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New study aims to predict cancer risk in NF1 patients before it strikes

NCT ID NCT05677594

Knowledge-focused Sponsor: Johns Hopkins University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study follows 80 people with Neurofibromatosis type 1 (NF1) who are at high risk for developing malignant peripheral nerve sheath tumors (MPNST). Researchers will use yearly whole-body MRI scans, blood samples, and checkups to track changes in nerve lesions over time. The goal is to find imaging or genetic clues that could predict which patients are most likely to develop cancer, so doctors can catch it earlier.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

80 people

The number who actually took part.

Started

Jul 2021

Expected to finish

Jun 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

High risk persons with NF1 based on genetic testing (microdeletion, family/personal history of atypical NF, ANNUBP, MPNST, prior radiation treatment, large plexiform neurofibroma burden)

Ages

6 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: Inclusion criteria are person (age \> 6 years) with clinical diagnosis of NF1, ability to undergo whole body MRI without intravenous contrast material considered "high-risk" for MPNST. The term "high risk" is defined as: * high pNF burden defined as 1 pNF \> 3 cm or \> 1 pNF * diagnosis of whole-gene deletion ("microdeletion") of the NF1 gene on genetic testing * prior history of atypical or malignant PNST * family or personal history of MPNST or atypical PNST * prior radiation treatment Exclusion Criteria: * Pregnancy * inability to tolerate MRI or 18F-FDG-PET/CT imaging without anesthesia * ongoing NF1-related intervention (including systemic steroids) or therapy that may alter the anatomic, metabolic or functional MRI appearance of the PNSTs.

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Conditions

The condition(s) this trial relates to.

atypical neurofibroma disease malignant peripheral nerve sheath tumor neurofibromatosis type 1 neurofibrosarcoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Atypical neurofibroma Malignant peripheral nerve sheath tumor (MPNST) of soft tissue (diagnosis) Neurofibromatosis 1

Contacts and locations

Locations

  • Johns Hopkins University

    Baltimore, Maryland, 21287, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.