Status:
RECRUITING
Investigating the Utility of Demyelination Tracer [18F]3F4AP in Controls and Multiple Sclerosis Subjects
Lead Sponsor:
Massachusetts General Hospital
Conditions:
Multiple Sclerosis
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
Our overall objective is to obtain an initial assessment of the potential value of using \[18F\]3F4AP for imaging demyelinating diseases such as multiple sclerosis: * Aim 1) Assess the safety of \[18...
Eligibility Criteria
Inclusion
- Subjects must be ≥18 and \<65 years of age;
- Able to understand and provide informed consent prior to study procedures
Exclusion
- Subjects with known structural brain disease (e.g. brain tumor or stroke);
- Any contraindication to MRI and/or PET, including:
- Subjects with life vest;
- Subjects with implanted heart device (e.g. ICD, Pacemaker);
- Subjects with metallic fragment or foreign body;
- Subjects with other form of devices or prosthesis that are not MRI compatible, such as insulin pump, joint replacement, hearing aid, cochlear implant, permanent contraceptive devices, etc.;
- Subjects with severe claustrophobia
- Relative or absolute contraindication to Dotarem contrast:
- history of renal disease including acute or chronic severe renal insufficiency (glomerular filtration rate \<60 mL/min/1.73m2);
- history of diabetes mellitus, systemic lupus, multiple myeloma, nephrogenic systemic fibrosis, and other co-morbidities;
- History of hypersensitive reactions to Dotarem and/or gadolinium contrast agent;
- Radiation exposure exceeds current Radiology Department guidelines (i.e., 50 mSv in the prior 12 months);
- Female subjects only: Positive serum pregnancy test, or lactating, or possibility of pregnancy cannot be ruled out prior to dosing;
- Inability to provide written informed consent;
- Any clinically significant acute or unstable physical or psychiatric condition, judged by the investigators based on medical history or screening physical examination, to be incompatible with the study;
- Any physical or psychiatric condition judged by the investigators to be incompatible with the study, based on medical history or screening physical examination;
- Abnormal results on blood tests judged by the investigators to be incompatible with the study.
Key Trial Info
Start Date :
March 25 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 30 2026
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04699747
Start Date
March 25 2021
End Date
November 30 2026
Last Update
February 27 2025
Active Locations (1)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114