Whole Body MRI for Neurofibromatosis

N/A

Waitlist Available

Led By Miriam Bornhorst, MD

Research Sponsored by Children's National Research Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3-4 years

Awards & highlights

No Placebo-Only Group

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.

Eligible Conditions

Neurofibromatosis
Benign Tumors
Plexiform Neurofibroma
Neurofibroma

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3-4 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3-4 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3-4 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Secondary study objectives

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

Other study objectives

Determine if the cfDNA levels correlate with presence of ANF.

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Study ArmExperimental Treatment1 Intervention

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Whole Body MRI

2007

N/A

~40

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