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Whole-Body PET Scans for Multiple Sclerosis (EPSMS Trial)

Phase < 1
Recruiting
Led By Carl Taswell, MD, PhD
Research Sponsored by Brain Health Alliance
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
Be between 18 and 65 years old
Must not have
History of metastatic or locally invasive cancer
Any known concomitant acute infection
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 90 days
Awards & highlights
No Placebo-Only Group

Summary

This trial will test whether a PET scanner can help improve the evaluation, monitoring and measurement of both peripheral and central demyelination in MS patients.

Who is the study for?
This trial is for individuals with Multiple Sclerosis diagnosed by a specialized neurologist, as well as healthy subjects. Participants must be able to stay still on the PET-CT scanner bed for 10-20 minutes. Those who've had recent surgery, cancer treatments, are pregnant or breastfeeding, have diabetes or other metabolic disorders, acute infections, or any serious illness besides MS cannot join.
What is being tested?
The study is testing if whole-body PET scans using Amyvid radiopharmaceutical can better assess and monitor demyelination in MS patients. It aims to improve how we evaluate the spread and impact of MS throughout the body.
What are the potential side effects?
Amyvid may cause side effects like headache, nausea, injection site pain or reactions. Since it's a radioactive drug used for imaging purposes, there's also a small risk associated with exposure to radiation during the PET scan.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can stay still on a scanner bed for up to 20 minutes.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My cancer has spread or grown into nearby tissues.
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I currently have an acute infection.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 90 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 90 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Entire-body PET imaging of demyelination of peripheral and central nervous system
Psychometric questionnaire for monitoring psychological health

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: United Imaging uEXPLORER PET-CT scansExperimental Treatment2 Interventions
Parallel study arms defined by PET-CT scanners by different manufacturer and model
Group II: Siemens Biograph Vision PET-CT scansExperimental Treatment2 Interventions
Parallel study arms defined by PET-CT scanners by different manufacturer and model

Find a Location

Who is running the clinical trial?

Brain Health AllianceLead Sponsor
Carl Taswell, MD, PhDPrincipal InvestigatorBrain Health Alliance

Media Library

Entire-body PET-CT scans Clinical Trial Eligibility Overview. Trial Name: NCT04390009 — Phase < 1
Multiple Sclerosis Research Study Groups: United Imaging uEXPLORER PET-CT scans, Siemens Biograph Vision PET-CT scans
Multiple Sclerosis Clinical Trial 2023: Entire-body PET-CT scans Highlights & Side Effects. Trial Name: NCT04390009 — Phase < 1
Entire-body PET-CT scans 2023 Treatment Timeline for Medical Study. Trial Name: NCT04390009 — Phase < 1
~8 spots leftby Nov 2025
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