MedPath

Quantitative Assessment of Radiation-induced Neuroinflammation - A Proof of Principle Study

Phase 2
Active, not recruiting
Conditions
Brain Tumor
Medulloblastoma
Registration Number
NCT05128903
Lead Sponsor
St. Jude Children's Research Hospital
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Active, not recruiting
Sex
All
Target Recruitment
22
Inclusion Criteria

Inclusion Criteria<br><br> - Participant is at least 8 years of age<br><br> - Participants with histologically confirmed medulloblastoma and are scheduled to<br> receive 36 Gy craniospinal irradiation<br><br> - Participant and/or guardian can understand and is willing to sign a written informed<br> consent document according to institutional guidelines<br><br> - Subjects have either have high-affinity or mixed-affinity TSPO binding sites as<br> determined by the single-nucleotide polymorphism (SNP) rs6971 in the TSPO gene.<br><br>Exclusion Criteria:<br><br> - Participants with a large pseudomeningocele (>4 cm in size) at the surgical site,<br> complications from ventricular access (evidenced by hemorrhage and/or enhancement<br> along the catheter), large subdural effusion in the supra-tentorial compartment (>1<br> cm in the maximum transverse dimension). All of these are expected to induce<br> inflammation.<br><br> - Female participants of childbearing age must not be lactating due to theoretical<br> potential harm to the infant from exposure to radiation.<br><br> - Subjects with low-affinity TSPO binding sites as determined by the single-nucleotide<br> polymorphism (SNP) rs6971 in the TSPO gene.<br><br> - Pregnant subjects.<br><br> - Patients needing sedation for the PET scans.

Exclusion Criteria

Not provided

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
SUVr;SUVr;SUVr;SUVr;SUVr;SUVr;SUVr;SUVr;SUVr;SUVr;SUVr;SUVr;SUVr;SUVr;SUVr;SUVr;SUVr;SUVr
Secondary Outcome Measures
NameTimeMethod
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