Entire-body PET Scans for Multiple Sclerosis

Purpose

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.

Condition

  • Multiple Sclerosis

Eligibility

Eligible Ages
Between 25 Years and 55 Years
Eligible Sex
All
Accepts 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.

Study Design

Phase
Early Phase 1
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Parallel Assignment
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.
Primary Purpose
Diagnostic
Masking
None (Open Label)
Masking Description
Participants will be de-identified; results will be anonymized.

Arm Groups

ArmDescriptionAssigned Intervention
Other
Siemens Biograph Vision PET-CT scans 		Parallel study arms defined by PET-CT scanners by different manufacturer and model
  • Diagnostic Test: Entire-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.
  • Drug: Amyvid radiopharmaceutical
    Amyvid (F18-florbetapir) will be evaluated for binding to white matter of the peripheral and central nervous system of participants
Other
United Imaging uEXPLORER PET-CT scans 		Parallel study arms defined by PET-CT scanners by different manufacturer and model
  • Diagnostic Test: Entire-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.
  • Drug: Amyvid radiopharmaceutical
    Amyvid (F18-florbetapir) will be evaluated for binding to white matter of the peripheral and central nervous system of participants

Recruiting Locations

Brain Health Alliance
Ladera Ranch, California 92694
Contact:
Carl Taswell, MD, PhD
949-481-3121
ctaswell@brainhealthalliance.org

More Details

Status
Recruiting
Sponsor
Brain Health Alliance

Study Contact

Carl Taswell, MD, PhD
949-481-3121
ctaswell@brainhealthalliance.org

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.