Whole Body Magnetic Resonance Imaging With Diffusion Weighted Imaging : Potential Role in Neurofibromatosis (NEFIMAR)

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ClinicalTrials.gov Identifier: NCT01777451

Recruitment Status : Unknown

Verified January 2013 by Steven Pans, Universitaire Ziekenhuizen Leuven.
Recruitment status was: Recruiting

First Posted : January 28, 2013

Last Update Posted : January 28, 2013

Sponsor:

Information provided by (Responsible Party):

Steven Pans, Universitaire Ziekenhuizen Leuven

Study Description

Brief Summary:

Whole body MRI will be performed in patients with neurofibromatosis Type 1

PURPOSE 1:

To 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.

PURPOSE 2: added value of diffusion weighted imaging in diagnosis of high-risk neurofibromas

PURPOSE 3 : to determine the apparent diffusion coefficient of the malignant nerve sheath tumors and neurofibroma.

PURPOSE 4 : correlation between histopathology of the surgically resected neurofibroma/malignant nerve sheath tumors and MRI findings

Condition or disease	Intervention/treatment
Whole Body Imaging Magnetic Resonance Imaging Neurofibromatosis 1 Diffusion Magnetic Resonance Imaging Peripheral Nerve Sheath Tumors, Malignant	Other: Additional imaging or surgery

Study Design


Study Type :	Observational
Estimated Enrollment :	30 participants
Observational Model:	Case-Only
Time Perspective:	Prospective
Official Title:	Whole Body Magnetic Resonance Imaging With Diffusion Weighted Imaging : Potential Role in Neurofibromatosis
Study Start Date :	December 2010
Estimated Primary Completion Date :	January 2013
Estimated Study Completion Date :	January 2014

Resource links provided by the National Library of Medicine

Genetics Home Reference related topics: Neurofibromatosis type 1 Neurofibromatosis type 2

MedlinePlus related topics: Diagnostic Imaging MRI Scans Neurofibromatosis

Genetic and Rare Diseases Information Center resources: Neurofibromatosis Neurofibromatosis Type 1 Neurofibroma Schwannoma Malignant Peripheral Nerve Sheath Tumor Neurofibrosarcoma Neuroendocrine Tumor Neuroepithelioma Fibrosarcoma Soft Tissue Sarcoma

U.S. FDA Resources

Groups and Cohorts

Group/Cohort	Intervention/treatment
Neurofibromatosis 1 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 ) GROUP 2: No suspicious lesions at MRI. Follow-up within 2 years(Study MRI).	Other: Additional imaging or surgery No specific intervention is necessary. If a suspicious lesion is diagnosed on MRI, further investigation will be planned (PET-CT or surgery - biopsy)

Outcome Measures

Primary Outcome Measures :

Estimation of total tumor load and diagnosis of high-risk neurofibromas [ Time Frame: 1 month ]
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.

Secondary Outcome Measures :

To diagnose high-risk neurofibroma [ Time Frame: 2 months ]
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.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	6 Years to 50 Years (Child, Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

All patients with a clinically proven neurofibromatosis type 1 can be included.

Criteria

Inclusion Criteria:

Patients with neurofibromatosis type 1, between 6 and 50 years old

Exclusion Criteria:

Patients who are not allowed to be scanned on MRI (contra-indications: pacemaker ed.)

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01777451

Contacts


Contact: Steven Pans, MD	3216340505s	steven.pans@uzleuven.be

Locations


Belgium
University Hospitals Leuven	Recruiting
Leuven, Belgium
Contact: Steven Pans, MD 3216340505 steven.pans@uzleuven.be

Sponsors and Collaborators

Universitaire Ziekenhuizen Leuven

Investigators


Principal Investigator:	Steven Pans, MD	Universitaire Ziekenhuizen Leuven

More Information

Publications:

Tucker T, Friedman JM, Friedrich RE, Wenzel R, Fünsterer 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.

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.

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.


Responsible Party:	Steven Pans, Medical Doctor Radiologist, Universitaire Ziekenhuizen Leuven
ClinicalTrials.gov Identifier:	NCT01777451 History of Changes
Other Study ID Numbers:	NEFIMAR S52684 ( Other Identifier: Clinicla trial Center UZ Leuven )
First Posted:	January 28, 2013 Key Record Dates
Last Update Posted:	January 28, 2013
Last Verified:	January 2013

Keywords provided by Steven Pans, Universitaire Ziekenhuizen Leuven:


Whole Body Imaging Magnetic Resonance Imaging Neurofibromatosis 1 Diffusion Magnetic Resonance Imaging Peripheral Nerve Sheath Tumors, Malignant

Additional relevant MeSH terms:


Neurofibromatoses Neurofibromatosis 1 Neurofibroma Nerve Sheath Neoplasms Neurilemmoma Neurofibrosarcoma Neoplasms, Nerve Tissue Neoplasms by Histologic Type Neoplasms Neoplastic Syndromes, Hereditary Neurocutaneous Syndromes Nervous System Diseases Heredodegenerative Disorders, Nervous System Neurodegenerative Diseases	Genetic Diseases, Inborn Peripheral Nervous System Diseases Neuromuscular Diseases Peripheral Nervous System Neoplasms Nervous System Neoplasms Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neuroma Fibrosarcoma Neoplasms, Fibrous Tissue Neoplasms, Connective Tissue Neoplasms, Connective and Soft Tissue Sarcoma

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