Ignite Creation Date:
2025-12-24 @ 5:24 PM
Ignite Modification Date:
2026-02-20 @ 12:42 PM
Study NCT ID:
NCT01755650
Status:
TERMINATED
Last Update Posted:
2023-09-13
First Post:
2012-12-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase 0 of 18F FPM Using PET/CT in Patients With a Variety of Malignancies
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002294', 'term': 'Carcinoma, Squamous Cell'}], 'ancestors': [{'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D018307', 'term': 'Neoplasms, Squamous Cell'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 6}}, 'statusModule': {'whyStopped': '6 patients were recuited. Due to inability of the tracer to detect regions of interest sufficiently, the trial was closed early.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2011-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2017-11-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-09-08', 'studyFirstSubmitDate': '2012-12-16', 'studyFirstSubmitQcDate': '2012-12-19', 'lastUpdatePostDateStruct': {'date': '2023-09-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-12-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-11-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety of D-18F FPM and L-18F FPM administration as measured by occurrence of adverse clinical, biochemical or haematological events following 18F FPM administration', 'timeFrame': 'Up to 28 days following 18F FPM administration (+/- 7 days)'}], 'secondaryOutcomes': [{'measure': 'Percentage of injected D-18F FPM and L-18F FPM dose in organs of interest.', 'timeFrame': '10, 30, 60 and 120 minutes post 18F FPM administration'}, {'measure': 'Percentage of unmetabolized D-18F FPM and L-18F FPM in plasma and urine after radiotracer administration.', 'timeFrame': '30 (plasma only) and 90 (plasma and urine) minutes post 18F FPM administration'}, {'measure': 'Absorbed organ doses expressed as micro Sv/MBq of administered D-18F FPM and L-18F FPM, and whole body dose expressed as milliSv/200MBq of administered dose', 'timeFrame': '10, 30, 60 and 120 minutes post 18F FPM administration'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['18F FPM', 'PET/CT', 'microdosing'], 'conditions': ['Squamous Cell Carcinoma']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate the safety and potential effectiveness of the imaging compound 18F FPM for finding sites of malignancies.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Written informed consent obtained prior to any protocol-specific procedures\n* Male and female patients with histologically confirmed squamous cell carcinoma\n* At least one site of active malignancy, as demonstrated on the pre-study 18F FDG PET/CT scan performed as part of routine clinical care\n* Age \\>/= 18 years\n* Life expectancy \\>/= 3 months\n* ECOG Performance score of 0-2\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding females\n* Systemic anti-neoplastic therapy within the 2 weeks prior to the pre-study 18F FDG PET/CT scan until after the 18F FPM PET/CT scan\n* Any serious medical condition which the investigator feels may interfere with the procedures or evaluations of the study\n* Patients unwilling or unable to comply with protocol or with a history of non-compliance or inability to grant informed consent'}, 'identificationModule': {'nctId': 'NCT01755650', 'briefTitle': 'Phase 0 of 18F FPM Using PET/CT in Patients With a Variety of Malignancies', 'organization': {'class': 'OTHER', 'fullName': 'Peter MacCallum Cancer Centre, Australia'}, 'officialTitle': 'A Phase 0 Exploratory Microdosing Study of S-(3-18Ffluoropropyl)Homocysteine Hydrochloride; 18FFPM Using PET/CT in Patients With a Variety of Malignancies.', 'orgStudyIdInfo': {'id': '11/31'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'D-18F FPM', 'interventionNames': ['Radiation: 18F FPM']}, {'type': 'EXPERIMENTAL', 'label': 'L-18F FPM', 'interventionNames': ['Radiation: 18F FPM']}], 'interventions': [{'name': '18F FPM', 'type': 'RADIATION', 'armGroupLabels': ['D-18F FPM', 'L-18F FPM']}]}, 'contactsLocationsModule': {'locations': [{'city': 'East Melbourne', 'state': 'Victoria', 'country': 'Australia', 'facility': 'Peter MacCallum Cancer Centre', 'geoPoint': {'lat': -37.81667, 'lon': 144.9879}}], 'overallOfficials': [{'name': 'Ben Solomon', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Peter MacCallum Cancer Centre, Australia'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Peter MacCallum Cancer Centre, Australia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}