Actively Recruiting

Phase 1
Age: 18Years - 65Years
All Genders
Healthy Volunteers
NCT04699747

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

Led by Massachusetts General Hospital · Updated on 2025-02-27

60

Participants Needed

1

Research Sites

296 weeks

Total Duration

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AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 65Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Subjects must be 18 years or older and younger than 65 years of age
  • Able to understand and provide informed consent prior to study procedures
Not Eligible

You will not qualify if you...

  • Known structural brain disease such as brain tumor or stroke
  • Contraindications to MRI and/or PET, including life vest, implanted heart devices (e.g., ICD, Pacemaker), metallic fragments or foreign bodies, or other non-MRI compatible devices such as insulin pumps, joint replacements, hearing aids, cochlear implants, or permanent contraceptive devices
  • 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, or other co-morbidities
  • History of hypersensitive reactions to Dotarem and/or gadolinium contrast agents
  • Radiation exposure exceeding 50 mSv in the prior 12 months
  • Female subjects who are pregnant, lactating, or possibly pregnant without confirmation
  • Inability to provide written informed consent
  • Any clinically significant acute or unstable physical or psychiatric condition incompatible with the study as judged by investigators
  • Any physical or psychiatric condition incompatible with the study based on medical history or screening physical examination
  • Abnormal blood test results judged incompatible with the study by investigators

AI-Screening

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Trial Site Locations

Total: 1 location

1

Massachusetts General Hospital

Boston, Massachusetts, United States, 02114

Actively Recruiting

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Research Team

P

Pedro Brugarolas, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

SINGLE_GROUP

Primary Purpose

BASIC_SCIENCE

Number of Arms

2

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