Actively Recruiting

Early Phase 1
Age: 25Years - 55Years
All Genders
Healthy Volunteers
ID04390009

Exploratory Study of Entire-body PET-CT Scans Using Amyvid Radiotracer for Multiple Sclerosis Evaluation and Monitoring

Led by Brain Health Alliance · Updated on 2025-01-07

20

Participants Needed

1

Research Sites

65 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are exploring the use of the latest entire-body positron emission tomography (PET) scanners to better evaluate and monitor demyelination in both the peripheral and central nervous system of people with multiple sclerosis (MS). This early phase 1 clinical trial aims to identify differences in the uptake of the radiotracer F18-florbetapir in the white matter of MS patients compared to healthy individuals. The study also looks at psychological health changes in participants who choose to learn their imaging results. Participants will undergo entire-body PET-CT scans using advanced scanners from different manufacturers, including Siemens Biograph Vision and United Imaging uEXPLORER. The study evaluates the binding of Amyvid (F18-florbetapir) to myelinated, demyelinated, or remyelinated white matter throughout the nervous system. The imaging scan requires participants to lie still for 10 to 20 minutes during the procedure. During the study, participants will have a single PET-CT scan lasting one day. Psychological health will be monitored with questionnaires over a period of up to 90 days for those who opt to receive their imaging results. Researchers will measure radiotracer activity in nervous system tissues and track mental well-being changes following disclosure of scan results. This pilot study involves a total of 20 participants and includes evaluations to ensure safe and effective data collection.

CONDITIONS

Official Title

Entire-body PET Scans for Multiple Sclerosis

Who Can Participate

Age: 25Years - 55Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosed with multiple sclerosis by a neurologist experienced in MS care
  • Normal healthy subjects without MS
  • Willing and able to lie motionless on the PET-CT scanner bed for 10 to 20 minutes during imaging
Not Eligible

You will not qualify if you...

  • Having any other medical illness besides MS, including neuropsychiatric illnesses unrelated to MS diagnosed before MS symptoms
  • Pregnancy or breastfeeding
  • Diabetes or other metabolic or endocrine disorders
  • Any known acute infection
  • History of metastatic or locally invasive cancer
  • Recent surgery, chemotherapy, or radiation therapy

AI-Screening

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Trial Site Locations

Total: 1 location

1

Brain Health Alliance

Ladera Ranch, California, United States, 92694

Actively Recruiting

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Research Team

C

Carl Taswell, MD, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

DIAGNOSTIC

Number of Arms

2

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Published Research Related To This Trial