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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	Yes
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years - 65 Years
Gender	All

More Inclusion & Exclusion 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.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT04699747
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 1
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Massachusetts General Hospital
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Multiple Sclerosis

Arms & Interventions

Arms

Experimental: Multiple sclerosis

F-18 3F4AP PET Scan

Active Comparator: Healthy controls

F-18 3F4AP PET Scan

Interventions

Drug: - F-18 3F4AP

Subjects will be injected once per imaging session (a maximum of 2 imaging sessions) with up to 10 mCi (±20%) of 18-F 3F4AP as a rapid intravenous bolus (within 1 min).

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Massachusetts General Hospital, Boston, Massachusetts

Status

Recruiting

Address

Massachusetts General Hospital

Boston, Massachusetts, 02114

Site Contact

Pedro Brugarolas, PhD

[email protected]

617-643-4574

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