Multiple SclerosisEarly Phase 1EPSMSNCT04390009
Entire-body PET Scans for Multiple Sclerosis
A Early Phase 1 study testing Entire-body PET-CT scans and Amyvid radiopharmaceutical in people with Multiple Sclerosis, run by Brain Health Alliance at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 25 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Entire-body PET-CT scans and Amyvid radiopharmaceutical
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Sep 2024to 30 Jun 2028
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Brain Health Alliance
Ladera Ranch, California, 92694
Carl Taswell, MD, PhD, 949-481-3121, ctaswell@brainhealthalliance.org
About this study
Official title: 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.
Read the 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.
- Conditions
- Multiple Sclerosis
- Being tested
- Entire-body PET-CT scans, Amyvid radiopharmaceutical
- Keywords
- Multiple Sclerosis, Entire-body PET imaging
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Entire-body PET-CT scansDiagnostic test
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 radiopharmaceuticalDrug
Amyvid (F18-florbetapir) will be evaluated for binding to white matter of the peripheral and central nervous system of participants
| Study group | Role | What they receive |
|---|---|---|
| Siemens Biograph Vision PET-CT scans | Other | Parallel study arms defined by PET-CT scanners by different manufacturer and model Receives: Diagnostic Test: Entire-body PET-CT scans; Drug: Amyvid radiopharmaceutical |
| United Imaging uEXPLORER PET-CT scans | Other | Parallel study arms defined by PET-CT scanners by different manufacturer and model Receives: Diagnostic Test: Entire-body PET-CT scans; Drug: Amyvid radiopharmaceutical |
What is being measured
The primary outcome is the main question the study is designed to answer.
Entire-body PET imaging of demyelination of peripheral and central nervous system
Exploratory analysis of relative regional increases and/or decreases of Amyvid activity
Measured: During 1 day single PET-CT scan
Psychometric questionnaire for monitoring psychological health
Assessments of participants
Measured: Up to 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2020
- Study start30 Sep 2024
- Primary completion30 Dec 2027 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brain Health Alliance
- Sponsor type
- University, hospital or other
- Collaborators
- Center for Molecular Imaging & Therapy, Shreveport LA, Northern California PET Imaging Center, Sacramento CA
- Responsible party
- Sponsor
- Investigators
- Carl Taswell, MD, PhD, Principal investigator, Brain Health Alliance
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04390009
- Sponsor's protocol ID
- BHA-2020-11
- Acronym
- EPSMS
- Status last verified
- Oct 2026
- First submitted
- 12 May 2020
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 26251415
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploratory Study of Entire-body PET Scans for Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT04390009
- Acronym / sponsor ID
- EPSMS / BHA-2020-11
- Conditions
- Multiple Sclerosis
- Keywords
- Multiple Sclerosis, Entire-body PET imaging
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Brain Health AllianceUniversity, hospital or other
- Collaborators
- Center for Molecular Imaging & Therapy, Shreveport LA, Northern California PET Imaging Center, Sacramento CA
- Study start
- 30 Sep 2024 (actual)
- Primary completion
- 30 Dec 2027 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 15 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Siemens Biograph Vision PET-CT scans | Other | Diagnostic Test: Entire-body PET-CT scans, Drug: Amyvid radiopharmaceuticalParallel study arms defined by PET-CT scanners by different manufacturer and model |
| United Imaging uEXPLORER PET-CT scans | Other | Diagnostic Test: Entire-body PET-CT scans, Drug: Amyvid radiopharmaceuticalParallel study arms defined by PET-CT scanners by different manufacturer and model |
Who may qualify
- Ages
- 25 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Entire-body PET-CT scansEntire-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. | Diagnostic test | Siemens Biograph Vision PET-CT scans, United Imaging uEXPLORER PET-CT scans |
| Amyvid radiopharmaceuticalAmyvid (F18-florbetapir) will be evaluated for binding to white matter of the peripheral and central nervous system of participants | Drug | Siemens Biograph Vision PET-CT scans, United Imaging uEXPLORER PET-CT scans |
Primary outcome
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
Psychometric questionnaire for monitoring psychological health
Time frame: Up to 90 days
Assessments of participants
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2026.
- Background: PubMed 26251415Taswell 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.
- Research Protocol for Exploratory Study of Entire-body PET Scans for Multiple Sclerosis (EPSMS)Link provided by the sponsor.
- Amended Protocol for Exploratory Study of Entire-body PET Scans for Multiple Sclerosis (EPSMS)Link provided by the sponsor.
- EPSMS Clinical TrialLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Carl Taswell, MD, PhD principal investigator
Brain Health Alliance
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Entire-body PET-CT scans and Amyvid radiopharmaceutical in people with Multiple Sclerosis, run by Brain Health Alliance at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Carl Taswell, MD, PhD (949-481-3121, ctaswell@brainhealthalliance.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Entire-body PET imaging of demyelination of peripheral and central nervous system (time frame: During 1 day single PET-CT scan). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04390009, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2026.