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ACTIVE NOT RECRUITING
NCT05677594

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

Sponsor: Johns Hopkins University

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

6 Years - Any

Study Type

OBSERVATIONAL

Enrollment

80

Start Date

2021-07-01

Completion Date

2028-06-30

Last Updated

2026-01-12

Healthy Volunteers

No

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

Locations (1)

Johns Hopkins University

Baltimore, Maryland, United States