Entire-body PET Scans for Multiple Sclerosis (EPSMS)

July 11, 2023 updated by: Brain Health Alliance

Exploratory Study of Entire-body PET Scans for Multiple Sclerosis

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Entire-body PET imaging of demyelination of peripheral and central nervous system
Time Frame: During 1 day single PET-CT scan
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
Time Frame: Up to 90 days
Assessments of participants
Up to 90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Brain Health Alliance

Investigators

  • Principal Investigator: Carl Taswell, MD, PhD, Brain Health Alliance

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 30, 2023

Primary Completion (Estimated)

April 30, 2024

Study Completion (Estimated)

October 30, 2024

Study Registration Dates

First Submitted

May 12, 2020

First Submitted That Met QC Criteria

May 14, 2020

First Posted (Actual)

May 15, 2020

Study Record Updates

Last Update Posted (Actual)

July 13, 2023

Last Update Submitted That Met QC Criteria

July 11, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BHA-2020-11

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD 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 Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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