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:
2025-12-24 @ 7:45 PM
Ignite Modification Date:
2025-12-24 @ 7:45 PM
NCT ID:
NCT05128903
Eligibility Criteria:
Inclusion Criteria
* Participant is at least 8 years of age
* Participants with histologically confirmed medulloblastoma and are scheduled to receive 36 Gy craniospinal irradiation
* Participant and/or guardian can understand and is willing to sign a written informed consent document according to institutional guidelines
* Subjects have either have high-affinity or mixed-affinity TSPO binding sites as determined by the single-nucleotide polymorphism (SNP) rs6971 in the TSPO gene.
Exclusion Criteria:
* Participants with a large pseudomeningocele (\>4 cm in size) at the surgical site, complications from ventricular access (evidenced by hemorrhage and/or enhancement along the catheter), large subdural effusion in the supra-tentorial compartment (\>1 cm in the maximum transverse dimension). All of these are expected to induce inflammation.
* Female participants of childbearing age must not be lactating due to theoretical potential harm to the infant from exposure to radiation.
* Subjects with low-affinity TSPO binding sites as determined by the single-nucleotide polymorphism (SNP) rs6971 in the TSPO gene.
* Pregnant subjects.
* Patients needing sedation for the PET scans or optional MRI scans.
* Participants with a diagnosis of recurrent medulloblastoma.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
8 Years
Maximum Age:
39 Years
Study:
NCT05128903
Study Brief:
Protocol Section:
NCT05128903