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Entire-body PET Scans for Multiple Sclerosis (EPSMS)

Primary Purpose

Multiple Sclerosis

Status
Recruiting
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Entire-body PET-CT scans
Amyvid radiopharmaceutical
Sponsored by
Brain Health Alliance
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Multiple Sclerosis focused on measuring Multiple Sclerosis, Entire-body PET imaging

Eligibility Criteria

25 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Brain Health AllianceRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Siemens Biograph Vision PET-CT scans

United Imaging uEXPLORER PET-CT scans

Arm Description

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

Outcomes

Primary Outcome Measures

Entire-body PET imaging of demyelination of peripheral and central nervous system
Exploratory analysis of relative regional increases and/or decreases of Amyvid activity
Psychometric questionnaire for monitoring psychological health
Assessments of participants

Secondary Outcome Measures

Full Information

First Posted
May 12, 2020
Last Updated
July 11, 2023
Sponsor
Brain Health Alliance
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1. Study Identification

Unique Protocol Identification Number
NCT04390009
Brief Title
Entire-body PET Scans for Multiple Sclerosis
Acronym
EPSMS
Official Title
Exploratory Study of Entire-body PET Scans for Multiple Sclerosis
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 30, 2023 (Actual)
Primary Completion Date
April 30, 2024 (Anticipated)
Study Completion Date
October 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Brain Health Alliance

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
Keywords
Multiple Sclerosis, Entire-body PET imaging

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
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)
Masking Description
Participants will be de-identified; results will be anonymized.
Allocation
Non-Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Siemens Biograph Vision PET-CT scans
Arm Type
Other
Arm Description
Parallel study arms defined by PET-CT scanners by different manufacturer and model
Arm Title
United Imaging uEXPLORER PET-CT scans
Arm Type
Other
Arm Description
Parallel study arms defined by PET-CT scanners by different manufacturer and model
Intervention Type
Diagnostic Test
Intervention Name(s)
Entire-body PET-CT scans
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Amyvid radiopharmaceutical
Intervention Description
Amyvid (F18-florbetapir) will be evaluated for binding to white matter of the peripheral and central nervous system of participants
Primary Outcome Measure Information:
Title
Entire-body PET imaging of demyelination of peripheral and central nervous system
Description
Exploratory analysis of relative regional increases and/or decreases of Amyvid activity
Time Frame
During 1 day single PET-CT scan
Title
Psychometric questionnaire for monitoring psychological health
Description
Assessments of participants
Time Frame
Up to 90 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Carl Taswell, MD, PhD
Phone
949-481-3121
Email
ctaswell@brainhealthalliance.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carl Taswell, MD, PhD
Organizational Affiliation
Brain Health Alliance
Official's Role
Principal Investigator
Facility Information:
Facility Name
Brain Health Alliance
City
Ladera Ranch
State/Province
California
ZIP/Postal Code
92694
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carl Taswell, MD, PhD
Phone
949-481-3121
Email
ctaswell@brainhealthalliance.org

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
All information and data will be shared with investigators at collaborating imaging sites prior to publication of the results, and with all other investigators after publication of the results.
IPD Sharing Time Frame
Anonymized de-identified data will be available after completion of the study.
IPD Sharing Access Criteria
Anonymized de-identified data will be available to registered users of the data.
IPD Sharing URL
https://epsms.brainhealthalliance.net
Links:
URL
https://www.brainiacsjournal.org/arc/pub/Taswell2020EPSMS
Description
Research Protocol for Exploratory Study of Entire-body PET Scans for Multiple Sclerosis (EPSMS)
URL
https://www.brainiacsjournal.org/arc/pub/Taswell2023EPSMS
Description
Amended Protocol for Exploratory Study of Entire-body PET Scans for Multiple Sclerosis (EPSMS)

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Entire-body PET Scans for Multiple Sclerosis

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