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

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the treatment Amyvid radiopharmaceutical and entire-body PET-CT scans for multiple sclerosis?

PET scans, like those used in the study, can provide specific and detailed information about the disease process in multiple sclerosis, which helps in understanding and potentially improving treatment options. ^{1 2 3 4 5}

How does the whole-body PET-CT scan treatment for multiple sclerosis differ from other treatments?

Whole-body PET-CT scans are unique because they provide a comprehensive view of the entire body in a single scan, allowing for dynamic imaging and better detection of changes in the body. This approach is different from traditional treatments for multiple sclerosis, which typically focus on managing symptoms rather than providing detailed imaging of the entire body. ^{6 7 8 9 10}

Research Team

Carl Taswell, MD, PhD

Principal Investigator

Brain Health Alliance

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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 (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]

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]

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]

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]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Sequential computed tomography and 123I-HIPDM scans in multiple sclerosis with large plaque. A case report. [2018]

2. England pubmed.ncbi.nlm.nih.gov

Erratum. [2020]

3. United States pubmed.ncbi.nlm.nih.gov

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

4. England pubmed.ncbi.nlm.nih.gov

Imaging of microglial activation in MS using PET: Research use and potential future clinical application. [2018]

5. United States pubmed.ncbi.nlm.nih.gov

Magnetic resonance imaging in the evaluation of clinical trials in multiple sclerosis. [2019]

6. England pubmed.ncbi.nlm.nih.gov

Total-body PET: a new paradigm for molecular imaging. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

First Human Imaging Studies with the EXPLORER Total-Body PET Scanner. [2020]

8. Germany 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. [2021]

9. Germany pubmed.ncbi.nlm.nih.gov

Hybrid total-body pet scanners-current status and future perspectives. [2023]

10. United States pubmed.ncbi.nlm.nih.gov

Total-body PET/CT - First Clinical Experiences and Future Perspectives. [2023]