Status:
ACTIVE_NOT_RECRUITING
Investigation of Inflammation Using [C-11]-CS1P1
Lead Sponsor:
Tammie L. S. Benzinger, MD, PhD
Conditions:
Alzheimer Disease
Eligibility:
All Genders
18+ years
Brief Summary
There is a compelling need for a noninvasive imaging approach to measure S1P1 in both preclinical models of diseases and humans. PET measures of S1P1 expression is critical for elucidating the pathoph...
Detailed Description
The primary objective of the initial IND study is to determine the safety of the \[11C\]-CS1P1 for PET imaging of S1P1 expression. The investigators will first complete whole-body PET dosimetry studie...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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.
Key Trial Info
Start Date :
November 2 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
July 8 2026
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04517552
Start Date
November 2 2020
End Date
July 8 2026
Last Update
August 7 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Washington University School of Medicine
St Louis, Missouri, United States, 63110