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
Whole body MRI will be performed in patients with neurofibromatosis Type 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 Type :||Observational|
|Estimated Enrollment :||30 participants|
|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|
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 )
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)
- 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.
- 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.
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
|Contact: Steven Pans, MDfirstname.lastname@example.org|
|University Hospitals Leuven||Recruiting|
|Contact: Steven Pans, MD 3216340505 email@example.com|
|Principal Investigator:||Steven Pans, MD||Universitaire Ziekenhuizen Leuven|