Entire-body PET Scans for Multiple Sclerosis
EPSMS
Exploratory Study of Entire-body PET Scans for Multiple Sclerosis
1 other identifier
interventional
20
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for early_phase_1 multiple-sclerosis
Started Sep 2024
Shorter than P25 for early_phase_1 multiple-sclerosis
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 12, 2020
CompletedFirst Posted
Study publicly available on registry
May 15, 2020
CompletedStudy Start
First participant enrolled
September 30, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2025
CompletedJanuary 7, 2025
January 1, 2025
1 year
May 12, 2020
January 4, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
Study Arms (2)
Siemens Biograph Vision PET-CT scans
OTHERParallel study arms defined by PET-CT scanners by different manufacturer and model
United Imaging uEXPLORER PET-CT scans
OTHERParallel study arms defined by PET-CT scanners by different manufacturer and model
Interventions
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
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Brain Health Alliance
Ladera Ranch, California, 92694, United States
Related Publications (1)
Taswell C, Villemagne VL, Yates P, Shimada H, Leyton CE, Ballard KJ, Piguet O, Burrell JR, Hodges JR, Rowe CC. 18F-FDG PET Improves Diagnosis in Patients with Focal-Onset Dementias. J Nucl Med. 2015 Oct;56(10):1547-53. doi: 10.2967/jnumed.115.161067. Epub 2015 Aug 6.
PMID: 26251415BACKGROUND
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Carl Taswell, MD, PhD
Brain Health Alliance
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Masking Details
- Participants will be de-identified; results will be anonymized.
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 12, 2020
First Posted
May 15, 2020
Study Start
September 30, 2024
Primary Completion
September 30, 2025
Study Completion
December 30, 2025
Last Updated
January 7, 2025
Record last verified: 2025-01
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
- Time Frame
- Anonymized de-identified data will be available after completion of the study.
- Access Criteria
- Anonymized de-identified data will be available to registered users of the data.
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.