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NCT Number: NCT04390009

Entire-body PET Scans for Multiple Sclerosis

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.

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Key information

Age range

25 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Brain Health Alliance

Ladera Ranch, California, 92694, United States

Location status: Recruiting

Location contact

Carl Taswell, MD, PhD

CONTACT

[email protected]

949-481-3121

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Multiple sclerosis (MS) patients diagnosed by a credentialed neurologist experienced with care of multiple sclerosis patients.
  • Normal healthy subjects.
  • Willing and able to lie motionless on the PET-CT scanner bed for at least 10 minutes and up to 20 minutes for the duration of the PET-CT medical imaging scan.

Exclusion criteria

  • Any additional complicating medical illness other than MS including any other neuropsychiatric illness unrelated to MS diagnosed prior to the onset of initial symptoms 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.

Treatment and study plan

Entire-body PET-CT scans

Diagnostic Test

Entire-body PET-CT scans will be performed with state-of-the-art scanners with different manufacturers' models including Siemens Biograph Vision, United Imaging uEXPLORER and possibly other recently FDA-approved PET-CT scanners.

Amyvid radiopharmaceutical

Drug

Amyvid (F18-florbetapir) will be evaluated for binding to white matter of the peripheral and central nervous system of participants

Primary outcomes

  1. Entire-body PET imaging of demyelination of peripheral and central nervous system

    Time frame: During 1 day single PET-CT scan

    Exploratory analysis of relative regional increases and/or decreases of Amyvid activity

  2. Psychometric questionnaire for monitoring psychological health

    Time frame: Up to 90 days

    Assessments of participants

Study contacts

Contact information is provided by the study sponsor or research team.

Carl Taswell, MD, PhD

CONTACT

[email protected]

949-481-3121

Sponsors and collaborators

Lead sponsor

Brain Health Alliance

Other

Registry information

Official study title

Exploratory Study of Entire-body PET Scans for Multiple Sclerosis

Acronym: EPSMS

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
May 15, 2020
Registry last updated
Jan 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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