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Multi-parametric Biomarker Development to Predict Malignant Conversion in Patients With Neurofibromatosis Type 1

NCT05677594 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 80

Last updated 2026-01-12

No results posted yet for this study

Summary

The goal of this prospective observational study is to learn about the utility of imaging and clinical features in patients with Neurofibromatosis type 1 categorized as high risk for the development of malignant peripheral nerve sheath tumors.

The main objectives are:

* To evaluate the prevalence, multi-parametric imaging features of distinct nodular lesions ("DNLs") and natural history in people with NF1 with clinical and genetic features deemed "high-risk" for malignancy.
* To assess the relationship between individual clinical, genetic and imaging factors that have been suggested to be risk factors for malignant peripheral nerve sheath tumors (MPNST) and the confirmation of atypical neurofibromas (aNF)/ atypical neurofibromatous neoplasm of unknown biologic potential (ANNUBP) or MPNST on pathology.

In this research study, the participants will be asked to undergo whole body MRI, provide blood sample and clinical evaluation annually.

Conditions

  • Neurofibromatosis 1
  • Malignant Peripheral Nerve Sheath Tumor (MPNST) of Soft Tissue (Diagnosis)
  • Atypical Neurofibroma

Interventions

DIAGNOSTIC_TEST

Whole Body Magnetic Resonance Imaging

Magnetic resonance imaging of the entire body from skull base through distal thighs/knees without contrast material

Sponsors & Collaborators

Principal Investigators

  • Shivani Ahlawat, PhD · Johns Hopkins School of Medicine

Eligibility

Min Age
6 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-07-01
Primary Completion
2028-06-30
Completion
2028-06-30

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 NCT05677594 on ClinicalTrials.gov