NCT01777451|Unknown
Whole Body Magnetic Resonance Imaging With Diffusion Weighted Imaging : Potential Role in Neurofibromatosis
NEFIMAR
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NEFIMAR
Sponsor study identifier
Secondary identifiers
OTHER · Clinicla trial Center UZ Leuven
observational
30
1 country
1
Study Start
December 2010
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
January 2013
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
January 2014
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 2014
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 2010
Date type not reportedThis date has not been verified as actual or estimated.
January 2013
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
January 23, 2013
Actual (reported)January 28, 2013
Actual (reported)January 2014
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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
To diagnose high-risk neurofibroma
2 months
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).
No specific intervention is necessary. If a suspicious lesion is diagnosed on MRI, further investigation will be planned (PET-CT or surgery - biopsy)
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
All patients with a clinically proven neurofibromatosis type 1 can be included.
University Hospitals Leuven
Leuven, Belgium
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.
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.
Steven Pans, MD
Universitaire Ziekenhuizen KU Leuven
First Submitted
January 23, 2013
First Posted
January 28, 2013
Study Start
December 2010
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
January 2013
Use of RAD001 as Monotherapy in the Treatment of Neurofibromatosis 1 Related Internal Plexiform Neurofibromas
Contact the study team to confirm eligibility.
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.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
January 2014
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
January 28, 2013
Record last verified: 2013-01
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