Using a new tracer to image brain damage in multiple sclerosis

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

This study is testing a new imaging tool to see if it can safely and effectively show brain damage in people with multiple sclerosis compared to healthy individuals.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Massachusetts General Hospital (Academic / other)
• Drugs / interventions: Radiation
• Locations: 1 site (Boston, Massachusetts)
• Trial ID: NCT04699747 on ClinicalTrials.gov

What this trial studies

This study aims to evaluate the safety and effectiveness of the radiopharmaceutical [18F]3F4AP for imaging demyelination in patients with multiple sclerosis and healthy volunteers. It will assess the pharmacokinetics of the tracer, comparing its behavior in healthy brain tissue versus demyelinated lesions. Additionally, the study will investigate the reproducibility of the imaging results and correlate them with MRI findings. The overall goal is to determine the potential of [18F]3F4AP as a valuable tool for diagnosing and monitoring multiple sclerosis.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 to 65 who are either healthy volunteers or diagnosed with multiple sclerosis.

Not a fit: Patients with known structural brain diseases or contraindications to MRI and PET imaging will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved imaging techniques for diagnosing and monitoring multiple sclerosis.

How similar studies have performed: While this approach is novel, similar imaging techniques have shown promise in other studies focused on demyelinating diseases.

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.

Where this trial is running

Boston, Massachusetts

• Massachusetts General Hospital — Boston, Massachusetts, United States (Recruiting)

Study contacts

• Study coordinator: Pedro Brugarolas, PhD

Conditions Multiple Sclerosis; Demyelination; Brain imaging; Positron Emission Tomography; Radiopharmaceutical