[C-11]-CS1P1 for Brain Cancer

Overseen By Jayashree Rajamanickam

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Washington University School of Medicine

Disqualifiers: Prior cranial radiotherapy, Pregnancy, Advanced renal or liver failure, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 2

104 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new imaging treatment called [C-11]-CS1P1 for individuals with brain cancer. Researchers aim to determine how this imaging agent appears in brain tumors compared to normal brain tissue. They will use this information to understand the relationship between imaging results, MRI findings, and treatments received. Individuals with brain cancer who have not undergone radiation and can remain still for scans might be suitable candidates. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group, offering participants an opportunity to contribute to significant advancements in brain cancer imaging.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

What prior data suggests that [C-11]-CS1P1 is safe for brain cancer patients?

Research has shown that [C-11]-CS1P1 is safe for humans. Studies have found it can examine inflammation in diseases like multiple sclerosis without causing harm. In early tests, patients tolerated the treatment well, and no serious side effects occurred. Evidence from human studies supports its safety for imaging, making it a promising option for those considering participation in this trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for brain cancer, which typically include surgery, radiation, and chemotherapy, [C-11]-CS1P1 represents an innovative approach by using a PET imaging technique. This treatment involves the use of a radioactive tracer, [C-11]-CS1P1, to provide detailed images of the brain, helping to track the cancer more precisely. Researchers are excited about this because it offers a non-invasive way to monitor how well the cancer responds to treatment over time, potentially leading to more personalized and effective care.

What evidence suggests that [C-11]-CS1P1 PET is effective for brain cancer?

Studies have shown that [C-11]-CS1P1 PET scans, which participants in this trial will undergo, can provide important information about brain tumors. This imaging technique reveals disease activity and treatment effectiveness. Research indicates that C-11 choline PET effectively detects brain tumors, especially post-surgery. Additionally, the special substance used in [C-11]-CS1P1 PET scans may offer valuable insights into the tumor environment and brain inflammation. Overall, [C-11]-CS1P1 PET imaging is a promising tool for assessing brain cancer. ^{3 6 7 8 9}

Who Is on the Research Team?

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

Principal Investigator

Washington University School of Medicine

Are You a Good Fit for This Trial?

This trial is for adults (18 or older) with a brain or central nervous system tumor that has not yet been treated with radiation. Participants must be able to give consent themselves or have someone legally authorized to do so.

Inclusion Criteria

I am 18 years old or older.

I can give written consent or have someone legally allowed to consent for me.

I have a brain or spinal tumor that has not been treated with radiation.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Imaging

Participants undergo a baseline [C-11]-CS1P1 PET scan to evaluate disease activity and treatment response

1 day

1 visit (in-person)

Follow-up Imaging

Participants return for a follow-up [C-11]-CS1P1 PET scan to assess longitudinal changes in tracer uptake

Within 24 months of baseline, preferably within 6 months post-treatment

1 visit (in-person)

Follow-up

Participants are monitored for adverse events related to tracer administration and radiation exposure

2-3 days post-scan

What Are the Treatments Tested in This Trial?

Interventions

• [C-11]-CS1P1

Trial Overview

The study uses a special PET scan called [C-11]-CS1P1 and standard brain MRI to look at inflammation in brain tumors before and after treatment, tracking changes over time.

How Is the Trial Designed?

Group I: [C-11]-CS1P1 PET Experimental Treatment 2 Interventions

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.

Who Is Running the Clinical Trial?

Washington University School of Medicine

Lead Sponsor

Trials

2,027

Recruited

2,353,000+

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11429583/

Value of 11C-Methionine PET Imaging in High-Grade Gliomas

11C-MET PET offers valuable insights for tumor classification, facilitates treatment planning, and aids in monitoring therapeutic response.

2.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07462507

Study Details | NCT07462507 | Inflammation in Primary ...

[C-11]-CS1P1 PET may provide complementary information about disease activity, treatment response, and the tumor microenvironment in central nervous system ...

3.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/9015080/

Brain Tumors: Detection With C-11 Choline PET

Conclusion: C-11 choline PET can depict brain tumors effectively. This method was clinically useful in patients who had undergone surgery. Publication types.

4.

profiles.wustl.edu

profiles.wustl.edu/en/publications/evaluation-of-sup11supccs1p1-in-healthy-young-and-older-adults/

Evaluation of [>11>C]CS1P1 in Healthy Young and Older ...

Graphical Logan analysis reliably estimated volume of distribution (Vt), and Vt closely reproduced S1PR1 distribution in the brain. CONCLUSIONS: ...

5.

jnm.snmjournals.org

jnm.snmjournals.org/content/62/supplement_1/1591

Preliminary Human Dosimetry Studies of [11C]-CS1P1, a ...

The total effective dose (ED) per MBq of injected activity of [11C]-CS1P1 in human is 1.60 ± 0.15 µSv/MBq. Based on the preliminary results, the ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC9635683/

Phase 1 Evaluation of 11C-CS1P1 to Assess Safety ... - PMC

IMPLICATIONS FOR PATIENT CARE: 11C-CS1P1 is safe for human use and can be used to study inflammation in diseases such as multiple sclerosis.

7.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/35332093/

Phase 1 Evaluation of 11C-CS1P1 to Assess Safety ... - PubMed

These results support the safety of 11 C-CS1P1 for evaluation of inflammation in human clinical populations.

8.

profiles.wustl.edu

profiles.wustl.edu/en/publications/phase-1-evaluation-of-sup11supc-cs1p1-to-assess-safety-and-dosime/

Phase 1 Evaluation of >11>C-CS1P1 to Assess Safety and ...

Conclusion: These results support the safety of 11C-CS1P1 for evaluation of inflammation in human clinical populations. Dosimetry permits ...

9.

radiographics.rsna.org

radiographics.rsna.org/doi/10.1148/radiology.202.2.9015080

Brain tumors: detection with C-11 choline PET. | Radiology

CONCLUSION: C-11 choline PET can depict brain tumors effectively. This method was clinically useful in patients who had undergone surgery.