Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:31 AM
Ignite Modification Date:
2025-12-25 @ 1:31 AM
NCT ID:
NCT05677594
Eligibility Criteria:
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
6 Years
Study:
NCT05677594
Study Brief:
Protocol Section:
NCT05677594