Imaging inflammation in primary and metastatic brain tumors with [C-11]-CS1P1 PET
Investigation of Inflammation in Primary and Secondary Malignancies of the Central Nervous System Using [C-11]-CS1P1
This trial will test a new PET tracer, [C-11]-CS1P1, in adults with primary or secondary brain tumors to see if tracer patterns of inflammation relate to MRI, treatments, and clinical outcomes.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 104 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Washington University School of Medicine Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (St Louis, Missouri) |
| Trial ID | NCT07462507 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Adults aged 18 or older with a confirmed primary central nervous system tumor or brain metastasis who have not had cranial radiotherapy and can undergo PET/CT or PET/MR are ideal candidates.
Not a fit: Patients who have already received cranial radiotherapy, are pregnant or breastfeeding, have contraindications to PET/CT or MRI, or have severe claustrophobia that prevents scanning are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, the tracer could help doctors visualize inflammation in and around brain tumors and provide extra information to interpret MRI and follow treatment response.
How similar studies have performed: Other inflammation-targeted PET tracers have shown promise in prior studies, but [C-11]-CS1P1 is a novel radiotracer with limited prior human data.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
St Louis, Missouri
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.