Ignite Creation Date:
2025-12-24 @ 9:47 PM
Ignite Modification Date:
2025-12-25 @ 7:26 PM
Study NCT ID:
NCT01165632
Status:
COMPLETED
Last Update Posted:
2025-09-02
First Post:
2010-07-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Fluorine F 18 Fluorodopa-Labeled PET Scan in Planning Surgery and Radiation Therapy in Treating Patients With Newly Diagnosed High- or Low-Grade Malignant Glioma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001254', 'term': 'Astrocytoma'}, {'id': 'D004806', 'term': 'Ependymoma'}, {'id': 'D009837', 'term': 'Oligodendroglioma'}, {'id': 'D005909', 'term': 'Glioblastoma'}, {'id': 'D018316', 'term': 'Gliosarcoma'}, {'id': 'D005910', 'term': 'Glioma'}, {'id': 'D018315', 'term': 'Glioma, Subependymal'}], 'ancestors': [{'id': 'D018302', 'term': 'Neoplasms, Neuroepithelial'}, {'id': 'D017599', 'term': 'Neuroectodermal Tumors'}, {'id': 'D009373', 'term': 'Neoplasms, Germ Cell and Embryonal'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001706', 'term': 'Biopsy'}, {'id': 'D011878', 'term': 'Radiotherapy'}, {'id': 'D011827', 'term': 'Radiation'}, {'id': 'D009682', 'term': 'Magnetic Resonance Spectroscopy'}, {'id': 'C062942', 'term': "2-phenyl-6-(2'-(4'-(ethoxycarbonyl)thiazolyl))thiazolo(3,2-b)(1,2,4)triazole"}, {'id': 'C043437', 'term': 'fluorodopa F 18'}], 'ancestors': [{'id': 'D003581', 'term': 'Cytodiagnosis'}, {'id': 'D003584', 'term': 'Cytological Techniques'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D003949', 'term': 'Diagnostic Techniques, Surgical'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D055585', 'term': 'Physical Phenomena'}, {'id': 'D013057', 'term': 'Spectrum Analysis'}, {'id': 'D002623', 'term': 'Chemistry Techniques, Analytical'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-07-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2019-07-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-08-29', 'studyFirstSubmitDate': '2010-07-14', 'studyFirstSubmitQcDate': '2010-07-16', 'lastUpdatePostDateStruct': {'date': '2025-09-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-07-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-11-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '18F-FDOPA PET activity, MRI contrast enhancement, and high- or low-grade glioma biopsies', 'timeFrame': 'Up to 2 years', 'description': 'Determine correlation between 18F-FDOPA PET activity, MRI contrast enhancement, and high- or low-grade glioma biopsies.'}, {'measure': '18F- FDOPA-PET metabolic imaging information', 'timeFrame': 'Up to 2 years', 'description': 'Compare radiotherapy target volume delineation with and without 18F- FDOPA-PET metabolic imaging information to determine role of metabolic imaging in radiotherapy treatment planning.'}], 'secondaryOutcomes': [{'measure': 'Concordance of 18F-FDOPA PET and 11C-choline activity, MRI contrast enhancement, and high- or low-grade glioma biopsies', 'timeFrame': 'Up to 2 years', 'description': 'Determine correlation between concordance of 18F-FDOPA PET and 11C-choline activity, MRI contrast enhancement, and high- or low-grade glioma biopsies and patient outcomes including overall survival and progression free survival.'}, {'measure': 'With and without 18F- FDOPA PET, 11C-choline PET metabolic imaging information', 'timeFrame': '2 Years', 'description': 'Compare radiotherapy target volume delineation with and without 18F- FDOPA PET, 11C-choline PET metabolic imaging information; pMRI and DTI advanced MR imaging, to determine role in radiotherapy treatment planning.'}, {'measure': '18F-FDOPA PET activity, 11C-choline PET activity, MRI contrast enhancement, pMRI, and DTI, with high- or low-grade glioma biopsies', 'timeFrame': '2 years', 'description': 'Determine correlation between 18F-FDOPA PET activity, 11C-choline PET activity, MRI contrast enhancement, pMRI, and DTI, with high- or low-grade glioma biopsies.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Adult Anaplastic Astrocytoma', 'Adult Anaplastic Ependymoma', 'Adult Anaplastic Oligodendroglioma', 'Adult Brain Stem Glioma', 'Adult Diffuse Astrocytoma', 'Adult Ependymoma', 'Adult Giant Cell Glioblastoma', 'Adult Glioblastoma', 'Adult Gliosarcoma', 'Adult Mixed Glioma', 'Adult Myxopapillary Ependymoma', 'Adult Oligodendroglioma', 'Adult Pilocytic Astrocytoma', 'Adult Pineal Gland Astrocytoma', 'Adult Subependymal Giant Cell Astrocytoma', 'Adult Subependymoma']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.mayo.edu/research/clinical-trials', 'label': 'Mayo Clinic Clinical Trials'}]}, 'descriptionModule': {'briefSummary': 'RATIONALE: New imaging procedures, such as fluorine F 18 fluorodopa-labeled PET scan, may help in guiding surgery and radiation therapy and allow doctors to plan better treatment.\n\nPURPOSE: This clinical trial studies fluorine F 18 fluorodopa-labeled PET scan in planning surgery and radiation therapy in treating patients with newly diagnosed high- or low-grade malignant glioma', 'detailedDescription': 'PRIMARY OBJECTIVES:\n\nI. To determine correlation between 18F-FDOPA PET activity, MRI contrast enhancement, and high- or low-grade glioma biopsies.\n\nII. To compare radiotherapy target volume delineation with and without 18F- FDOPA-PET metabolic imaging information to determine role of metabolic imaging in radiotherapy treatment planning.\n\nSECONDARY OBJECTIVES:\n\nI. To determine correlation between concordance of 18F-FDOPA PET activity, MRI contrast enhancement, and high- or low-grade glioma biopsies and patient outcomes including overall survival and progression free survival.\n\nOUTLINE:\n\nBeginning at no more than 1 week before biopsy and resection, patients undergo fluorine F 18 fluorodopa-labeled PET/CT scan and pre-operative MRI. Patients then undergo stereotactic craniotomy. Some patients may also undergo radiation therapy.\n\nAfter completion of study treatment, patients are followed up every year for 5 years.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age ≥18 years.\n* MRI findings compatible with newly diagnosed high- or low-grade malignant glioma\n* Planned craniotomy and resection or biopsy\n* Willing to sign release of information for any radiation and/or follow-up records\n* Negative pregnancy test done =\\< 48 hours of injection of study drug, for women of childbearing potential only\n* Provide informed written consent\n* Patients with eGFR \\< 60 mg/min/1.72m2 are eligible for the study; PLEASE NOTE: the patient is not eligible to receive the contrast for the pMRI at the study dose.\n\nExclusion Criteria:\n\n* Unable to undergo MRI scans with contrast (e.g. cardiac pacemaker, defibrillator, kidney failure)\n* Unable to undergo an 18F-FDOPA PET scan (e.g. Parkinson's Disease, taking anti-dopaminergic, or dopamine agonist medication or less than 6 half-lives from discontinuance of dopamine agonists)\n* Pregnant women; nursing women; men or women of childbearing potential who are unwilling to employ adequate contraception"}, 'identificationModule': {'nctId': 'NCT01165632', 'briefTitle': 'Fluorine F 18 Fluorodopa-Labeled PET Scan in Planning Surgery and Radiation Therapy in Treating Patients With Newly Diagnosed High- or Low-Grade Malignant Glioma', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'A Pilot Study of Utility of 18F-FDOPA-PET for Neurosurgical Planning and Radiotherapy Target Delineation in Glioma Patients: Biopsy Validation of 18F-FDOPA-PET Uptake and Biodistribution in Brain Tumors', 'orgStudyIdInfo': {'id': 'MC1078'}, 'secondaryIdInfos': [{'id': 'NCI-2010-01607', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}, {'id': '10-001904', 'type': 'OTHER', 'domain': 'Mayo Clinic IRB'}, {'id': 'MC1078', 'type': 'OTHER', 'domain': 'Mayo Clinic Cancer Center'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm I', 'description': 'Beginning at no more than 1 week before biopsy or resection, patients undergo fluorine F 18 fluorodopa-labeled PET/CT scan and pre-operative MRI. Patients then undergo stereotactic craniotomy. Some patients may also undergo radiation therapy.', 'interventionNames': ['Procedure: biopsy', 'Procedure: computed tomography', 'Procedure: therapeutic conventional surgery', 'Radiation: radiation therapy treatment planning/simulation', 'Radiation: radiation therapy', 'Procedure: magnetic resonance imaging', 'Procedure: positron emission tomography', 'Drug: fluorine F 18 fluorodopa']}], 'interventions': [{'name': 'biopsy', 'type': 'PROCEDURE', 'otherNames': ['biopsies'], 'description': 'Correlative studies', 'armGroupLabels': ['Arm I']}, {'name': 'computed tomography', 'type': 'PROCEDURE', 'otherNames': ['tomography, computed'], 'description': 'Undergo computed tomography', 'armGroupLabels': ['Arm I']}, {'name': 'therapeutic conventional surgery', 'type': 'PROCEDURE', 'description': 'Undergo stereotactic craniotomy', 'armGroupLabels': ['Arm I']}, {'name': 'radiation therapy treatment planning/simulation', 'type': 'RADIATION', 'description': 'Undergo radiation therapy treatment planning/simulation', 'armGroupLabels': ['Arm I']}, {'name': 'radiation therapy', 'type': 'RADIATION', 'otherNames': ['irradiation', 'radiotherapy', 'therapy, radiation'], 'description': 'Undergo radiation therapy', 'armGroupLabels': ['Arm I']}, {'name': 'magnetic resonance imaging', 'type': 'PROCEDURE', 'otherNames': ['MRI', 'NMR imaging', 'NMRI', 'nuclear magnetic resonance imaging'], 'description': 'Undergo magnetic resonance imaging', 'armGroupLabels': ['Arm I']}, {'name': 'positron emission tomography', 'type': 'PROCEDURE', 'otherNames': ['FDG-PET', 'PET', 'PET scan', 'tomography, emission computed'], 'description': 'Undergo positron emission tomography', 'armGroupLabels': ['Arm I']}, {'name': 'fluorine F 18 fluorodopa', 'type': 'DRUG', 'otherNames': ['(18)F-FDOPA', '18F-6- L-fluorodopa', '18F-DOPA', '18F-FDOPA'], 'description': 'Given IV', 'armGroupLabels': ['Arm I']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}], 'overallOfficials': [{'name': 'Nadia N. Laack, M.D.', 'role': 'STUDY_CHAIR', 'affiliation': 'Mayo Clinic'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}