Computed TomographyNCT06769594

Next Generation CT System

An observational study of Computed Tomography, run by GE Healthcare at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The purpose of the study is to collect data to evaluate utility of a next generation CT system in a clinical setting. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Computed Tomography
What is being tested?: Investigational CT Scan
Type of treatment: Medical device
How many people: 64 participants
Where: 1 siteUnited States
Study dates: 8 Apr 2025to 6 Mar 2026
Phase: Observational
Are there results?: None posted in the registry

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 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: The subject population will consist of adults that are 18-years of age or older, and who have undergone a prior clinically indicated imaging exam of at least one of the following anatomical areas: head, neck, heart, chest, abdomen, pelvis, and/or extremities.

Who may be able to join

Subjects may be included in this study if they meet the following criteria:
Who are 18 year of age or older;
Able to sign and date the informed consent form; AND
Who have in the past 120 days or will in the future 30 days from the day of consent undergo a clinically indicated imaging exam (MRI, CT, radiograph, nuclear medicine, ultrasound, bone material density, interventional radiology procedure) of the head, neck, heart, chest, abdomen, pelvis, or extremities where images are available for this prior exam.

Who cannot join

Subjects may be excluded from participating in study if they meet any of the following criteria:
Who are pregnant or lactating;
Who were previously enrolled in this study;
For contrast-enhanced CT exams, anyone with known or suspected allergy to iodinated contrast agents;
For contrast-enhanced CT exams, anyone with known or suspected renal insufficiency as determined by site medical personnel;
Who are in need of urgent or emergent care;
Who have any conditions that, in the opinion of the PI or designee, would interfere with the evaluation of the results or constitute a health hazard for the subject; and,
Who are unwilling to have GEHC personnel present for the CT exam.

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Wisconsin, Madison
Madison, Wisconsin, 53792

Other trials in United States

About this study

Official title: Clinical Feasibility and Evaluation of Silicon Photon Counting CT

The purpose of the study is to collect data to evaluate utility of a next generation CT system in a clinical setting.

Read the detailed description

Data collected in this study includes an assessment of image quality parameters including spatial resolution, image contrast, and noise to evaluate the product. This data and analysis will help support regulatory submission.

Conditions: Computed Tomography
Being tested: Investigational CT Scan

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Investigational CT ScanDevice
All pre-contrast testing and administration of supporting medications shall be done according to the hospital's SOC. Images will then be compared with the previously acquired imaging conducted as standard of care. The investigational scan takes between 10-30 minutes.

Study groups in NCT06769594
Study group	Role	What they receive
General		Approximately 80 subjects whose standard of care imaging involved the head/neck, chest, abdomen/bowel and/or musculoskeletal regions will be enrolled. Receives: Device: Investigational CT Scan
Cardiac		Approximately 20 subjects whose standard of care imaging involved the heart will be enrolled. Receives: Device: Investigational CT Scan

What is being measured

The primary outcome is the main question the study is designed to answer.

Data Collection
Number of investigational CT scans along with standard of care CT images
Measured: 12 months

Secondary outcomes (2)

Safety Information
Type and numbers of AEs, SAEs, and Device Deficiencies
Measured: 12 months
Assessment of Image Quality
Images created from the raw investigational CT scan data will be scored for image quality
Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

8 Apr 20256 Mar 2026

First posted10 Jan 2025
Study start8 Apr 2025
Primary completion6 Mar 2026
Study completion6 Mar 2026

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Computed TomographyStudies of the same condition, open and under way.
More trials run by GE HealthcareThe sponsor's other registered studies.
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: Observational
Observational model: Cohort
Time perspective: Cross-sectional
Enrolment: 64 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06769594
Sponsor's protocol ID: SA-000001
Status last verified: Apr 2026
First submitted: 6 Jan 2025
Last updated: 29 Apr 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
Prospective Evaluation of Next Generation CT Reconstruction (NextGenIR)
Healthy Subjects
Active, not recruitingPhase 3
Coronary Computed Tomography Study to Assess the Effect of Inclisiran in Addition to Maximally Tolerated Statin Therapy on Atherosclerotic Plaque Progression in Participants With a Diagnosis of Non-obstructive Coronary Artery Disease Without Previous Cardiovascular Events
Coronary Artery Disease
Active, not recruiting
Troponin in Acute Chest Pain to Risk Stratify and Guide EffecTive Use of Computed Tomography Coronary Angiography
Coronary Artery Disease
Recruiting
Radiotracer-Based Perfusion Imaging of Patients With Peripheral Arterial Disease
Peripheral Artery Disease, Diabetes Mellitus
RecruitingObservational study
Prospective Evaluation of High Resolution Dual Energy Computed Tomographic Imaging, Noninvasive (Liquid) Biopsies, and Minimally Invasive Surgical Surveillance for Early Detection of Mesotheliomas in Patients With BAP1 Tumor Predisposition Syndrome
Familial Cancer, BRCA1-Associated Protein-1 (BAP1) Mutations

All Computed Tomography trials

Study at a glance

From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Clinical Feasibility and Evaluation of Silicon Photon Counting CT
ClinicalTrials.gov ID: NCT06769594
Acronym / sponsor ID: SA-000001
Conditions: Computed Tomography
Study type: Observational
Recruitment status: Completed
Enrolment: 64 participants (actual)
Lead sponsor: GE HealthcareIndustry (pharma, biotech, devices)
Collaborators: University of Wisconsin, Madison
Study start: 8 Apr 2025 (actual)
Primary completion: 6 Mar 2026 (actual)
Study completion: 6 Mar 2026 (actual)
First posted: 10 Jan 2025 (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.

The purpose of the study is to collect data to evaluate utility of a next generation CT system in a clinical setting.

Detailed description

Study design

Observational model: Cohort
Time perspective: Cross-sectional
Number of arms: 2

Arm	Type	Receives
General	–	Device: Investigational CT ScanApproximately 80 subjects whose standard of care imaging involved the head/neck, chest, abdomen/bowel and/or musculoskeletal regions will be enrolled.
Cardiac	–	Device: Investigational CT ScanApproximately 20 subjects whose standard of care imaging involved the heart will be enrolled.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: The subject population will consist of adults that are 18-years of age or older, and who have undergone a prior clinically indicated imaging exam of at least one of the following anatomical areas: head, neck, heart, chest, abdomen, pelvis, and/or extremities.

Key inclusion criteria (4 listed)

Who are 18 year of age or older;
Able to sign and date the informed consent form; AND
Who have in the past 120 days or will in the future 30 days from the day of consent undergo a clinically indicated imaging exam (MRI, CT, radiograph, nuclear medicine, ultrasound, bone material density, interventional radiology procedure) of the head, neck, heart, chest, abdomen, pelvis, or extremities where images are available for this prior exam.

Key exclusion criteria (8 listed)

Subjects may be excluded from participating in study if they meet any of the following criteria:
Who are pregnant or lactating;
Who were previously enrolled in this study;
For contrast-enhanced CT exams, anyone with known or suspected allergy to iodinated contrast agents;
For contrast-enhanced CT exams, anyone with known or suspected renal insufficiency as determined by site medical personnel;

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
Investigational CT ScanAll pre-contrast testing and administration of supporting medications shall be done according to the hospital's SOC. Images will then be compared with the previously acquired imaging conducted as standard of care. The investigational scan takes between 10-30 minutes.	Device	Cardiac, General

Primary outcome

Data Collection
Time frame: 12 months
Number of investigational CT scans along with standard of care CT images

2 secondary outcomes

Safety Information
Time frame: 12 months
Assessment of Image Quality
Time frame: 12 months

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2026.
Individual participant dataSharing planned: No

Related trials for Computed Tomography

RecruitingObservational study
Prospective Evaluation of Next Generation CT Reconstruction (NextGenIR)
Healthy Subjects
Active, not recruitingPhase 3
Coronary Computed Tomography Study to Assess the Effect of Inclisiran in Addition to Maximally Tolerated Statin Therapy on Atherosclerotic Plaque Progression in Participants With a Diagnosis of Non-obstructive Coronary Artery Disease Without Previous Cardiovascular Events
Coronary Artery Disease
Active, not recruiting
Troponin in Acute Chest Pain to Risk Stratify and Guide EffecTive Use of Computed Tomography Coronary Angiography
Coronary Artery Disease
Recruiting
Radiotracer-Based Perfusion Imaging of Patients With Peripheral Arterial Disease
Peripheral Artery Disease, Diabetes Mellitus
RecruitingObservational study
Prospective Evaluation of High Resolution Dual Energy Computed Tomographic Imaging, Noninvasive (Liquid) Biopsies, and Minimally Invasive Surgical Surveillance for Early Detection of Mesotheliomas in Patients With BAP1 Tumor Predisposition Syndrome
Familial Cancer, BRCA1-Associated Protein-1 (BAP1) Mutations

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. This study is not recruiting at the moment.

MICT Global Research Manager study director

GE Healthcare

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Computed Tomography, run by GE Healthcare 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 4 inclusion and 8 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: finished, as of the sponsor's last update on 29 Apr 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.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Data Collection (time frame: 12 months). 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 NCT06769594.

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 29 Apr 2026.