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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
Sponsor:
Information provided by (Responsible Party):

Study Description
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


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 Design

Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Case-Only
Time Perspective: Prospective
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


Groups and Cohorts

Group/Cohort Intervention/treatment
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)


Outcome Measures

Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 50 Years   (Child, Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

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


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 ( Other Identifier: Clinicla trial Center UZ Leuven )
First Posted: January 28, 2013    Key Record Dates
Last Update Posted: January 28, 2013
Last Verified: January 2013

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