Ignite Creation Date:
2025-12-25 @ 2:54 AM
Ignite Modification Date:
2026-03-01 @ 6:02 AM
Study NCT ID:
NCT06474533
Status:
RECRUITING
Last Update Posted:
2025-03-21
First Post:
2024-06-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Fluoroethyltyrosine for the Evaluation of Intracranial Neoplasm
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001932', 'term': 'Brain Neoplasms'}], 'ancestors': [{'id': 'D016543', 'term': 'Central Nervous System Neoplasms'}, {'id': 'D009423', 'term': 'Nervous System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000615276', 'term': 'Fluorine-18'}, {'id': 'C545932', 'term': '(18F)fluoroethyltyrosine'}, {'id': 'C117289', 'term': 'O-(2-fluoroethyl)tyrosine'}, {'id': 'D009682', 'term': 'Magnetic Resonance Spectroscopy'}], 'ancestors': [{'id': 'D013057', 'term': 'Spectrum Analysis'}, {'id': 'D002623', 'term': 'Chemistry Techniques, Analytical'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 199}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-06-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2028-08-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-19', 'studyFirstSubmitDate': '2024-06-19', 'studyFirstSubmitQcDate': '2024-06-19', 'lastUpdatePostDateStruct': {'date': '2025-03-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-06-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-08-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum Intracranial lesion tumor-to-background ratio (TBRmax)', 'timeFrame': 'Up to 3 years', 'description': 'The maximum TBR (TBRmax) will be calculated by dividing the SUVmean of the 1.6 centimeter (cm) diameter circular region of interest (ROI) by the mean standardized uptake value (SUVmean) of background normal tissue.'}, {'measure': 'Percentage of accurate prediction of presence of tumor (Population 1)', 'timeFrame': 'Up to 3 years', 'description': 'The percentage of radiological read responses that accurately predict the presence of recurrent tumor in patients previously treated with surgery and/or radiation for population 1, broken down by metastatic disease, high-grade gliomas and low-grade gliomas will be reported'}, {'measure': 'Percentage of radiological read responses', 'timeFrame': 'Up to 3 years', 'description': 'The percentage of radiological reads with a binary characterization of scan study as positive for recurrence disease in population 1, and positive for high-grade glial neoplasm in population 2 will be reported.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Imaging Studies'], 'conditions': ['Intracranial Neoplasm']}, 'descriptionModule': {'briefSummary': 'This is a single center study investigating the use of Fluoroethyltyrosine (FET) in the detection of brain tumors. FET accumulates in malignant cells within intracranial neoplasms and can be used to detect recurrent disease and characterize grade of glial neoplasms.', 'detailedDescription': 'PRIMARY OBJECTIVES:\n\n1. To determine if FET Positron Emission Tomography (PET) scan can differentiate between benign treatment-related changes and recurrence in comparison to pathology in population 1 with recurrent metastatic disease and high-grade gliomas.\n2. To determine if FET PET scan can differentiate between low-grade and high-grade gliomas in population 2.\n\nSECONDARY OBJECTIVES:\n\n1. To determine if FET PET scan can differentiate between benign treatment- related changes and recurrence in comparison to pathology or imaging follow-up in population 1.\n2. To determine if FET PET scan can differentiate between benign treatment- related changes and recurrence in comparison to pathology in population 1 with recurrent low-grade gliomas.\n\nEXPLORATORY OBJECTIVES:\n\n1\\. To assess relationships between serial FET PET scan and clinical outcome in population 1 with recurrent metastatic disease and gliomas.\n\nOUTLINE:\n\nParticipants will receive a single PET scan lasting for about 40 minutes in an outpatient setting after an injection with FET. Adult participants may undergo up to two repeat FET PET scans. Adverse events will be recorded.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '4 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adults and children over the age of 3 with intracranial neoplasms (glial or metastatic disease).', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Presence or suspicion of intracranial neoplasm in two populations:\n\n * Population 1: Participants after primary treatment (radiation therapy and/or surgery) with suspicion of recurrence on MRI.\n * Three sub-populations will be considered:\n\n * Recurrent metastatic lesions.\n * Recurrent high-grade gliomas (Grades 3 and 4).\n * Recurrent low-grade gliomas (Grade 2).\n * Population 2: Participants prior to primary treatment with planned biopsy or surgical resection.\n* Age \\> 3 years.\n\nParticipants in other clinical trials will be eligible for this study including patients undergoing surgery guided by 5-aminolevulinic acid.\n\nExclusion Criteria:\n\n* Participants with known incompatibility to PET or Computerized tomography (CT)/magnetic resonance imaging (MRI) scans.\n* Participants unlikely to comply with study procedures, restrictions and requirements and judged by the Investigator to be unsuitable for study participation.\n\n * Sedation or anesthesia can be used for participants who cannot tolerate the exam.'}, 'identificationModule': {'nctId': 'NCT06474533', 'briefTitle': 'Fluoroethyltyrosine for the Evaluation of Intracranial Neoplasm', 'organization': {'class': 'OTHER', 'fullName': 'University of California, San Francisco'}, 'officialTitle': 'Fluoroethyltyrosine for the Evaluation of Intracranial Neoplasm', 'orgStudyIdInfo': {'id': '24924'}, 'secondaryIdInfos': [{'id': 'NCI-2024-04996', 'type': 'REGISTRY', 'domain': 'NCI Clinical Trials Reporting Program (CTRP)'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Population 1: Participants with intracranial neoplasms', 'description': 'Participants with intracranial neoplasms (glial or metastatic disease) with concern for recurrence or progression on conventional imaging.', 'interventionNames': ['Drug: Fluorethyltyrosine (18-F)', 'Procedure: Positron Emission Tomography (PET)']}, {'label': 'Population 2: Participants with suspected glial neoplasms', 'description': 'Participants with suspected glial neoplasms (Grade 2 - 4) planning to undergo biopsy or surgery prior to non-investigational, standard-of-care, primary treatment (radiation therapy and/or surgery)', 'interventionNames': ['Drug: Fluorethyltyrosine (18-F)', 'Procedure: Positron Emission Tomography (PET)']}], 'interventions': [{'name': 'Fluorethyltyrosine (18-F)', 'type': 'DRUG', 'otherNames': ['Fluoroethyltyrosine (FET)', 'FET', 'O-(2-[18F]fluoroethyl)-L-tyrosine (FET)'], 'description': 'Given intravenously (IV)', 'armGroupLabels': ['Population 1: Participants with intracranial neoplasms', 'Population 2: Participants with suspected glial neoplasms']}, {'name': 'Positron Emission Tomography (PET)', 'type': 'PROCEDURE', 'otherNames': ['PET scan', 'PET'], 'description': 'Undergo Imaging Procedure', 'armGroupLabels': ['Population 1: Participants with intracranial neoplasms', 'Population 2: Participants with suspected glial neoplasms']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94143', 'city': 'San Francisco', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Louise Magat', 'role': 'CONTACT', 'email': 'Louise.Magat@ucsf.edu', 'phone': '415-502-1822'}, {'role': 'CONTACT', 'email': 'cancertrials@ucsf.edu', 'phone': '(887) 827-3222'}, {'name': 'Javier Villanueva-Meyer, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Thomas Hope, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'University of California, San Francisco', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}], 'centralContacts': [{'name': 'Louise Magat', 'role': 'CONTACT', 'email': 'Louise.Magat@ucsf.edu', 'phone': '(415) 502-1822'}], 'overallOfficials': [{'name': 'Javier Villanueva-Meyer, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, San Francisco'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Thomas Hope', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Co-Principal Investigator, IND Holder', 'investigatorFullName': 'Thomas Hope', 'investigatorAffiliation': 'University of California, San Francisco'}}}}