Multiple Sclerosis
Conditions
Keywords
Multiple Sclerosis, Entire-body PET imaging
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.
Interventions
DRUGAmyvid radiopharmaceutical
Amyvid (F18-florbetapir) will be evaluated for binding to white matter of the peripheral and central nervous system of participants
DIAGNOSTIC_TESTEntire-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.
Sponsors
Brain Health Alliance
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Masking description
Participants will be de-identified; results will be anonymized.
Intervention model description
Different PET-CT scanners (make and model) determine the different study arms for the intervention defined as a PET-CT medical imaging scan with the Amyvid imaging agent.
Eligibility
Sex/Gender
ALL
Age
25 Years to 55 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Contacts
Primary ContactCarl Taswell, MD, PhD
Outcome results
None listed