NCT07462507

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
104

participants targeted

Target at P50-P75 for phase_2

Timeline
84mo left

Started Apr 2026

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress4%
Apr 2026Jun 2033

First Submitted

Initial submission to the registry

March 4, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 10, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

April 16, 2026

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2031

Expected
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2033

Last Updated

April 21, 2026

Status Verified

April 1, 2026

Enrollment Period

5.2 years

First QC Date

March 4, 2026

Last Update Submit

April 17, 2026

Conditions

Central Nervous System CancerBrain Metastases

Keywords

Primary brain tumorGliomaGlioblastomaAstrocytomaOligodendrogliomaBrain metastasis

Outcome Measures

Primary Outcomes (1)

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

    \[C-11\]CS1P1-SUV ratio at the baseline and associated 95% confidence interval (CI) will be calculated.

    Baseline

Secondary Outcomes (2)

  • Follow-up changes from the baseline in [C-11]CS1P1 SUV ratio

    Baseline and 24 months

  • Number of participants with adverse events

    From time of scan through 2-3 days

Study Arms (1)

[C-11]-CS1P1 PET

EXPERIMENTAL

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.

Drug: [C-11]-CS1P1Device: Brain MRI

Interventions

[C-11]-CS1P1DRUG

* 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

[C-11]-CS1P1 PET
Brain MRIDEVICE

Optional

[C-11]-CS1P1 PET

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

RECRUITING

Related Links

MeSH Terms

Conditions

Central Nervous System NeoplasmsBrain NeoplasmsGliomaGlioblastomaAstrocytomaOligodendroglioma

Condition Hierarchy (Ancestors)

Nervous System NeoplasmsNeoplasms by SiteNeoplasmsNervous System DiseasesBrain DiseasesCentral Nervous System DiseasesNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasms, Glandular and EpithelialNeoplasms, Nerve Tissue

Study Officials

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

    Washington University School of Medicine

    PRINCIPAL INVESTIGATOR

Central Study Contacts

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

CONTACT

314-362-6110benzingert@wustl.edu

Jayashree Rajamanickam

CONTACT

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

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 4, 2026

First Posted

March 10, 2026

Study Start

April 16, 2026

Primary Completion (Estimated)

June 30, 2031

Study Completion (Estimated)

June 30, 2033

Last Updated

April 21, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)