← Back to Search

Virus Therapy

[18F]DPA714 PET Imaging for Brain Inflammation

Phase 2

Waitlist Available

Led By Asim Bag, MD

Research Sponsored by St. Jude Children's Research Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Participant is at least 8 years of age

Participants with histologically confirmed medulloblastoma and are scheduled to receive 36 Gy craniospinal irradiation

Must not have

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.

Subjects with low-affinity TSPO binding sites as determined by the single-nucleotide polymorphism (SNP) rs6971 in the TSPO gene.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up follow up 3: up to 2 years after radiation therapy

Awards & highlights

No Placebo-Only Group

Summary

This trial is studying a brain inflammation marker called TSPO using a PET scan. They will also be doing MRI's to study microstructure damages caused by neuroinflammation in different parts of the brain.

Who is the study for?

This trial is for individuals at least 8 years old with confirmed medulloblastoma, scheduled for craniospinal irradiation. They must understand and sign consent forms, have specific TSPO gene binding sites (not low-affinity), and not require sedation for PET scans. Pregnant or lactating women and those with certain complications from previous surgeries are excluded.

What is being tested?

[18F]DPA714 PET tracer is being tested to measure brain inflammation after whole brain radiation therapy in patients with brain tumors. The study will scan participants' brains multiple times over two years to assess changes in inflammation related to radiation doses received.

What are the potential side effects?

Potential side effects may include discomfort from the injection of the radioactive tracer used during PET scans, reactions related to lying still during imaging procedures, and exposure to radiation beyond normal levels due to the imaging techniques.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am at least 8 years old.

Select...

I have medulloblastoma and will get 36 Gy of radiation to my brain and spine.

Select...

My genetic test shows I have a specific variant in the TSPO gene.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have complications like a large fluid-filled swelling, bleeding, or fluid buildup in my brain.

Select...

My genetic test shows I have low-affinity TSPO binding sites.

Select...

I need sedation for PET scans.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ follow up 3: up to 2 years after radiation therapy

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~follow up 3: up to 2 years after radiation therapy

This trial's timeline: 3 weeks for screening, Varies for treatment, and follow up 3: up to 2 years after radiation therapy for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

SUVr

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: ParticipantsExperimental Treatment1 Intervention

Participants who meet the eligibility criteria in the study will receive Translocation Protein (TSPO) Positron Emission Tomography (PET) for longitudinal, quantitative assessment of brain neuroinflammation following whole brain radiation therapy.

0 / 6Eligibility criteria met