Entire-body PET Scans for Multiple Sclerosis

Last updated: January 4, 2025
Sponsor: Brain Health Alliance
Overall Status: Active - Recruiting

Phase

1

Condition

Multiple Sclerosis

Neurologic Disorders

Memory Loss

Treatment

Amyvid radiopharmaceutical

Entire-body PET-CT scans

Clinical Study ID

NCT04390009
BHA-2020-11
  • Ages 25-55
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

To evaluate whether an entire-body positron emission tomography (PET) scanner can be exploited to improve evaluation, monitoring and measurement of both peripheral and central demyelination in multiple sclerosis (MS) patients.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Multiple sclerosis (MS) patients diagnosed by a credentialed neurologist experiencedwith care of multiple sclerosis patients.

  • Normal healthy subjects.

  • Willing and able to lie motionless on the PET-CT scanner bed for at least 10 minutesand up to 20 minutes for the duration of the PET-CT medical imaging scan.

Exclusion

Exclusion Criteria:

  • Any additional complicating medical illness other than MS including any otherneuropsychiatric illness unrelated to MS diagnosed prior to the onset of initialsymptoms of MS.

  • Pregnancy or breast feeding.

  • Diabetes or other metabolic-endocrine disorders.

  • Any known concomitant acute infection.

  • History of metastatic or locally invasive cancer.

  • Recent surgery, chemotherapy or radiation therapy.

Study Design

Total Participants: 20
Treatment Group(s): 2
Primary Treatment: Amyvid radiopharmaceutical
Phase: 1
Study Start date:
September 30, 2024
Estimated Completion Date:
December 30, 2025

Study Description

To collect exploratory data using the most recent PET-CT scanners with their increased detection sensitivity and spatial resolution for the evaluation of F18-florbetapir radiopharmaceutical uptake in the nervous system of the entire body with special attention to correlation of radiotracer activity levels in the myelinated, demyelinated, or remyelinated white matter of multiple sclerosis (MS) patients compared to normal healthy subjects. The pilot study will be conducted on 20 participants as a clinical research trial of PET amyloid and myelin imaging with the primary objective of identifying possible differences in F18-florbetapir radiotracer activity for MS patients compared to normal healthy subjects, and the secondary objective of monitoring psychological health of those participants who elect to be informed of imaging results and who complete a panel of psychometric scales before and after imaging results disclosure.

Connect with a study center

  • Brain Health Alliance

    Ladera Ranch, California 92694
    United States

    Active - Recruiting

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