Central Nervous System CancerPhase 2NCT07462507
Inflammation in Primary and Secondary Malignancies of the Central Nervous System Using [C-11]-CS1P1
A Phase 2 study testing [C-11]-CS1P1 and Brain MRI in people with Central Nervous System Cancer and Brain Metastases, run by Washington University School of Medicine at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Central Nervous System Cancer, Brain Metastases
- What is being tested?
- [C-11]-CS1P1 and Brain MRI
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Apr 2026to 30 Jun 2033
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Washington University School of Medicine
St Louis, Missouri, 63110
Tammie L.S. Benzinger, M.D., Ph.D., 314-362-1558, benzingert@wustl.edu
Jayashree Rajamanickam, 314-273-6140, jayashree.r@wustl.edu
About this study
Official title: Investigation of Inflammation in Primary and Secondary Malignancies of the Central Nervous System Using [C-11]-CS1P1
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.
Read the detailed description
This is a prospective, single-arm interventional imaging study designed to evaluate the investigational PET radiotracer [C-11]-CS1P1 in adults with primary or secondary central nervous system malignancies. [C-11]-CS1P1 PET may provide complementary information about disease activity, treatment response, and the tumor microenvironment in central nervous system cancers.
Eligible participants will be adults with confirmed primary central nervous system tumors (for example, gliomas) or secondary central nervous system involvement (brain metastases or other CNS metastases). After providing informed consent, participants will undergo a baseline [C-11]-CS1P1 PET scan in addition to their routine clinical imaging. The PET scan will be performed on a PET/CT or PET/MR scanner following intravenous administration of [C-11]-CS1P1, using a standardized acquisition protocol for brain imaging. Participants will be monitored for adverse events related to tracer administration and radiation exposure, which are expected to remain within accepted research limits.
Participants will be invited to return for one follow-up [C 11]-CS1P1 PET scan within 24 months of the baseline scan, preferably within approximately 6 months after treatment. Follow up imaging will allow assessment of longitudinal changes in [C 11]-CS1P1 uptake in relation to treatment and disease course. Clinical management will not be altered by participation in this study.
Quantitative PET parameters (for example, standardized uptake values, tumor to background ratios, and volumetric measures) will be derived from tumor and normal appearing brain. Qualitative assessments of tracer uptake patterns will also be performed. These PET measures will be compared with MRI characteristics, treatment history, and available clinical outcomes (including radiographic progression and survival) to explore the potential of [C 11]-CS1P1 PET as a diagnostic biomarker of tumor activity and treatment response in central nervous system malignancies. This exploratory study is intended to generate preliminary data that may inform the design of future trials using [C 11]-CS1P1 PET in this patient population.
- Conditions
- Central Nervous System Cancer, Brain Metastases
- Being tested
- [C-11]-CS1P1, Brain MRI
- Keywords
- Primary brain tumor, Glioma, Glioblastoma, Astrocytoma, Oligodendroglioma, Brain metastasis
- Medical subject headings
- Central Nervous System Neoplasms, Brain Neoplasms, Glioma, Glioblastoma, Astrocytoma, Oligodendroglioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
[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
Brain MRIDevice
Optional
| Study group | Role | What they receive |
|---|---|---|
| [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. Receives: Drug: [C-11]-CS1P1; Device: Brain MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
[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.
Measured: Baseline
Secondary outcomes (2)
Follow-up changes from the baseline in [C-11]CS1P1 SUV ratio
[C-11]CS1P1-SUV ratio at the follow up scan and change from the baseline as well as their associated 95% confidence interval (CI) will be calculated.
Measured: Baseline and 24 months
Number of participants with adverse events
Measured and graded per CTCAE v 6.0.
Measured: From time of scan through 2-3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2026
- Study start16 Apr 2026
- Primary completion30 Jun 2031 (estimated)
- Study completion30 Jun 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Central Nervous System CancerStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 104 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tammie L.S. Benzinger, M.D., Ph.D., Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07462507
- Sponsor's protocol ID
- 202603116
- Status last verified
- Apr 2026
- First submitted
- 4 Mar 2026
- Last updated
- 21 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No