Whole-Body PET Scans for Multiple Sclerosis

(EPSMS Trial)

Overseen By Carl Taswell, MD, PhD

Age: 18 - 65

Sex: Any

Trial Phase: Phase < 1

Sponsor: Brain Health Alliance

Disqualifiers: Neuropsychiatric illness, Diabetes, Cancer, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how whole-body PET scans, a type of imaging test, can track and understand changes in people with multiple sclerosis (MS), a disease affecting the brain and spinal cord. The study aims to determine if these scans can better measure the damage caused by MS. Participants will be divided into groups to test different PET-CT scanners. Suitable candidates are those diagnosed with MS by a neurologist and who can remain still for up to 20 minutes during a scan. As an Early Phase 1 trial, this research focuses on understanding how these imaging techniques work in people, offering participants a chance to contribute to groundbreaking advancements in MS diagnostics.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that whole-body PET-CT scans are safe for evaluating multiple sclerosis?

Research has shown that whole-body PET-CT scans, such as the United Imaging uEXPLORER and Siemens Biograph Vision, are generally easy for patients to handle. These scans use advanced technology to look inside the body, combining PET (positron emission tomography) and CT (computed tomography) to create detailed images.

The United Imaging uEXPLORER PET-CT, approved by the FDA for diagnostic use, is known for its high-quality scans that cover the entire body in one session. This capability allows it to quickly and efficiently provide extensive information, useful for tracking conditions like multiple sclerosis. FDA approval indicates a certain level of safety, as it has been used in medical settings.

Similarly, the Siemens Biograph Vision PET-CT system produces clear images and is used in various medical practices. It is also FDA-approved, meeting safety standards for use in people.

Past studies have used these types of scans without serious side effects, suggesting that patients generally tolerate them well. However, since this is an early-stage trial, more remains to be learned about how these technologies might affect patients over time. Researchers will closely monitor participants during the study to ensure their safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about whole-body PET-CT scans for multiple sclerosis because these scans offer a comprehensive view of the entire body, potentially identifying inflammation and lesions with greater accuracy than traditional MRI scans. Unlike the standard MRI approach, which primarily focuses on the brain and spinal cord, whole-body PET-CT can detect subtle changes throughout the body that might be contributing to the disease. By using different PET-CT scanners, like the United Imaging uEXPLORER and Siemens Biograph Vision, the trial aims to determine which technology provides the most detailed and useful images. This could lead to earlier diagnosis and more personalized treatment plans for multiple sclerosis patients.

What evidence suggests that these PET-CT scans are effective for evaluating multiple sclerosis?

This trial will compare the effectiveness of different PET-CT scanners in tracking changes in multiple sclerosis (MS). Studies have shown that whole-body PET-CT scans can detect and track changes in MS more effectively. Participants will be assigned to one of two study arms. The United Imaging uEXPLORER scanner, used in one arm, captures images of the entire body at once, providing detailed information about MS's impact on the body. Research indicates that this scanner provides accurate and reliable images, potentially improving how doctors monitor MS progression. In the other arm, the Siemens Biograph Vision PET-CT is known for its clear images and ability to measure myelin density, crucial for understanding MS. These features suggest that both scanners could be useful tools for tracking changes in MS. ^{1 3 6 7 8}

Who Is on the Research Team?

Carl Taswell, MD, PhD

Principal Investigator

Brain Health Alliance

Are You a Good Fit for This Trial?

This trial is for individuals with Multiple Sclerosis diagnosed by a specialized neurologist, as well as healthy subjects. Participants must be able to stay still on the PET-CT scanner bed for 10-20 minutes. Those who've had recent surgery, cancer treatments, are pregnant or breastfeeding, have diabetes or other metabolic disorders, acute infections, or any serious illness besides MS cannot join.

Inclusion Criteria

I can stay still on a scanner bed for up to 20 minutes.

People who do not have any known health problems.

I have been diagnosed with MS by a specialist.

Exclusion Criteria

I have diabetes or another metabolic disorder.

I have recently undergone surgery, chemotherapy, or radiation therapy.

I have no other major illnesses besides MS.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Imaging

Participants undergo entire-body PET-CT scans to evaluate F18-florbetapir radiopharmaceutical uptake

1 day

1 visit (in-person)

Psychological Assessment

Participants complete a panel of psychometric scales before and after imaging results disclosure

Up to 90 days

Follow-up

Participants are monitored for safety and effectiveness after imaging

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Amyvid radiopharmaceutical
• Entire-body PET-CT scans

Trial Overview The study is testing if whole-body PET scans using Amyvid radiopharmaceutical can better assess and monitor demyelination in MS patients. It aims to improve how we evaluate the spread and impact of MS throughout the body.

How Is the Trial Designed?

Group I: United Imaging uEXPLORER PET-CT scans Experimental Treatment 2 Interventions

Parallel study arms defined by PET-CT scanners by different manufacturer and model

Group II: Siemens Biograph Vision PET-CT scans Experimental Treatment 2 Interventions

Parallel study arms defined by PET-CT scanners by different manufacturer and model

Who Is Running the Clinical Trial?

Brain Health Alliance

Lead Sponsor

Trials

1

Recruited

20+

Published Research Related to This Trial

In a case of acute multiple sclerosis, a CT scan revealed a large plaque, indicating significant brain tissue involvement.

Repeated CT scans and 123I-HIPDM studies demonstrated that single photon emission CT can effectively monitor the recovery and changes in brain tissue associated with the demyelination process.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sequential computed tomography and 123I-HIPDM scans in multiple sclerosis with large plaque. A case report. Pozzilli, C., Pantano, P., Bozzao, L., et al.[2018]

MRI is a highly sensitive tool for evaluating disease activity in multiple sclerosis, being at least five times more effective than traditional clinical assessments.

In a recent clinical trial, MRI demonstrated about twice the sensitivity compared to clinical measurements in detecting the treatment effects of a drug, highlighting its importance in clinical research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Magnetic resonance imaging in the evaluation of clinical trials in multiple sclerosis. Paty, DW., Li, DK., Oger, JJ., et al.[2019]

Total-body PET scanners significantly enhance lesion detection and diagnostic quality by improving sensitivity and spatial resolution, allowing for faster acquisition times and reduced radiation exposure for patients, which is particularly beneficial for pediatric cases.

While total-body PET technology offers many advantages, such as improved image quality and the ability to perform simultaneous dynamic imaging, it also presents challenges like increased false positives and logistical issues that require careful interpretation by radiologists.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Total-body PET/CT - First Clinical Experiences and Future Perspectives. Ng, QK., Triumbari, EKA., Omidvari, N., et al.[2023]

The article discusses imaging outcome measures for trials focused on progressive multiple sclerosis, highlighting the importance of accurate imaging techniques in assessing treatment efficacy.

A correction was issued regarding the spelling of 'positron emission tomography,' which was mistakenly written as 'position emission tomography,' emphasizing the need for precision in scientific communication.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Erratum. [2020]

In a long-term follow-up study of 108 patients with monosymptomatic optic neuritis, 44% of those with normal initial MRIs developed new brain lesions after 10 to 14 years, indicating that MRI changes can occur without clinical symptoms of multiple sclerosis.

For patients with abnormal baseline MRIs, 74% showed additional lesions over the follow-up period, suggesting that while some patients may not develop clinical signs, MRI abnormalities can still accumulate, which is important for patient counseling regarding the long-term implications of optic neuritis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term brain magnetic resonance imaging changes after optic neuritis in patients without clinically definite multiple sclerosis. [2022]

Three advanced total-body PET/CT systems (PennPET Explorer, uExplorer, and Biograph Vision Quadra) have been developed, featuring axial fields of view (FOVs) between 1 and 2 meters, significantly enhancing imaging capabilities.

The increased sensitivity of these systems allows for shorter imaging times, lower radiation doses, and the potential for new dynamic imaging techniques across various medical applications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hybrid total-body pet scanners-current status and future perspectives. Nadig, V., Herrmann, K., Mottaghy, FM., et al.[2023]

Positron emission tomography (PET) imaging offers a non-invasive way to study multiple sclerosis (MS) in living patients, providing specific and quantitative insights into the disease's pathology that MRI cannot.

The development of PET imaging biomarkers for neuroinflammation in MS could significantly improve prognosis and treatment response measurement, potentially leading to better management of this complex and often undertreated condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Imaging of microglial activation in MS using PET: Research use and potential future clinical application. Airas, L., Rissanen, E., Rinne, J.[2018]

The EXPLORER PET/CT scanner is the first of its kind to cover the entire human body in a single scan, allowing for total-body pharmacokinetic studies with frame durations as short as 1 second, which could revolutionize imaging techniques.

Initial human imaging studies demonstrate that this scanner significantly improves image quality and sensitivity, enabling diagnostic PET images to be obtained with very low amounts of radioactive tracer and in much shorter acquisition times.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

First Human Imaging Studies with the EXPLORER Total-Body PET Scanner. Badawi, RD., Shi, H., Hu, P., et al.[2020]

In a study involving 46 patients, PET/MR hybrid scanners demonstrated comparable effectiveness to PET/CT in detecting lesions, identifying 99.2% of lesions found by PET/CT, with 88.4% of patients showing the same number of detected foci.

While PET/MR showed slightly lower quantitation of tracer uptake (21% lower for SUV(max) and 11% lower for SUV(avg)), these differences were statistically significant, indicating a need for further research to understand the quantitative accuracy of PET/MR.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of lesion detection and quantitation of tracer uptake between PET from a simultaneously acquiring whole-body PET/MR hybrid scanner and PET from PET/CT. Wiesmüller, M., Quick, HH., Navalpakkam, B., et al.[2021]

Total body (TB) PET systems have significantly improved the ability to simultaneously image the distribution of radiopharmaceuticals in major organs, enhancing both clinical and research applications.

Current TB-PET systems, with an axial field-of-view ranging from 1 to 2 meters, are expected to expand the field of molecular imaging and improve clinical practices within just a few years of their introduction.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Total-body PET: a new paradigm for molecular imaging. Daube-Witherspoon, ME., Pantel, AR., Pryma, DA., et al.[2023]

Citations

1. siemens-healthineers.com siemens-healthineers.com/en-us/molecular-imaging/pet-ct/biograph-vision

Biograph Vision PET/CT Biograph Vision provides high image resolution and sensitivity for precise quantification that can positively impact health outcomes. Ultra Dynamic Range (UDR) ...

2. link.springer.com link.springer.com/article/10.1007/s00259-022-05770-4

Quantitative assessment of myelin density using [ 11 C] ... [ 11 C]MeDAS PET can be used for quantification of myelin density in MS patients and is able to distinguish differences in myelin density within MS lesions.

3. brainhealthalliance.org brainhealthalliance.org/pub/docs/BHA202011EPSMS-RP0514.pdf

Report BHA-2020-11: Research Protocol for Exploratory ... Significance: Improved molecular imaging with new entire-body PET scanners that provide improved detection sensitivity and spatial resolution ...

4. jnm.snmjournals.org jnm.snmjournals.org/content/early/2024/12/05/jnumed.123.266896

Myelin Imaging of the Spinal Cord in Animal Models and ... MS patients had significantly lower [11C]MeDAS uptake in the upper spinal cord (C5–T3) than did controls. The [11C]MeDAS PET signal was ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7937710/

Assessment of Image Quality and Lesion Detectability With ... The aim of our study was to assess the overall image quality and lesion detection capability improvement in patients undergoing digital PET/CT ...

6. siemens-healthineers.com siemens-healthineers.com/en-us/molecular-imaging/pet-ct/biograph-mct

Biograph mCT PET/CT scanner Biograph mCT PET/CT nuclear medicine scanner. A truly hybrid system that supports your ability to serve more patients and generate more revenue.

7. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf23/K231833.pdf

July 13, 2023 Siemens Medical Solutions USA, Inc. Alaine ... The Siemens Biograph systems are combined X-Ray Computed Tomography (CT) and. Positron Emission Tomography (PET) scanners that provide ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S0001299824001077

Role of Total Body PET/CT in Inflammatory Disorders This review aims to further explore the role and benefits of LAFOV scanners for imaging various inflammatory conditions while addressing future developments.