Investigating the Utility of Demyelination Tracer [18F]3F4AP in Controls and Multiple Sclerosis Subjects
Status:
Recruiting
Trial end date:
2024-11-30
Target enrollment:
Participant gender:
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 [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.