Entire-body PET Scans for Multiple Sclerosis

Study Overview
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Brief Summary
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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
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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.

Official Title
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Exploratory Study of Entire-body PET Scans for Multiple Sclerosis

Conditions
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Multiple Sclerosis

Intervention / Treatment
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* Diagnostic Test: Entire-body PET-CT scans
* Drug: Amyvid radiopharmaceutical


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Siemens Biograph Vision PET-CT scans<br>Parallel study arms defined by PET-CT scanners by different manufacturer and model | Diagnostic Test: Entire-body PET-CT scans<br>* 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.<br>Drug: Amyvid radiopharmaceutical<br>* Amyvid (F18-florbetapir) will be evaluated for binding to white matter of the peripheral and central nervous system of participants<br>|
| Other: United Imaging uEXPLORER PET-CT scans<br>Parallel study arms defined by PET-CT scanners by different manufacturer and model | Diagnostic Test: Entire-body PET-CT scans<br>* 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.<br>Drug: Amyvid radiopharmaceutical<br>* Amyvid (F18-florbetapir) will be evaluated for binding to white matter of the peripheral and central nervous system of participants<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Entire-body PET imaging of demyelination of peripheral and central nervous system | Exploratory analysis of relative regional increases and/or decreases of Amyvid activity | During 1 day single PET-CT scan | 
| Psychometric questionnaire for monitoring psychological health | Assessments of participants | Up to 90 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Multiple Sclerosis, Entire-body PET imaging