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

Trial Summary

What is the purpose of this trial?

The purpose of the study is to collect data to evaluate utility of the using photon-counting CT in a clinical setting.

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 data supports the effectiveness of the treatment Photon-Counting CT for Diagnostic Imaging?

Photon-counting computed tomography (PCCT) is shown to provide higher spatial resolution, improved imaging of iodine, reduced radiation dose, and better artifact reduction compared to traditional CT scans. These benefits can enhance clinical decision-making and patient management in various medical fields, including oncology, cardiovascular, and pediatric radiology. ^{1 2 3 4 5}

Is Photon-Counting CT safe for humans?

Photon-Counting CT (PCCT) is a new technology that has been used in humans and offers potential benefits like reduced radiation exposure, which suggests it may be safer than traditional CT scans. ^{1 2 3 4 5}

How is photon-counting CT different from other imaging treatments?

Photon-counting CT is unique because it uses advanced detectors that convert X-ray photons directly into electrical signals, allowing for higher spatial resolution and better image quality. It also reduces radiation exposure and improves the detection of different energy levels, making it more efficient and accurate than traditional CT scans. ^{1 2 3 4 5}

Research Team

Brian Thomsen

Principal Investigator

GE Healthcare

Eligibility Criteria

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 am 18 years old or older.

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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) 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]

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]

References

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

Photon Counting CT: Technical Principles, Clinical Applications, and Future Prospects. [2023]

2. Germany pubmed.ncbi.nlm.nih.gov

Photon-counting computed tomography - clinical application in oncological, cardiovascular, and pediatric radiology. [2023]

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

Technical Basics and Clinical Benefits of Photon-Counting CT. [2023]

4. Germany pubmed.ncbi.nlm.nih.gov

[CT technology: photon-counting detector computed tomography]. [2023]

5. Germany pubmed.ncbi.nlm.nih.gov

Photon-Counting Computed Tomography - Basic Principles, Potenzial Benefits, and Initial Clinical Experience. [2023]