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Entire-body PET Scans for Multiple Sclerosis (EPSMS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04390009
Recruitment Status : Recruiting
First Posted : May 15, 2020
Last Update Posted : September 6, 2022
Sponsor:
Information provided by (Responsible Party):
Brain Health Alliance

Study Description
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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.

Condition or disease Intervention/treatment Phase
Multiple Sclerosis Diagnostic Test: Entire-body PET-CT scans Drug: Amyvid radiopharmaceutical Early Phase 1

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
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.
Masking: None (Open Label)
Masking Description: Participants will be de-identified; results will be anonymized.
Primary Purpose: Diagnostic
Official Title: Exploratory Study of Entire-body PET Scans for Multiple Sclerosis
Actual Study Start Date : September 1, 2022
Estimated Primary Completion Date : March 31, 2023
Estimated Study Completion Date : September 1, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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
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


Outcome Measures
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Primary Outcome Measures :
  1. 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

  2. Psychometric questionnaire for monitoring psychological health [ Time Frame: Up to 90 days ]
    Assessments of participants


Eligibility Criteria
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Ages Eligible for Study:   25 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04390009


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

Locations
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United States, California
Brain Health Alliance Recruiting
Ladera Ranch, California, United States, 92694
Contact: Carl Taswell, MD, PhD    949-481-3121    ctaswell@brainhealthalliance.org   
Sponsors and Collaborators
Brain Health Alliance
Investigators
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Principal Investigator: Carl Taswell, MD, PhD Brain Health Alliance
More Information
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Responsible Party: Brain Health Alliance
ClinicalTrials.gov Identifier: NCT04390009    
Other Study ID Numbers: BHA-2020-11
First Posted: May 15, 2020    Key Record Dates
Last Update Posted: September 6, 2022
Last Verified: September 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code

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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
Keywords provided by Brain Health Alliance:
Multiple Sclerosis
Entire-body PET imaging
Additional relevant MeSH terms:
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Multiple Sclerosis
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
 Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Radiopharmaceuticals
Molecular Mechanisms of Pharmacological Action