NCT04390009

Entire-body PET Scans for Multiple Sclerosis

Exploratory Study of Entire-body PET Scans for Multiple Sclerosis

• Status: Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Brain Health Alliance · Academic / Other
• Sex: All
• Age: 25 Years – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• Multiple Sclerosis

Interventions

Type	Name	Description
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

Timeline

• Start date: 2024-09-30
• Primary completion: 2025-09-30
• Completion: 2025-12-30
• First posted: 2020-05-15
• Last updated: 2025-01-07

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study
• FDA-regulated device study