Imaging study using a new tracer to detect nerve damage in multiple sclerosis

Trial details

Who runs it

Massachusetts General Hospital

Trial code

NCT04699747

Record updated

7 October 2026

Original description

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:Read full original descriptionShow less

Investigating the Utility of Demyelination Tracer [18F]3F4AP in Controls and Multiple Sclerosis Subjects

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.

Inclusion: Subjects must be ≥18 and <65 years of age; Able to understand and provide informed consent prior to study procedures.

Exclusion: Radiation exposure exceeds current Radiology Department guidelines (i.e., 50 mSv in the prior 12 months); 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; 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; 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; Abnormal results on blood tests judged by the investigators to be incompatible with the study.

ClinicalTrials.gov NCT04699747