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

NCT01777451 | Unknown

• 2 other identifiers: NEFIMARS52684
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Estimation of total tumor load and diagnosis of high-risk neurofibromas

  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.

  1 month

Secondary Outcomes (1)

• To diagnose high-risk neurofibroma

  2 months

Study Arms (1)

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

Interventions

Additional imaging or surgery OTHER

No specific intervention is necessary. If a suspicious lesion is diagnosed on MRI, further investigation will be planned (PET-CT or surgery - biopsy)

Neurofibromatosis 1

Eligibility Criteria

• Age: 6 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead

Study Sites (1)

University Hospitals Leuven

Leuven, Belgium

RECRUITING

Related Publications (3)

• 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: 18930997 BACKGROUND

• 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: 19244040 BACKGROUND

• 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.

  PMID: 19091504 BACKGROUND

MeSH Terms

Conditions

Neurofibromatosis 1; Neurofibrosarcoma

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Neurofibromatoses; Neurofibroma; Nerve Sheath Neoplasms; Neoplasms, Nerve Tissue; Neoplasms by Histologic Type; Neoplasms; Neoplastic Syndromes, Hereditary; Neurocutaneous Syndromes; Nervous System Diseases; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Peripheral Nervous System Diseases; Neuromuscular Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Fibrosarcoma; Neoplasms, Fibrous Tissue; Neoplasms, Connective Tissue; Neoplasms, Connective and Soft Tissue; Sarcoma; Peripheral Nervous System Neoplasms; Nervous System Neoplasms

Study Officials

• Steven Pans, MD

  Universitaire Ziekenhuizen KU Leuven

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Steven Pans, MD

CONTACT

3216340505s; steven.pans@uzleuven.be

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor Radiologist

Study Record Dates

• First Submitted: January 23, 2013
• First Posted: January 28, 2013
• Study Start: December 1, 2010
• Primary Completion: January 1, 2013
• Study Completion: January 1, 2014
• Last Updated: January 28, 2013

Record last verified: 2013-01

Locations

BE (1)