Actively Recruiting
Investigating the Utility of Demyelination Tracer [18F]3F4AP in Controls and Multiple Sclerosis Subjects
Led by Massachusetts General Hospital · Updated on 2025-02-27
60
Participants Needed
1
Research Sites
296 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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 \[18F\]3F4AP in healthy volunteers and subjects with multiple sclerosis (MS). Hypothesis 1: Administration of \[18F\]3F4AP will result in no changes in vitals or other adverse events. * Aim 2) Assess the pharmacokinetics of a bolus infusion of \[18F\]3F4AP in humans including healthy volunteers and MS patients. Hypothesis 2: the pharmacokinetics of \[18F\]3F4AP at the whole brain level will be similar in controls and MS subjects. The kinetics in demyelinated lesions will be slower than in healthy control areas. * Aim 3) Assess the reproducibility of \[18F\]3F4AP in humans. Hypothesis 3: the test/retest variability of \[18F\]3F4AP within the same subject will be lower than 10%. * Aim 4) Correlate MR brain images with \[18F\]3F4AP PET brain images. Hypothesis 4A: all the lesions seen on the MRI will show increased signal (VT or SUV) on the PET images. Hypothesis 4B: some of the lesions on the MRI will show increased signal (VT or SUV) on the PET but not all. * Aim 5) Correlate \[18F\]3F4AP PET signal with neuropsychological testing in people with MS. Hypothesis 5: increased PET signal (VT or SUV) will correlate with impaired Single Digit Modality Test (SDMT) scores. * Aim 6) Correlate \[18F\]3F4AP PET signal with EDSS score in people with MS. Hypothesis 6: increased PET signal (VT or SUV) will correlate with higher EDSS scores.
CONDITIONS
Official Title
Investigating the Utility of Demyelination Tracer [18F]3F4AP in Controls and Multiple Sclerosis Subjects
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Subjects must be 18 years or older and younger than 65 years of age
- Able to understand and provide informed consent prior to study procedures
You will not qualify if you...
- Known structural brain disease such as brain tumor or stroke
- Contraindications to MRI and/or PET, including life vest, implanted heart devices (e.g., ICD, Pacemaker), metallic fragments or foreign bodies, or other non-MRI compatible devices such as insulin pumps, joint replacements, hearing aids, cochlear implants, or permanent contraceptive devices
- 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, or other co-morbidities
- History of hypersensitive reactions to Dotarem and/or gadolinium contrast agents
- Radiation exposure exceeding 50 mSv in the prior 12 months
- Female subjects who are pregnant, lactating, or possibly pregnant without confirmation
- Inability to provide written informed consent
- Any clinically significant acute or unstable physical or psychiatric condition incompatible with the study as judged by investigators
- Any physical or psychiatric condition incompatible with the study based on medical history or screening physical examination
- Abnormal blood test results judged incompatible with the study by investigators
AI-Screening
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Trial Site Locations
Total: 1 location
1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
Research Team
P
Pedro Brugarolas, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
BASIC_SCIENCE
Number of Arms
2
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