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Whole Body MRI to Identify Atypical Neurofibromas in Patients With NF1

NCT03820778 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2021-03-02

No results posted yet for this study

Summary

This study is being conducted to determine if Whole Body MRI (WBMRI) can be used to identify Atypical Neurofibromas (ANF) in Neurofibromatosis Type 1 (NF1) patients with high tumor burden. Each enrolled participant will have two (2) WBMRIs without sedation during the study period. Eligible participants must be Male or Female between the ages of 8-30 with diagnosed NF1; with one or more PN greater than 3cm in diameter and willing to comply with study procedures.

Conditions

  • Neurofibromatosis 1
  • Neurofibroma
  • Atypical Neurofibroma
  • Atypical Neurofibromatosis
  • Plexiform Neurofibroma
  • Von Recklinghausen Disease

Interventions

DIAGNOSTIC_TEST

Whole Body MRI

WBMRI with axial and coronal STIR (short inversion time inversion recovery) images + DWI (diffuse weighted imaging) will be performed and compared to regional MRI to assess value of this diagnostic test for the identification of suspicious looking lesions (i.e. diffuse nodular lesions or atypical plexiform neurofibroma)

Sponsors & Collaborators

  • Children's National Research Institute

    lead OTHER

Principal Investigators

  • Miriam Bornhorst, MD · Children's National Research Institute

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
8 Years
Max Age
30 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-07-12
Primary Completion
2020-08-01
Completion
2022-08-01
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03820778 on ClinicalTrials.gov