NCT05677594Active, not recruiting
Multi-parametric Biomarker Development to Predict Malignant Conversion in Patients With Neurofibromatosis Type 1
Source: ClinicalTrials.gov · Last updated 12 Jan 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 80 (actual)
- First submitted
- 9 Dec 2022
- Start date
- 1 Jul 2021
- Primary completion date
- 30 Jun 2028
- Lead sponsor
- Johns Hopkins University
- Diseases
- Childhood cancers, Sarcoma
- NCT number
- NCT05677594
What you commit to
- Study type: Observational
- Participants enrolled: 80
- From 1 Jul 2021 to the primary completion date, 30 Jun 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- ongoing NF1-related intervention (including systemic steroids) or therapy that may alter the anatomic, metabolic or functional MRI appearance of the PNSTs.
Other
- Pregnancy
- inability to tolerate MRI or 18F-FDG-PET/CT imaging without anesthesia
Who the study is looking for
- 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
Age in the registry: 6 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Johns Hopkins University Coordinator of this site? Confirm its status | Baltimore | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.