Photon-Counting CT for Diagnostic Imaging

Overseen By Melissa Challman

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: GE Healthcare

Disqualifiers: Pregnancy, Renal insufficiency, Allergy, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

100 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method for CT scans using photon-counting technology (CT Photon-Counting). The goal is to determine if this method provides clearer images for doctors to diagnose conditions. Participants should have recently had or be scheduled for a CT scan of the head, neck, heart, chest, abdomen, pelvis, or limbs. Those over 18 who meet these criteria might be suitable candidates. As an unphased trial, this study offers a unique opportunity to contribute to advancements in medical imaging technology.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this device is safe for diagnostic imaging?

Previous studies have shown that photon-counting CT (PCCT) improves image quality while reducing radiation exposure, potentially making it safer than traditional CT scans. Research indicates that PCCT counts X-ray photons directly, preserving all information and enhancing accuracy.

No major safety problems have been reported with PCCT, which is encouraging for those considering joining a trial using this technology. However, it is important to remember that new technologies are still under study, and more data is needed to fully understand their safety in every situation. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Photon-Counting CT for diagnostic imaging because it promises to enhance image resolution and reduce radiation dose compared to traditional CT scans. Unlike conventional CT technology, which uses energy-integrating detectors, photon-counting CT employs detectors that count individual photons. This allows for better differentiation of tissues and potentially earlier detection of diseases. Additionally, by improving image clarity while using less radiation, it could offer a safer and more precise option for patients who require frequent imaging.

What evidence suggests that photon-counting CT is effective for diagnostic imaging?

Research has shown that photon-counting CT scans, which participants in this trial will receive, improve medical imaging by providing clearer pictures with less radiation. Studies indicate that this technology offers better image details, helping doctors see tiny structures more clearly. It also reduces electronic noise, making the images less blurry. Importantly, photon-counting CT distinguishes between different types of tissues better than regular CT scans. These features suggest that photon-counting CT could be a more effective tool for accurately diagnosing medical conditions. ^{1 3 5 6 7}

Who Is on the Research Team?

Brian Thomsen

Principal Investigator

GE Healthcare

Are You a Good Fit for This Trial?

This trial is for adults over 18 who can consent to participate and are scheduled or have had a CT scan of the head, neck, heart, chest, abdomen, pelvis, or extremities within the past 120 days or next 30 days.

Inclusion Criteria

I can sign and understand the consent form.

I have had or will have a CT scan of major body parts in the last 120 days or next 30 days.

Exclusion Criteria

Individuals who are pregnant or lactating

Individuals who were previously enrolled in this study

For contrast-enhanced CT exams, individuals with known or suspected allergy to iodinated contrast agents

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Data Collection

Participants are scanned using the investigational Pluto Photon-Counting CT system to collect data for evaluation

1 year

Follow-up

Participants are monitored for safety and effectiveness after data collection

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• CT Photon-Counting

Trial Overview The study is testing photon-counting CT technology in clinical settings. It aims to gather data on its utility by comparing it with standard CT scans that participants have already undergone or will undergo.

How Is the Trial Designed?

Group I: Subject's Scanned with Investigational Device Experimental Treatment 1 Intervention

Eligible and consented subjects will be scanned using the investigational Pluto Photon-Counting CT system.

Who Is Running the Clinical Trial?

GE Healthcare

Lead Sponsor

Trials

307

Recruited

634,000+

Fotis Vlachos

GE Healthcare

Chief Marketing Officer since 2024

PhD in Molecular Biology and Biochemistry from the University of Massachusetts, MBA from the Wharton School of the University of Pennsylvania

Peter J. Arduini

GE Healthcare

Chief Executive Officer since 2022

MBA from Northwestern University, BSc in Marketing from Susquehanna University

Stanford University

Collaborator

Trials

2,527

Recruited

17,430,000+

Published Research Related to This Trial

Photon-counting computed tomography (PCCT) uses advanced detectors to convert X-ray photons into electrical signals, leading to higher spatial resolution and improved imaging quality.

PCCT offers significant benefits such as reduced radiation doses, fewer artifacts, and the ability to perform multienergy imaging, making it a promising advancement in clinical imaging techniques.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Photon Counting CT: Technical Principles, Clinical Applications, and Future Prospects. Wu, Y., Ye, Z., Chen, J., et al.[2023]

Novel photon-counting detector CT (PCD-CT) offers improved spatial resolution and enhanced accuracy in detecting small, low-contrast structures compared to traditional CT systems.

The review highlights the potential clinical benefits of PCD-CT, particularly following its recent commercial introduction, suggesting it could significantly enhance diagnostic capabilities in medical imaging.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Technical Basics and Clinical Benefits of Photon-Counting CT. Flohr, T., Schmidt, B.[2023]

Photon-counting detector computed tomography (PCD-CT) allows for counting individual photons, leading to improved spatial resolution and reduced image noise compared to traditional CT, which enhances image quality.

PCD-CT offers significant clinical benefits, including reduced radiation doses and fewer beam hardening artifacts, particularly benefiting vulnerable patient groups such as those in oncology, cardiology, and pediatrics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Photon-counting computed tomography - clinical application in oncological, cardiovascular, and pediatric radiology. Hagen, F., Soschynski, M., Weis, M., et al.[2023]

Photon-counting computed tomography (PCCT) offers significant improvements over traditional CT by counting individual photons, leading to enhanced spatial resolution and reduced image noise, which can improve diagnostic accuracy.

PCCT has the potential to reduce radiation doses and minimize beam hardening artifacts, making it a safer and more effective imaging option in clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Photon-Counting Computed Tomography - Basic Principles, Potenzial Benefits, and Initial Clinical Experience. Stein, T., Rau, A., Russe, MF., et al.[2023]

Photon-counting detector computed tomography (PCD-CT) significantly reduces image noise and radiation dose while improving spatial resolution and iodine signal, making it a superior option compared to conventional CT technology.

This advanced imaging technique allows for spectral evaluation and the creation of virtual images, enhancing diagnostic capabilities and potentially enabling single-scan multiphase imaging, although further research is needed for broader clinical applications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[CT technology: photon-counting detector computed tomography]. Layer, YC., Kravchenko, D., Dell, T., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9955798/

Photon-Counting Computed Tomography (PCCT) Photon-counting computed tomography (PCCT) is a new advanced imaging technique that is going to transform the standard clinical use of computed tomography (CT) ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S2211568424001955

Photon-counting CT: Technical Review of Clinical Possibilities Photon-counting detectors offer better dose efficiency, eliminate electronic noise, improve spatial resolution and have intrinsic spectral sensitivity.

3. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK602525/

Photon-Counting CT: High Resolution, Less Radiation - NCBI PCCT is intended to provide a higher resolution image with a lower radiation dose and improve tissue differentiation at a greater speed with less electronic ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S0720048X2500275X

Photon-counting CT: An updated review of clinical results Photon-counting computed tomography (PCD-CT) is an advancing imaging technology that offers improved spatial resolution, energy-resolved imaging, and spectral ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT03878134

Translational Development of Photon-counting CT Imaging Study Overview · lower radiation dose · greater spatial resolution · reduced imaging noise · x-ray energy discrimination.

6. columbiaradiology.org columbiaradiology.org/news/what-photon-counting-ct-and-how-it-could-change-way-youre-diagnosed

What Is Photon-Counting CT — and How It Could Change ... With photon-counting CT, X-ray photons are converted directly into digital electrical signals and then counted without information loss—adding a ...

7. siemens-healthineers.com siemens-healthineers.com/en-us/computed-tomography/ct-technologies-and-innovations/photon-counting-ct

Understand the technology behind photon-counting CT A photon-counting detector being able to count the charges created by individual x‐ray photons as well as measuring their energy level.