Ignite Creation Date:
2025-12-24 @ 11:41 PM
Ignite Modification Date:
2026-01-01 @ 12:03 AM
Study NCT ID:
NCT01777451
Status:
UNKNOWN
Last Update Posted:
2013-01-28
First Post:
2013-01-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Whole Body Magnetic Resonance Imaging With Diffusion Weighted Imaging : Potential Role in Neurofibromatosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009456', 'term': 'Neurofibromatosis 1'}, {'id': 'D018319', 'term': 'Neurofibrosarcoma'}], 'ancestors': [{'id': 'D017253', 'term': 'Neurofibromatoses'}, {'id': 'D009455', 'term': 'Neurofibroma'}, {'id': 'D018317', 'term': 'Nerve Sheath Neoplasms'}, {'id': 'D009380', 'term': 'Neoplasms, Nerve Tissue'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D009386', 'term': 'Neoplastic Syndromes, Hereditary'}, {'id': 'D020752', 'term': 'Neurocutaneous Syndromes'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D020271', 'term': 'Heredodegenerative Disorders, Nervous System'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D010523', 'term': 'Peripheral Nervous System Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D005354', 'term': 'Fibrosarcoma'}, {'id': 'D018218', 'term': 'Neoplasms, Fibrous Tissue'}, {'id': 'D009372', 'term': 'Neoplasms, Connective Tissue'}, {'id': 'D018204', 'term': 'Neoplasms, Connective and Soft Tissue'}, {'id': 'D012509', 'term': 'Sarcoma'}, {'id': 'D010524', 'term': 'Peripheral Nervous System Neoplasms'}, {'id': 'D009423', 'term': 'Nervous System Neoplasms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2010-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-01', 'completionDateStruct': {'date': '2014-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2013-01-23', 'studyFirstSubmitDate': '2013-01-23', 'studyFirstSubmitQcDate': '2013-01-23', 'lastUpdatePostDateStruct': {'date': '2013-01-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-01-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Estimation of total tumor load and diagnosis of high-risk neurofibromas', 'timeFrame': '1 month', 'description': 'Estimation of the total tumor load of neurofibromas with whole body MRI (head to knee). Diagnosis of high risk neurofibroma in the chest, abdomen, pelvis, and extremities with T2-weighted sequence and diffusion weighted sequence.'}], 'secondaryOutcomes': [{'measure': 'To diagnose high-risk neurofibroma', 'timeFrame': '2 months', 'description': 'Some patients with neurofibromatosis have lesions, pre-malignant or malignant neurofibromas. Additional imaging (PET-CT), a biopsy or surgical treatment is necessary in combination with histopathology of the lesion.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Whole Body Imaging', 'Magnetic Resonance Imaging', 'Neurofibromatosis 1', 'Diffusion Magnetic Resonance Imaging', 'Peripheral Nerve Sheath Tumors, Malignant'], 'conditions': ['Whole Body Imaging', 'Magnetic Resonance Imaging', 'Neurofibromatosis 1', 'Diffusion Magnetic Resonance Imaging', 'Peripheral Nerve Sheath Tumors, Malignant']}, 'referencesModule': {'references': [{'pmid': '18930997', 'type': 'BACKGROUND', 'citation': 'Tucker T, Friedman JM, Friedrich RE, Wenzel R, Funsterer C, Mautner VF. Longitudinal study of neurofibromatosis 1 associated plexiform neurofibromas. J Med Genet. 2009 Feb;46(2):81-5. doi: 10.1136/jmg.2008.061051. Epub 2008 Oct 17.'}, {'pmid': '19244040', 'type': 'BACKGROUND', 'citation': 'Cai W, Kassarjian A, Bredella MA, Harris GJ, Yoshida H, Mautner VF, Wenzel R, Plotkin SR. Tumor burden in patients with neurofibromatosis types 1 and 2 and schwannomatosis: determination on whole-body MR images. Radiology. 2009 Mar;250(3):665-73. doi: 10.1148/radiol.2503080700.'}, {'pmid': '19091504', 'type': 'BACKGROUND', 'citation': 'Van Meerbeeck SF, Verstraete KL, Janssens S, Mortier G. Whole body MR imaging in neurofibromatosis type 1. Eur J Radiol. 2009 Feb;69(2):236-42. doi: 10.1016/j.ejrad.2008.10.024. Epub 2008 Dec 16.'}]}, 'descriptionModule': {'briefSummary': 'Whole body MRI will be performed in patients with neurofibromatosis Type 1\n\nPURPOSE 1:\n\nTo determine the total tumor load (neurofibroma) and to diagnose plexiform neurofibromas or malignant peripheral nerve sheath tumors. All patients will be scanned two years after the baseline whole body MRI to investigate to investigate the changes of total tumor load.\n\nPURPOSE 2: added value of diffusion weighted imaging in diagnosis of high-risk neurofibromas\n\nPURPOSE 3 : to determine the apparent diffusion coefficient of the malignant nerve sheath tumors and neurofibroma.\n\nPURPOSE 4 : correlation between histopathology of the surgically resected neurofibroma/malignant nerve sheath tumors and MRI findings'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '50 Years', 'minimumAge': '6 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All patients with a clinically proven neurofibromatosis type 1 can be included.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with neurofibromatosis type 1, between 6 and 50 years old\n\nExclusion Criteria:\n\n* Patients who are not allowed to be scanned on MRI (contra-indications: pacemaker ed.)'}, 'identificationModule': {'nctId': 'NCT01777451', 'acronym': 'NEFIMAR', 'briefTitle': 'Whole Body Magnetic Resonance Imaging With Diffusion Weighted Imaging : Potential Role in Neurofibromatosis', 'organization': {'class': 'OTHER', 'fullName': 'Universitaire Ziekenhuizen KU Leuven'}, 'officialTitle': 'Whole Body Magnetic Resonance Imaging With Diffusion Weighted Imaging : Potential Role in Neurofibromatosis', 'orgStudyIdInfo': {'id': 'NEFIMAR'}, 'secondaryIdInfos': [{'id': 'S52684', 'type': 'OTHER', 'domain': 'Clinicla trial Center UZ Leuven'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Neurofibromatosis 1', 'description': 'All patients diagnosed with neurofibromatosis type 1. GROUP 1:ADDITIONAL IMAGING OR SURGERY There will be patients with high-risk neurofibromas (potential malignant). These patients will underwent additional examinations or surgery (outside this study). Follow-up MRI within 2 years (study MRI )\n\nGROUP 2:\n\nNo suspicious lesions at MRI. Follow-up within 2 years(Study MRI).', 'interventionNames': ['Other: Additional imaging or surgery']}], 'interventions': [{'name': 'Additional imaging or surgery', 'type': 'OTHER', 'description': 'No specific intervention is necessary. If a suspicious lesion is diagnosed on MRI, further investigation will be planned (PET-CT or surgery - biopsy)', 'armGroupLabels': ['Neurofibromatosis 1']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Leuven', 'status': 'RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'Steven Pans, MD', 'role': 'CONTACT', 'email': 'steven.pans@uzleuven.be', 'phone': '3216340505'}], 'facility': 'University Hospitals Leuven', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}], 'centralContacts': [{'name': 'Steven Pans, MD', 'role': 'CONTACT', 'email': 'steven.pans@uzleuven.be', 'phone': '3216340505s'}], 'overallOfficials': [{'name': 'Steven Pans, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universitaire Ziekenhuizen KU Leuven'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universitaire Ziekenhuizen KU Leuven', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Medical Doctor Radiologist', 'investigatorFullName': 'Steven Pans', 'investigatorAffiliation': 'Universitaire Ziekenhuizen KU Leuven'}}}}