Entire-body PET Scans for Multiple Sclerosis

Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age25-55
SponsorBrain Health Alliance

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Entire-body PET-CT scans

    Diagnostic test

    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.

  • Amyvid radiopharmaceutical

    Drug

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

Treatment groups

20 Participants
are divided into 2 treatment groups
Group A: Siemens Biograph Vision PET-CT scansOther 2 interventions
Group B: United Imaging uEXPLORER PET-CT scansOther 2 interventions

Trial outcomes

Primary outcomes

1

Entire-body PET imaging of demyelination of peripheral and central nervous system

Exploratory analysis of relative regional increases and/or decreases of Amyvid activity

Time frame
During 1 day single PET-CT scan
2

Psychometric questionnaire for monitoring psychological health

Assessments of participants

Time frame
Up to 90 days

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Brain Health Alliance

Lead sponsor

Center for Molecular Imaging & Therapy, Shreveport LA

Collaborator

Northern California PET Imaging Center, Sacramento CA

Collaborator