Ignite Creation Date:
2025-12-25 @ 4:07 AM
Ignite Modification Date:
2026-04-15 @ 10:31 AM
Study NCT ID:
NCT02020720
Status:
COMPLETED
Last Update Posted:
2025-01-23
First Post:
2013-12-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
18F-DOPA-PET in Planning Surgery in Patients With Gliomas
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005910', 'term': 'Glioma'}, {'id': 'D001932', 'term': 'Brain Neoplasms'}], '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'}, {'id': 'D016543', 'term': 'Central Nervous System Neoplasms'}, {'id': 'D009423', 'term': 'Nervous System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001706', 'term': 'Biopsy'}, {'id': 'C043437', 'term': 'fluorodopa F 18'}, {'id': 'D009682', 'term': 'Magnetic Resonance Spectroscopy'}], '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': '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': 72}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-01-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2024-01-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-21', 'studyFirstSubmitDate': '2013-12-19', 'studyFirstSubmitQcDate': '2013-12-19', 'lastUpdatePostDateStruct': {'date': '2025-01-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-12-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-10-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Accurate identification of the highest grade/highest density disease', 'timeFrame': 'Up to 5 years', 'description': 'Paired t-test statistical analysis will be used to evaluate differences in volumes identified using biopsy-validated thresholds as highly aggressive disease comparing 18F-DOPA uptake and relative cerebral blood volume from pMRI.'}, {'measure': 'Accurate identification of tumor extent', 'timeFrame': 'Up to 5 years', 'description': 'Paired t-test statistical analysis will be used to evaluate differences in volumes identified using biopsy-validated thresholds as disease extent comparing 18F-DOPA PET and diffusion maps from DTI.'}, {'measure': 'Role of metabolic imaging in neurosurgical resection planning', 'timeFrame': 'Up to 5 years', 'description': 'Paired t-test analysis will be performed to determine the level of statistical significance between conventional MRI only and PET + MRI volumes.'}], 'primaryOutcomes': [{'measure': 'Ratios of maximum tumor standardized uptake value (SUVmax) normalized to mean SUV (SUVmean) of T/N', 'timeFrame': 'Up to 1 year', 'description': "To determine the optimal PET threshold for distinguishing HGG from LGG brain tissue, receiver operating characteristic (ROC) analysis and the Youden's index (sum of the sensitivity and specificity - 1) will be used. The Youden's index will be calculated for each possible T/N threshold. The final ROC area under the curve (AUC) value and confidence intervals will be estimated using ROC analysis methods for clustered continuous data as described by Obychowski."}], 'secondaryOutcomes': [{'measure': 'Differences in volumes generated from biopsy-validated thresholds evaluated by 18F-DOPA-PET, pMRI, and DTI', 'timeFrame': 'Up to 5 years', 'description': 'Paired t-test statistical analysis will be performed to determine if any differences exist and the level of statistical significance between volumes.'}, {'measure': 'Histologic grade of the specimen defined as HGG, LGG, or non-malignant brain tissue', 'timeFrame': 'Up to 5 years', 'description': 'The relationship between these T/N values, MRI contrast enhancement values, and the histologic grade of the specimen (HGG, LGG, or non-malignant brain tissue) will be determined using multivariate linear regression. These models will also include as appropriate the specimen cellularity and necrosis values.'}, {'measure': 'MRI contrast enhancement values', 'timeFrame': 'Up to 5 years', 'description': 'The relationship between these T/N values, MRI contrast enhancement values, and the histologic grade of the specimen (HGG, LGG, or non-malignant brain tissue) will be determined using multivariate linear regression. These models will also include as appropriate the specimen cellularity and necrosis values.'}, {'measure': 'Progression free survival', 'timeFrame': 'The time from study entry to progression, assessed up to 5 years'}, {'measure': 'Proportion of patients whose maximum 18F-DOPA uptake samples are in agreement with the final diagnostic grade', 'timeFrame': 'Up to 5 years', 'description': 'Associated confidence intervals will be estimated based on dividing the number of patients whose samples agree by the total number of patients.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Malignant Glioma', 'Recurrent Brain Neoplasm']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.mayo.edu/research/clinical-trials', 'label': 'Mayo Clinic Clinical Trials'}]}, 'descriptionModule': {'briefSummary': 'This pilot clinical trial studies fluorine F 18 fluorodopa (18F-DOPA)-positron emission tomography (PET) in planning surgery in patients with gliomas. New imaging procedures, such as 18F-DOPA-PET scan, may help find gliomas and may help in planning surgery.', 'detailedDescription': 'PRIMARY OBJECTIVES:\n\nI. Accurately define a standardized 18F-DOPA PET tumor/normal tissue (T/N) threshold to delineate high grade gliomas (HGG) from low grade gliomas (LGG).\n\nSECONDARY OBJECTIVES:\n\nI. Determine correlation between 18F-DOPA PET activity, magnetic resonance imaging (MRI) contrast enhancement and high- or low-grade glioma biopsies.\n\nII. Compare grade from maximum 18F-DOPA uptake samples for all resection patients against the final diagnostic grade, based on the highest grade component from all stereotactic and non-stereotactic samples acquired for open resection patients.\n\nIII. Compare volume differences between 18F-DOPA PET activity, MRI contrast enhancement, perfusion MRI (pMRI), and diffusion tensor imaging (DTI) for neurosurgical planning.\n\nIV. Assess the time to progression for patients receiving resections and biopsies only.\n\nTERTIARY OBJECTIVES:\n\nI. Compare histopathology correlations with 18F-DOPA PET against correlations with perfusion MR imaging for accurate identification of the highest grade/highest density disease.\n\nII. Compare histopathology correlations with 18F-DOPA PET against correlations with diffusion tensor imaging information for accurate identification of tumor extent.\n\nIII. Compare neurosurgical resection extent volume delineation with and without 18F-FDOPA-PET metabolic imaging information to determine role of metabolic imaging in neurosurgical resection planning.\n\nOUTLINE:\n\nWithin 1 week of biopsy or resection, patients undergo 18F-DOPA PET/computed tomography (CT) scan and pMRI and DTI at baseline. Patients then undergo stereotactic craniotomy or image-guided biopsy.\n\nAfter completion of study treatment, patients are followed up yearly for 5 years.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '7 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* MRI findings compatible with newly diagnosed or recurrent 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* Provide informed written consent if \\>= 18 years; if \\< 18 years, provide informed written assent and parent or legal guardian provide informed written consent\n* Ability to provide tissue for mandatory correlative research component\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-DOPA 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; NOTE: other potentially interfering drugs: amoxapine, amphetamine, benztropine, buproprion, buspirone, cocaine, mazindol, methamphetamine, methylphenidate, norephedrine, phentermine, phenylpropanolamine, selegiline, paroxetine, citalopram, and sertraline; if a patient is on any of these drugs, list which ones on the on-study form\n* Any of the following:\n\n * Pregnant women\n * Nursing women\n * Men or women of childbearing potential who are unwilling to employ adequate contraception"}, 'identificationModule': {'nctId': 'NCT02020720', 'briefTitle': '18F-DOPA-PET in Planning Surgery in Patients With Gliomas', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'Evaluating the Impact of 18F-DOPA-PET on Neurosurgical Planning for Gliomas', 'orgStudyIdInfo': {'id': 'MC1373'}, 'secondaryIdInfos': [{'id': 'P50CA108961', 'link': 'https://reporter.nih.gov/quickSearch/P50CA108961', 'type': 'NIH'}, {'id': 'R01CA178200', 'link': 'https://reporter.nih.gov/quickSearch/R01CA178200', 'type': 'NIH'}, {'id': 'NCI-2013-02373', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}, {'id': 'MC1373', 'type': 'OTHER', 'domain': 'Mayo Clinic'}, {'id': '13-005102', 'type': 'OTHER', 'domain': 'Mayo Clinic Institutional Review Board'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Diagnostic (18F-DOPA-PET)', 'description': 'Within 1 week of biopsy or resection, patients undergo 18F-DOPA PET/CT scan and pMRI and DTI at baseline. Patients then undergo stereotactic craniotomy or image-guided biopsy.', 'interventionNames': ['Procedure: Biopsy', 'Procedure: Computed Tomography', 'Procedure: Diffusion Weighted Imaging', 'Drug: Fluorine F 18 Fluorodopa', 'Other: Laboratory Biomarker Analysis', 'Procedure: Perfusion Magnetic Resonance Imaging', 'Procedure: Positron Emission Tomography', 'Procedure: Therapeutic Conventional Surgery']}], 'interventions': [{'name': 'Biopsy', 'type': 'PROCEDURE', 'otherNames': ['Bx'], 'description': 'Undergo image-guided biopsy', 'armGroupLabels': ['Diagnostic (18F-DOPA-PET)']}, {'name': 'Computed Tomography', 'type': 'PROCEDURE', 'otherNames': ['CAT', 'CAT Scan', 'Computerized Axial Tomography', 'Computerized Tomography', 'CT', 'CT SCAN', 'tomography'], 'description': 'Undergo 18F-DOPA-PET/CT', 'armGroupLabels': ['Diagnostic (18F-DOPA-PET)']}, {'name': 'Diffusion Weighted Imaging', 'type': 'PROCEDURE', 'otherNames': ['Diffusion Weighted MRI', 'Diffusion-Weighted Magnetic Resonance Imaging', 'Diffusion-Weighted MR Imaging', 'Diffusion-Weighted MRI', 'DWI', 'DWI MRI', 'DWI-MRI', 'MR Diffusion-Weighted Imaging'], 'description': 'Undergo DTI', 'armGroupLabels': ['Diagnostic (18F-DOPA-PET)']}, {'name': 'Fluorine F 18 Fluorodopa', 'type': 'DRUG', 'otherNames': ['18F-FDOPA'], 'description': 'Undergo 18F-DOPA-PET/CT', 'armGroupLabels': ['Diagnostic (18F-DOPA-PET)']}, {'name': 'Laboratory Biomarker Analysis', 'type': 'OTHER', 'description': 'Correlative studies', 'armGroupLabels': ['Diagnostic (18F-DOPA-PET)']}, {'name': 'Perfusion Magnetic Resonance Imaging', 'type': 'PROCEDURE', 'otherNames': ['magnetic resonance perfusion imaging'], 'description': 'Undergo pMRI', 'armGroupLabels': ['Diagnostic (18F-DOPA-PET)']}, {'name': 'Positron Emission Tomography', 'type': 'PROCEDURE', 'otherNames': ['Medical Imaging, Positron Emission Tomography', 'PET', 'PET SCAN', 'Positron Emission Tomography Scan', 'Positron-Emission Tomography', 'proton magnetic resonance spectroscopic imaging'], 'description': 'Undergo 18F-DOPA-PET/CT', 'armGroupLabels': ['Diagnostic (18F-DOPA-PET)']}, {'name': 'Therapeutic Conventional Surgery', 'type': 'PROCEDURE', 'description': 'Undergo stereotactic craniotomy', 'armGroupLabels': ['Diagnostic (18F-DOPA-PET)']}]}, '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': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic in Rochester'}, {'name': 'Debra H. Brinkmann, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic in Rochester'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}