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RecruitingPhase 1

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 65 Years
Sex
All sexes
Healthy volunteers
Accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: MRI scans

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Hypothesis 4A: all the lesions seen on the MRI will show increased signal (VT or SUV) on the PET images."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests [18F]3F4AP, a tracer used in PET brain scans, in healthy adults and adults with multiple sclerosis (MS). It checks the tracer’s safety, how it moves through the brain, and whether repeat scans give similar results. It also compares scans with MRI images and MS test scores to see how well the tracer shows damage to the protective covering of nerves.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be age 18 to 64.
  • Be able to understand the study and give informed consent before study procedures.

Who can't join

  • Have a known disease that changes the brain’s structure, such as a brain tumor or stroke.
  • Cannot safely have MRI or PET scans because of a wearable heart device, an implanted heart device, metal in the body, or another device not safe for MRI; or have a severe fear of small spaces.
  • Have a reason not to receive Dotarem scan dye, such as kidney disease, diabetes, lupus, multiple myeloma (a blood cancer), nephrogenic systemic fibrosis (a tissue-scarring disease), or other medical conditions.
  • Have had an allergic reaction to Dotarem or another gadolinium scan dye.
  • Have radiation exposure above the radiology department’s limit of 50 mSv in the past 12 months.
  • Have a positive pregnancy blood test, are breastfeeding, or cannot rule out pregnancy before receiving the tracer.
  • Cannot give written informed consent.
  • Have a physical or mental health condition, or abnormal blood test results, that the study doctors believe make the study unsuitable for you.

Simplified for readability. The official criteria below are what the study team uses.

Official 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.

Study sites (1)

MA