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

The recruitment status of this study is unknown because the information has not been verified recently.

Verified January 2013 by Universitaire Ziekenhuizen Leuven.
Recruitment status was Recruiting

Sponsor:

Information provided by (Responsible Party):

Steven Pans, Universitaire Ziekenhuizen Leuven

ClinicalTrials.gov Identifier:

NCT01777451

First received: January 23, 2013

Last updated: NA

Last verified: January 2013

History: No changes posted

Purpose

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


Study Type:	Observational
Study Design:	Observational Model: Case-Only Time Perspective: Prospective
Official Title:	Whole Body Magnetic Resonance Imaging With Diffusion Weighted Imaging : Potential Role in Neurofibromatosis

Resource links provided by NLM:

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 Neurofibroma Neurofibromatosis Type 1 Benign Schwannoma Malignant Peripheral Nerve Sheath Tumor Neurofibrosarcoma Carcinoid Tumor Neuroepithelioma Fibrosarcoma Malignant Mesenchymal Tumor Soft Tissue Sarcoma

U.S. FDA Resources

Further study details as provided by Universitaire Ziekenhuizen Leuven:

Primary Outcome Measures:

Estimation of total tumor load and diagnosis of high-risk neurofibromas [ Time Frame: 1 month ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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.


Estimated Enrollment:	30
Study Start Date:	December 2010
Estimated Study Completion Date:	January 2014
Estimated Primary Completion Date:	January 2013 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
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)

Eligibility


Ages Eligible for Study:	6 Years to 50 Years (Child, Adult)
Genders Eligible for Study:	Both
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received:	January 23, 2013
Last Updated:	January 23, 2013
Health Authority:	Belgium: Federal Agency for Medicinal Products and Health Products

Keywords provided by Universitaire Ziekenhuizen Leuven:


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

Additional relevant MeSH terms:


Neuroma Neurofibromatoses Neurofibroma Nerve Sheath Neoplasms Neurofibromatosis 1 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 Neoplasms Nervous System Neoplasms Peripheral Nervous System Diseases Neuromuscular Diseases Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Fibrosarcoma Neoplasms, Fibrous Tissue Neoplasms, Connective Tissue Neoplasms, Connective and Soft Tissue Sarcoma

ClinicalTrials.gov processed this record on September 23, 2016

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