Ignite Creation Date:
2025-12-24 @ 6:56 PM
Ignite Modification Date:
2025-12-27 @ 1:55 PM
Study NCT ID:
NCT04217057
Status:
TERMINATED
Last Update Posted:
2024-11-19
First Post:
2019-12-30
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Imaging CCR2 Receptors With 64Cu-DOTA-ECL1i in Head and Neck Cancer
Sponsor:
Organization:
Raw JSON
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'otherNumAtRisk': 11, 'deathsNumAtRisk': 11, 'otherNumAffected': 2, 'seriousNumAtRisk': 11, 'deathsNumAffected': 1, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (Unspecified)'}, {'term': 'Dysesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (Unspecified)'}, {'term': 'Laryngeal inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 11, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'ct'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Diagnostic Quality of 64Cu-DOTA-ECL1i-PET/CT Images as Measured by Assessment of Overall Image Quality: 4 Point Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': '64Cu-DOTA-ECL1i-PET/CT', 'description': '-64CU-DOTA-ECL1i-PET/CT imaging consisting of a dynamic scan centered at the level of the known tumor followed by a limited body scan of the head/neck and upper chest will be performed'}], 'classes': [{'title': 'Score of 1', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Score of 2', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Score of 3', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Score of 4', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At the time of scan (Day 1)', 'description': '-Overall image quality will be graded on a 4 point scale with 1 being the worse and poor quality, not acceptable for diagnostic interpretation and 4 being good image quality, similar to routine clinical studies', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Diagnostic Quality of 64Cu-DOTA-ECL1i-PET/CT Images as Measured by Presence or Absence of Abnormal 64Cu-DOT-ECL1i Uptake in Pathologically Proven Site of Disease', 'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': '64Cu-DOTA-ECL1i-PET/CT', 'description': '-64CU-DOTA-ECL1i-PET/CT imaging consisting of a dynamic scan centered at the level of the known tumor followed by a limited body scan of the head/neck and upper chest will be performed'}], 'classes': [{'title': 'Presence of abnormal 64Cu-DOT-ECL1i uptake', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}]}]}, {'title': 'Absence of abnormal 64Cu-DOT-ECL1i uptake', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At the time of scan (Day 1)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'CCR2 Detection Rate of 64Cu-DOTA-ECL1i-PET/CT as Measured by IHC Staining', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': '64Cu-DOTA-ECL1i-PET/CT', 'description': '-64CU-DOTA-ECL1i-PET/CT imaging consisting of a dynamic scan centered at the level of the known tumor followed by a limited body scan of the head/neck and upper chest will be performed'}], 'classes': [{'title': '0=absent/faint', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': '1=weak', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': '2=moderate', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': '3=strong', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At the time of standard of care surgery (estimated to be within 2 weeks of imaging)', 'description': '-Intensity of CCR2 signal in IHC will be assessed by the study pathologist and categorized into 4 categories (0=absent/faint, 1=weak, 2=moderate, 3=strong). Any cells that stained positively with CCR2 will be assessed and the final score will be based on an overall assessment of CCR2 IHC on all of these cells.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'One participant did not have tissue avaiable.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '64Cu-DOTA-ECL1i-PET/CT', 'description': '-64CU-DOTA-ECL1i-PET/CT imaging consisting of a dynamic scan centered at the level of the known tumor followed by a limited body scan of the head/neck and upper chest will be performed'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '11'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '11', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': '64Cu-DOTA-ECL1i-PET/CT', 'description': '-64CU-DOTA-ECL1i-PET/CT imaging consisting of a dynamic scan centered at the level of the known tumor followed by a limited body scan of the head/neck and upper chest will be performed'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '62', 'groupId': 'BG000', 'lowerLimit': '56', 'upperLimit': '77'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '10', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '11', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '00', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '11', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-08-28', 'size': 1116859, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-01-05T07:02', 'hasProtocol': True}, {'date': '2023-09-19', 'size': 291488, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2024-10-30T13:03', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 11}}, 'statusModule': {'whyStopped': 'Insufficient funding/staff', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2020-02-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2023-02-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-10-30', 'studyFirstSubmitDate': '2019-12-30', 'resultsFirstSubmitDate': '2024-01-31', 'studyFirstSubmitQcDate': '2020-01-02', 'lastUpdatePostDateStruct': {'date': '2024-11-19', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-01-31', 'studyFirstPostDateStruct': {'date': '2020-01-03', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-02-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-02-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Diagnostic Quality of 64Cu-DOTA-ECL1i-PET/CT Images as Measured by Assessment of Overall Image Quality: 4 Point Scale', 'timeFrame': 'At the time of scan (Day 1)', 'description': '-Overall image quality will be graded on a 4 point scale with 1 being the worse and poor quality, not acceptable for diagnostic interpretation and 4 being good image quality, similar to routine clinical studies'}, {'measure': 'Diagnostic Quality of 64Cu-DOTA-ECL1i-PET/CT Images as Measured by Presence or Absence of Abnormal 64Cu-DOT-ECL1i Uptake in Pathologically Proven Site of Disease', 'timeFrame': 'At the time of scan (Day 1)'}, {'measure': 'CCR2 Detection Rate of 64Cu-DOTA-ECL1i-PET/CT as Measured by IHC Staining', 'timeFrame': 'At the time of standard of care surgery (estimated to be within 2 weeks of imaging)', 'description': '-Intensity of CCR2 signal in IHC will be assessed by the study pathologist and categorized into 4 categories (0=absent/faint, 1=weak, 2=moderate, 3=strong). Any cells that stained positively with CCR2 will be assessed and the final score will be based on an overall assessment of CCR2 IHC on all of these cells.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Head and Neck Cancer']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.siteman.wustl.edu', 'label': 'Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine'}]}, 'descriptionModule': {'briefSummary': 'CCR2 is a significant prognostic biomarker in head and neck cancer. Currently there is no clinical biomarker to study CCR2, its prognostic significance or to select patients for CCR2-targeted therapy and to monitor response to such therapy. The investigators have developed a CCR2 specific PET radiotracer based on the peptide, ECL1i (d(LGTFLKC)) and radiolabeled with 64Cu (64Cu-DOTA-ECL1i). The investigators have found that 64Cu-DOTA-ELC1i specific binding has been demonstrated in human head and neck cancer tissue.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patient 18 years of age or older\n* Cytology or biopsy-proven squamous cell head and neck cancer scheduled to be treated with standard of care surgery. Patients who are not surgical candidates should have adequate tissue from tumor biopsy for analysis of CCR2\n* Lesion size of at least 1.5 cm (treatment naïve)\n* Able to give informed consent\n* Not currently pregnant or nursing: Subject must be surgically sterile (has had a documented bilateral oophorectomy and/or documented hysterectomy), post menopausal (cessation of menses for more than 1 year), non-lactating, or of childbearing potential for whom a urine pregnancy test (with the test performed within the 14 hour period immediately prior to administration of 64Cu-DOTA-ECL1i is negative\n\nExclusion Criteria:\n\n* Patients with other invasive malignancies, with the exception of non-melanoma skin cancer, who had (or have) any evidence of the other cancer present within the last 2 years\n* Unable to tolerate approximately 90 minutes (total time) of PET/CT imaging'}, 'identificationModule': {'nctId': 'NCT04217057', 'briefTitle': 'Imaging CCR2 Receptors With 64Cu-DOTA-ECL1i in Head and Neck Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Washington University School of Medicine'}, 'officialTitle': 'Imaging CCR2 Receptors With 64Cu-DOTA-ECL1i in Head and Neck Cancer', 'orgStudyIdInfo': {'id': '201912003'}, 'secondaryIdInfos': [{'id': '1P41EB025815-01', 'link': 'https://reporter.nih.gov/quickSearch/1P41EB025815-01', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '64Cu-DOTA-ECL1i-PET/CT', 'description': '-64CU-DOTA-ECL1i-PET/CT imaging consisting of a dynamic scan centered at the level of the known tumor followed by a limited body scan of the head/neck and upper chest will be performed', 'interventionNames': ['Drug: 64Cu-DOTA-ECL1i']}], 'interventions': [{'name': '64Cu-DOTA-ECL1i', 'type': 'DRUG', 'description': 'Will be produced by the Cyclotron Facility at Washington University School of Medicine', 'armGroupLabels': ['64Cu-DOTA-ECL1i-PET/CT']}]}, 'contactsLocationsModule': {'locations': [{'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Washington University School of Medicine', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}], 'overallOfficials': [{'name': 'Farrokh Dehdashti, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Washington University School of Medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Washington University School of Medicine', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institutes of Health (NIH)', 'class': 'NIH'}, {'name': 'National Institute for Biomedical Imaging and Bioengineering (NIBIB)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}