Recruiting
Phase 2

C-11-CS1P1 PET

Sponsor:

Washington University School of Medicine

Code:

NCT07462507

Conditions

Central Nervous System Cancer

Brain Metastases

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

[C-11]-CS1P1

Brain MRI

Study Details

Brief summary:

Adult patients with primary or secondary central nervous system malignancies will be invited to undergo a baseline \[C-11\]-CS1P1 PET scan and a follow-up scan within 24 months of the baseline scan (preferably within 6-months post-treatment).The study will describe patterns of tracer uptake in tumors and normal brain and explore how these patterns relate to MRI findings, treatments received, and clinical outcomes.

Conditions

Central Nervous System Cancer

Brain Metastases

Study ID

NCT07462507

Start date

Apr 16, 2026

Status verified date

Apr, 2026

Completion date

Jun 30, 2033

Anticipated

Primary completion date

Jun 30, 2031

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

104 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: [C-11]-CS1P1 PET

C-11\]-CS1P1 PET image acquisition up to 90 minutes will be acquired at baseline and at follow-up visit within 24 months (preferably within 6 months post treatment), along with an optional brain MRI.

Interventions

[C-11]-CS1P1

  • The investigational radiotracer \[C-11\]-CS1P1 is an S1P1 PET imaging agent.
  • The PET imaging will be acquired either in a PET/MR scanner or the PET/CT scanner

Brain MRI

Optional

Primary outcome measure

  • [C-11]CS1P1 Standardized uptake value (SUV) ratio of tumor to non-tumor regions of interest (ROIs) [ Time Frame: Baseline ]

Central Contacts and Locations

Central contacts

Tammie L.S. Benzinger, M.D., Ph.D.

314-362-6110benzingert@wustl.edu

Jayashree Rajamanickam

314-273-6140jayashree.r@wustl.edu

Locations

Washington University School of Medicine

Recruiting

St Louis, Missouri, United States, 63110

Contacts

Tammie L.S. Benzinger, M.D., Ph.D.

314-362-1558benzingert@wustl.edu

Jayashree Rajamanickam

314-273-6140jayashree.r@wustl.edu

Principal Investigator:

Tammie L.S. Benzinger, M.D., Ph.D.

More Information

Sponsor

Washington University School of Medicine

Last update posted

Apr 21, 2026

Last verified

Apr, 2026

Keywords

  • Primary brain tumor
  • Glioma
  • Glioblastoma
  • Astrocytoma
  • Oligodendroglioma
  • Brain metastasis

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Washington University School of Medicine on 2026-04-21.