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

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

• Registration Number: NCT01777451
• Lead Sponsor: Universitaire Ziekenhuizen KU Leuven

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

Detailed Description

Not available

Study Timeline

• Study Start: 2010-12
• Status Verified: 2013-01
• Primary Completion: 2013-01
• Study First Submitted: 2013-01-23
• Study First Submitted QC: 2013-01-23
• Last Update Submitted: 2013-01-23
• Study First Posted: 2013-01-28
• Last Update Posted: 2013-01-28
• Study Completion: 2014-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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.)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Neurofibromatosis 1	Additional imaging or surgery	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).

Primary Outcome Measures

Name	Time	Method
Estimation of total tumor load and diagnosis of high-risk neurofibromas	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

Name	Time	Method
To diagnose high-risk neurofibroma	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.

Trial Locations

Locations (1)

University Hospitals Leuven; 🇧🇪 Leuven, Belgium