NCT04517552 · ACTIVE NOT RECRUITING
Investigation of Inflammation Using [C-11]-CS1P1
This trial is testing a new PET imaging tool called [11C]-CS1P1, which is designed to measure neuroinflammation in the brain. Researchers want to see if this radioactive tracer can reliably detect a protein called S1P1, which is involved in immune activity in the brain. The phase is unspecified, meaning this is likely early feasibility or imaging validation work — not a treatment trial, and not yet anywhere near proven clinical use.
You may qualify if
- Male or female, any race;
- Age ≥ 18 years;
- Capable of providing written informed consent for volunteering to undergo research procedures.
- Healthy volunteer or volunteer with a diagnosis of MS
You're excluded if
- Hypersensitivity to [11C]-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;
- Severe claustrophobia
- Women who are currently pregnant or breast-feeding;
- Currently undergoing radiation therapy;
- 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 collection of the data (e.g., renal or liver failure, advanced cancer);
- Participants who in the last 6 months experienced any of the following cardiovascular conditions or findings in the screening electrocardiogram (ECG): unstable cardiac arrhythmias, myocardial infarction, unstable angina, stroke, transient ischemic attack or decompensated heart failure requiring hospitalization or Class III/IV heart failure;
- Must not have participated in any clinical trial involving a study drug or device within the 30-days prior to study enrollment;
- Must not participate in another drug or device study prior to the end of this study participation;
- 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.
The sponsor's own eligibility wording, lightly reformatted. The study team makes the final eligibility decision — worth discussing with your doctor.
Eligibility criteria as of 2025-08-07