NCT04699747 Investigating the Utility of Demyelination Tracer [18F]3F4AP in Controls and Multiple Sclerosis Subjects
| NCT ID | NCT04699747 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Massachusetts General Hospital |
| Condition | Multiple Sclerosis |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2021-03-25 |
| Primary Completion | 2026-11-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 60 participants in total. It began in 2021-03-25 with a primary completion date of 2026-11-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 \[18F\]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.
Eligibility Criteria
Inclusion Criteria: * Subjects must be ≥18 and \<65 years of age; * Able to understand and provide informed consent prior to study procedures Exclusion Criteria: * 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT04699747 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Multiple Sclerosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04699747 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT04699747 currently recruiting?
Yes, NCT04699747 is actively recruiting participants. Contact the research team at pbrugarolas@mgh.harvard.edu for enrollment information.
Where is the NCT04699747 trial being conducted?
This trial is being conducted at Boston, United States.
Who is sponsoring the NCT04699747 clinical trial?
NCT04699747 is sponsored by Massachusetts General Hospital. The trial plans to enroll 60 participants.
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