Ignite Creation Date:
2025-12-24 @ 10:55 PM
Ignite Modification Date:
2025-12-30 @ 2:39 PM
Study NCT ID:
NCT01933269
Status:
WITHDRAWN
Last Update Posted:
2018-02-05
First Post:
2013-08-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
FACBC for Head and Neck Cancers
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Change in Principal Investigator and protocol revisions delayed study start and ultimately the decision was made to cancel the study.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2015-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-02', 'completionDateStruct': {'date': '2018-02-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-02-01', 'studyFirstSubmitDate': '2013-08-16', 'studyFirstSubmitQcDate': '2013-08-30', 'lastUpdatePostDateStruct': {'date': '2018-02-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-09-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-02-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The presence of FACBC radiotracer uptake in Head and neck tumors on PET scans', 'timeFrame': '1 day', 'description': 'The results of the FACBC PET scan will be validated by direct comparison with the pathology findings obtained at surgery. .'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Cancers of the Head and Neck']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess a relatively new PET (Positron emission tomography) radiotracer called FACBC in the assessment of head and neck cancer. FDG (Flourine Deoxyglucose) is currently used for PET imaging, but has limitations in head and neck cancer. These limitations include problems with specificity, high background uptake from normal structures, difficulty delineating intracranial invasion, and the need to wait several weeks after chemotherapy and radiation before imaging. As an amino acid radiotracer, rather than a glucose radiotracer, FACBC overcomes some of these limitations. FACBC does not yet have FDA (Food and Drug Administration) approval, but does show promise in initial work in patients with prostate cancer and brain tumors. Dosimetry work on FACBC has been performed at Emory.\n\nOur study is a pilot study looking at 10 patients with a new diagnosis of biopsy proven squamous cell carcinoma of the oral cavity who will be able to go on to definitive surgical resection (ie, surgery without preceding chemotherapy or radiation). Patients must have pre-surgical imaging, either with a contrast enhanced CT, FDG PET, or MRI. Patients who consent to participate will receive one FACBC PET/CT of the neck, which will require a low dose "transmission" CT of the neck, an intravenous injection of the radiotracer, and imaging of the neck that will last up to 1 hour. Patients will have to lie still during the imaging time. Total participation time including set up should be less than 90 minutes. Imaging results will be analyzed and compared with conventional imaging as well as the surgical pathology results'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age 18 years or older.\n2. Biopsy proven, untreated squamous cell carcinoma of the oral cavity.\n3. Clinical, laboratory, or diagnostic imaging findings on CT, MRI, or 18F-FDG PET/CT.\n4. Ability to lie still for PET scanning.\n5. Able to provide written informed consent.\n\nExclusion Criteria:\n\n1. Age less than 18 years.\n2. Prior history of carcinoma.\n3. Not a candidate for surgical resection based upon clinical condition or discovery of metastatic disease which would preclude surgical therapy.\n4. Inability to lie still for PET scanning.\n5. Inability to provide written informed consent.'}, 'identificationModule': {'nctId': 'NCT01933269', 'briefTitle': 'FACBC for Head and Neck Cancers', 'organization': {'class': 'OTHER', 'fullName': 'Emory University'}, 'officialTitle': 'Initial Evaluation of Anti-1-amino-F-18 Flurocyclobutane-1carboxylic Acid (Anti-18F-FACBC) in the Assessment of Head and Neck Cancer: A Pilot Study.', 'orgStudyIdInfo': {'id': 'IRB00062214'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'FACBC', 'interventionNames': ['Drug: FACBC']}], 'interventions': [{'name': 'FACBC', 'type': 'DRUG', 'armGroupLabels': ['FACBC']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Ayse Karagulle Kendi, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Emory University'}, {'name': 'David Schuster, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Emory University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Emory University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'David M. Schuster, MD', 'investigatorAffiliation': 'Emory University'}}}}