Entire-body PET Scans for Multiple Sclerosis

Multiple Sclerosis Clinical Trial

— EPSMS  

Official title:

Exploratory Study of Entire-body PET Scans for Multiple Sclerosis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04390009
• Other study ID #: BHA-2020-11
• Status: Recruiting
• Phase: Early Phase 1
• Start date: April 30, 2023
• Est. completion date: October 30, 2024

Study information

• Verified date: July 2023
• Source: Brain Health Alliance
• Contact: Carl Taswell, MD, PhD
• Phone: 949-481-3121
• Email: ctaswell[@]brainhealthalliance.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: October 30, 2024
• Est. primary completion date: April 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 25 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Diagnostic Test:
• Entire-body PET-CT scans
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.

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

Locations

Country	Name	City	State
United States	Brain Health Alliance	Ladera Ranch	California

Sponsors (1)

Lead Sponsor	Collaborator
Brain Health Alliance

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Entire-body PET imaging of demyelination of peripheral and central nervous system	Exploratory analysis of relative regional increases and/or decreases of Amyvid activity	During 1 day single PET-CT scan
Primary	Psychometric questionnaire for monitoring psychological health	Assessments of participants	Up to 90 days

External Links

•   Amended Protocol for Exploratory Study of Entire-body PET Scans for Multiple Sclerosis (EPSMS)
•   Research Protocol for Exploratory Study of Entire-body PET Scans for Multiple Sclerosis (EPSMS)