Imaging inflammation in primary and metastatic brain tumors with [C-11]-CS1P1 PET

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, single-arm imaging study using the investigational PET radiotracer [C-11]-CS1P1 in adults with primary brain tumors or brain metastases. Participants receive a baseline [C-11]-CS1P1 PET scan (on PET/CT or PET/MR) and are invited for one follow-up scan within 24 months, preferably around 6 months after treatment. The study will quantify tracer uptake in tumors and normal brain and compare those patterns with MRI findings, treatments received, and clinical outcomes. Safety monitoring for tracer administration and radiation exposure will be conducted, and clinical care will not be changed by participation.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Male or female, any race
* Age ≥ 18 years
* Capable of providing written informed consent OR having a legally authorized representative (LAR) to provide informed consent for volunteering to undergo research procedure
* Has a clinical, radiographic, or pathological diagnosis of primary or secondary CNS malignancy that has not been treated with radiotherapy

Exclusion Criteria:

* Hypersensitivity to \[C-11\]-CS1P1 or any of its excipients
* Contraindications to PET, CT or MRI (e.g. certain incompatible electronic medical devices, inability to lie still for extended periods) that make it potentially unsafe for the individual to participate
* Prior cranial radiotherapy
* Severe claustrophobia that would require general anesthesia
* Women who are currently pregnant or breastfeeding
* Any condition that, in the opinion of the Sponsor-Investigator or designee could increase risk to the participant, limit the participant's ability to tolerate the research procedures or interfere with the collection of the data (e.g., advanced renal or liver failure)
* Current or recent (within 12 months prior to screening) participation in research studies involving radioactive agents such that the total research-related radiation dose to the participant in any given year would exceed the limits set forth in the U.S. Code of Federal Regulations (CFR) Title 21 Section 361.1. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?FR=361.1.

Where it's running

• Washington University School of Medicine
  St Louis, Missouri, United States Recruiting

Study contacts

• Principal investigator: Tammie L.S. Benzinger, M.D., Ph.D. — Washington University School of Medicine
• Study coordinator: Tammie L.S. Benzinger, M.D., Ph.D.
• Email: benzingert@wustl.edu
• Phone: 314-362-6110

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.