Entire-body PET Scans for Multiple Sclerosis

Early Phase 1

Recruiting

• Conditions: Multiple Sclerosis
• Interventions: Diagnostic Test: Entire-body PET-CT scans; Drug: Amyvid radiopharmaceutical

• Registration Number: NCT04390009
• Lead Sponsor: Brain Health Alliance

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2020-05-12
• Study First Submitted QC: 2020-05-14
• Study First Posted: 2020-05-15
• Study Start: 2024-09-30
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-04
• Last Update Posted: 2025-01-07
• Primary Completion: 2025-09-30
• Study Completion: 2025-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Siemens Biograph Vision PET-CT scans	Entire-body PET-CT scans	Parallel study arms defined by PET-CT scanners by different manufacturer and model
United Imaging uEXPLORER PET-CT scans	Amyvid radiopharmaceutical	Parallel study arms defined by PET-CT scanners by different manufacturer and model
Siemens Biograph Vision PET-CT scans	Amyvid radiopharmaceutical	Parallel study arms defined by PET-CT scanners by different manufacturer and model
United Imaging uEXPLORER PET-CT scans	Entire-body PET-CT scans	Parallel study arms defined by PET-CT scanners by different manufacturer and model

Primary Outcome Measures

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

Trial Locations

Locations (1)

Brain Health Alliance; 🇺🇸 Ladera Ranch, California, United States