Whole Body MRI to Identify Atypical Neurofibromas in Patients With NF1

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Brief Title

Whole Body MRI to Identify Atypical Neurofibromas in Patients With NF1

Official Title

Whole Body MRI to Identify Atypical Neurofibromas in Patients With NF1 and High Plexiform Neurofibroma Tumor Burden

Brief 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.
    

Detailed Description

      This is a study to determine the feasibility of using Whole Body MRI (WBMRI) to detect
      Atypical Plexiform Neurofibromas (ANF) among Neurofibromatosis Type 1 (NF1) patients who are
      at highest risk for developing these tumors. In order to do this, the investigators will
      prospectively obtain WBMRI scans on patients with high plexiform tumor burden (which
      investigators will define as >=1 plexiform neurofibroma (PN) that is >3cm in diameter on MRI)
      at the same time as their regularly scheduled MRI to allow for radiographic comparison of the
      identified PNs. In this study, the investigators will plan to establish a method that
      effectively characterizes PNs in terms of their volume, radiographic appearance on WBMRI and
      association with clinical characteristics.

      As an exploratory aim, the investigators plan to collect blood samples from each patient at
      the same time as the MRI to determine the feasibility of isolating cfDNA (circulating free
      DNA) from plasma of patients with high plexiform tumor burden.
    


Study Type

Interventional


Primary Outcome

To determine if WBMRI can be used to identify ANF in NF1 patients with high tumor burden.

Secondary Outcome

 Determine if clinical signs and symptoms correlate with tumor burden and/or the presence of ANF on WBMRI

Condition

Neurofibromatosis 1

Intervention

Whole Body MRI

Study Arms / Comparison Groups

 Study Arm
Description:  Whole Body MRI along with standard of care regional MRI and blood draw at enrollment followed by Whole Body MRI along with standard of care regional MRI and blood draw after 4-6 months.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Diagnostic Test

Estimated Enrollment

10

Start Date

July 12, 2018

Completion Date

August 1, 2022

Primary Completion Date

August 1, 2020

Eligibility Criteria

        Inclusion Criteria:

          1. Males or females between 8-30 years of age

          2. Confirmed diagnosis of NF1

          3. Stated willingness to comply with all study procedures and availability for the
             duration of the study

          4. Prior MRI documentation confirming >=1 PN that is >3cm in diameter

        Exclusion Criteria:

          1. Unable to undergo MRI without sedation

          2. Presence of metal or other devices that are contraindicated for MRI
      

Gender

All

Ages

8 Years - 30 Years

Accepts Healthy Volunteers

No

Contacts

Miriam Bornhorst, MD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT03820778

Organization ID

Pro00010431


Responsible Party

Principal Investigator

Study Sponsor

Children's National Research Institute


Study Sponsor

Miriam Bornhorst, MD, Principal Investigator, Children's National Health System


Verification Date

February 2021