Ignite Creation Date:
2025-12-24 @ 10:00 PM
Ignite Modification Date:
2026-03-01 @ 11:27 AM
Study NCT ID:
NCT01800032
Status:
COMPLETED
Last Update Posted:
2021-05-12
First Post:
2013-02-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
PET/MRI in CNS and Extra-CNS Tumors of Patients With Neurofibromatosis-1 (NF1)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020339', 'term': 'Optic Nerve Glioma'}, {'id': 'D018318', 'term': 'Neurofibroma, Plexiform'}], 'ancestors': [{'id': 'D005910', 'term': 'Glioma'}, {'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': 'D019574', 'term': 'Optic Nerve Neoplasms'}, {'id': 'D003390', 'term': 'Cranial Nerve Neoplasms'}, {'id': 'D009423', 'term': 'Nervous System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D010524', 'term': 'Peripheral Nervous System Neoplasms'}, {'id': 'D003389', 'term': 'Cranial Nerve Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009901', 'term': 'Optic Nerve Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D009455', 'term': 'Neurofibroma'}, {'id': 'D018317', 'term': 'Nerve Sheath Neoplasms'}, {'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-01-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'completionDateStruct': {'date': '2019-12-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-05-11', 'studyFirstSubmitDate': '2013-02-25', 'studyFirstSubmitQcDate': '2013-02-25', 'lastUpdatePostDateStruct': {'date': '2021-05-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-02-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-12-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Plexiform Neurofibroma Cohort: Difference in FDG-avidity between progressive and non-progressive lesions', 'timeFrame': '12 months', 'description': 'Ratios of SUVmax values within a group of patients who all have progressive disease'}, {'measure': 'Optic Glioma Patients: Compare FDG-avidity between patients with progressive and non-progressive disease', 'timeFrame': '12 months'}], 'secondaryOutcomes': [{'measure': 'Report descriptive statistics for FDG-PET-MRI results', 'timeFrame': '0, 12 months', 'description': 'SUV max, tumor/brain uptake ratio, tumor/muscle uptake ratio'}, {'measure': 'Explore impact of FDG-PET-MRI surveillance on patient and family caregiver uncertainty and psychological distress', 'timeFrame': '0, 12 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Neurofibromatosis-1', 'Optic Glioma', 'Plexiform Neurofibroma']}, 'descriptionModule': {'briefSummary': 'This prospective pilot study is designed to provide preliminary data on the use of Fluorodeoxyglucose Positron Emission Tomography-Magnetic Resonance Imaging (FDG-PET-MRI) in patients with neurofibromatosis-1 (NF1) associated optic glioma and plexiform neurofibroma (PN).\n\nSubjects will undergo FDG-PET-MRI scans in place of standard of care imaging at 0 and 12 months, unless more frequent imaging is clinically indicated. Subjects and their family caregivers will also undergo serial interviews and complete questionnaires related to the psychosocial aspects of NF1.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '6 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'UNC Hospitals', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosed with neurofibromatosis-1 with either optic glioma, due for imaging scan, or plexiform neurofibroma, due for imaging secondary to clinical signs or symptoms of progressive disease\n* ≥ 6 years of age\n* English-speaking\n* If female of child-bearing potential, negative urine pregnancy test performed within 7 days prior to each FDG-PET-MRI\n* Study-specific informed consent or assent obtained and signed\n\nExclusion Criteria:\n\n* Unable to undergo FDG-PET-MRI without sedation\n* Currently undergoing chemotherapy for progressing optic glioma\n* Pregnant or lactating female\n* Poorly controlled diabetes mellitus\n* Presence of pacemaker, intracranial aneurysm clip, cochlear implant, metal halo device, epicardial pacemaker leads, or any other device that makes MRI unsafe\n* Serum creatinine \\> 1.8 mg/dL OR GFR \\< 30 mL/min\n* Unable to lie flat for \\> 1 hour\n* Body Mass Index (BMI) \\> 35'}, 'identificationModule': {'nctId': 'NCT01800032', 'briefTitle': 'PET/MRI in CNS and Extra-CNS Tumors of Patients With Neurofibromatosis-1 (NF1)', 'organization': {'class': 'OTHER', 'fullName': 'UNC Lineberger Comprehensive Cancer Center'}, 'officialTitle': 'Pilot Study of [18F] Fluorodeoxyglucose Positron Emission Tomography- Magnetic Resonance Imaging (FDG-PET-MRI) in CNS and Extra-CNS Tumors of Patients With Neurofibromatosis-1 (NF1)', 'orgStudyIdInfo': {'id': 'LCCC1222'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Plexiform Neurofibroma', 'description': 'NF1 associated plexiform neurofibroma'}, {'label': 'Optic Glioma', 'description': 'NF1 associated optic glioma'}]}, 'contactsLocationsModule': {'locations': [{'zip': '27599', 'city': 'Chapel Hill', 'state': 'North Carolina', 'country': 'United States', 'facility': 'University of North Carolina-Chapel Hill', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}], 'overallOfficials': [{'name': 'Timothy Gershon, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of North Carolina, Chapel Hill'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'UNC Lineberger Comprehensive Cancer Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}