Title
Entire-body PET Scans for Multiple Sclerosis
Exploratory Study of Entire-body PET Scans for Multiple Sclerosis
Phase
Early Phase 1Lead Sponsor
Brain Health AllianceStudy Type
InterventionalStatus
RecruitingIndication/Condition
Multiple SclerosisIntervention/Treatment
Amyvid radiopharmaceutical ...Study Participants
20To 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.
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.
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 (F18-florbetapir) will be evaluated for binding to white matter of the peripheral and central nervous system of participants
Parallel study arms defined by PET-CT scanners by different manufacturer and model
Parallel study arms defined by PET-CT scanners by different manufacturer and model
Inclusion Criteria: Multiple sclerosis (MS) patients with advanced state of the disease as evidenced by severe disability scores (EDSS > 5) with impaired motor control of extremities. 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.
