSMA-HBED-CC (5±2mCi) injection and PET/CT scan (1 to 3 hours after the injection) will also be performed prior to radical prostatectomy depending on subject's availability and compliance.\n\nFollowed by prostatectomy", 'interventionNames': ['Drug: 89ZR-DF-IAB2M', 'Drug: 68Ga-PSMA-HBED-CC']}], 'interventions': [{'name': '89ZR-DF-IAB2M', 'type': 'DRUG', 'description': 'injection of 10 milligrams of radioactive 89Zr-Df-IAB2M followed by PET/CT scan', 'armGroupLabels': ['Interventional']}, {'name': '68Ga-PSMA-HBED-CC', 'type': 'DRUG', 'description': "Optional but recommended 68Ga-PSMA-HBED-CC (5±2mCi) injection and PET/CT scan (1 to 3 hours after the injection) will also be performed prior to radical prostatectomy depending on subject's availability and compliance.", 'armGroupLabels': ['Interventional']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10065', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Weill Cornell Medicine', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Douglas S Scherr, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Weill Medical College of Cornell University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Weill Medical College of Cornell University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}