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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2013 by Universitaire Ziekenhuizen Leuven
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:


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
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:
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:
Neurofibromatoses
Neurofibromatosis 1
Nerve Sheath Neoplasms
Neurilemmoma
Neurofibrosarcoma
Fibrosarcoma
Genetic Diseases, Inborn
Heredodegenerative Disorders, Nervous System
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Connective and Soft Tissue
Neoplasms, Connective Tissue
Neoplasms, Fibrous Tissue
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Neoplastic Syndromes, Hereditary
Nervous System Diseases
Nervous System Neoplasms
Neurocutaneous Syndromes
Neurodegenerative Diseases
Neuroectodermal Tumors
Neuroendocrine Tumors
Neurofibroma
Neuroma
Neuromuscular Diseases
Peripheral Nervous System Diseases
Peripheral Nervous System Neoplasms
Sarcoma

ClinicalTrials.gov processed this record on October 29, 2014