Computed TomographyNCT07661706
Data Collection of New Spectral CT Imaging Method
An observational study of Computed Tomography, run by GE Healthcare at 1 site in United States.
Trial summary
The purpose of the study is to collect data to evaluate utility of a next generation spectral CT system in a clinical setting. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Computed Tomography
- What is being tested?
- Research CT
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Dec 2025to Oct 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- Healthy volunteers accepted
- Adult, Older adult
Study population: The subject population will consist of adults that are 18-years of age or older who in the past 90 days or will in the future 30 days of the investigational scan undergo a clinically indicated CT exam within the St. Luke's University Hospital Network of the neck, chest, abdomen, pelvis, or extremities.
Who may be able to join
- Who are ≥18 years of age;
- Able to sign and date the informed consent form; AND,
- Who have in the past 90 days or will in the future 30 days of the investigational scan undergo a clinically indicated CT exam within the St. Luke's University Hospital Network of the neck, chest, abdomen, pelvis, or extremities.
Who cannot join
- Who are pregnant or lactating;
- Who were previously enrolled in this study;
- For planned contrast-enhanced investigational CT exams, anyone with known or suspected allergy to iodinated contrast agents;
- For planned contrast-enhanced investigational CT exams, anyone with known or suspected renal insufficiency as determined by site medical personnel;
- Who need 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; OR,
- Who are unwilling to have GEHC personnel present for the CT exam.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
St Luke's University Health Network
Bethlehem, Pennsylvania, 18015
Kyle McFadden, (484) 658-1802, Kyle.McFadden@sluhn.org
Pallav N Shah, MD
About this study
The purpose of the study is to collect data to evaluate utility of a next generation spectral CT system in a clinical setting.
Read the detailed description
Data collected in this study includes an assessment of image quality parameters to evaluate the product. This data and analysis will help support regulatory submissions.
- Conditions
- Computed Tomography
- Being tested
- Research CT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Research CTDevice
Participants will undergo a research CT on an investigational Spectral CT Imaging scanner which will be matched to their prior or scheduled SOC CT. Scans will be matched on anatomy, radiation dose, and contrast administration.
| Study group | Role | What they receive |
|---|---|---|
| Research CT | Not described Receives: Device: Research CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluable Raw Research Scans
Number of participants who research scan is deemed evaluable (i.e., no issues with participant motion or contrast administration/timing)
Measured: Through study completion, an average of 1 year
Secondary outcomes (1)
Safety Assessment
Number of Adverse Events and/or Serious Adverse Events reported.
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2026
- Study start19 Dec 2025
- Primary completionOct 2026 (estimated)
- Study completionOct 2026 (estimated)
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
- Case only
- Time perspective
- Other
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- GE Healthcare
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Brian Thomsen, Study director, GE Healthcare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07661706
- Sponsor's protocol ID
- SA-000043
- Status last verified
- Aug 2026
- First submitted
- 24 Apr 2026
- Last updated
- 26 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Data Collection of New Spectral CT Imaging Method
- ClinicalTrials.gov ID
- NCT07661706
- Acronym / sponsor ID
- SA-000043
- Conditions
- Computed Tomography
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- GE HealthcareIndustry (pharma, biotech, devices)
- Study start
- 19 Dec 2025 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 22 Jun 2026 (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 spectral CT system in a clinical setting.
Detailed description
Data collected in this study includes an assessment of image quality parameters to evaluate the product. This data and analysis will help support regulatory submissions.
Study design
- Observational model
- Case only
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Research CT | – | Device: Research CT |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The subject population will consist of adults that are 18-years of age or older who in the past 90 days or will in the future 30 days of the investigational scan undergo a clinically indicated CT exam within the St. Luke's University Hospital Network of the neck, chest, abdomen, pelvis, or extremities.
Key inclusion criteria (3 listed)
- Who are ≥18 years of age;
- Able to sign and date the informed consent form; AND,
- Who have in the past 90 days or will in the future 30 days of the investigational scan undergo a clinically indicated CT exam within the St. Luke's University Hospital Network of the neck, chest, abdomen, pelvis, or extremities.
Key exclusion criteria (7 listed)
- Who are pregnant or lactating;
- Who were previously enrolled in this study;
- For planned contrast-enhanced investigational CT exams, anyone with known or suspected allergy to iodinated contrast agents;
- For planned contrast-enhanced investigational CT exams, anyone with known or suspected renal insufficiency as determined by site medical personnel;
- Who need urgent or emergent care;
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 |
|---|---|---|
| Research CTParticipants will undergo a research CT on an investigational Spectral CT Imaging scanner which will be matched to their prior or scheduled SOC CT. Scans will be matched on anatomy, radiation dose, and contrast administration. | Device | Research CT |
Primary outcome
Evaluable Raw Research Scans
Time frame: Through study completion, an average of 1 year
Number of participants who research scan is deemed evaluable (i.e., no issues with participant motion or contrast administration/timing)
1 secondary outcome
Safety Assessment
Time frame: Through study completion, an average of 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2026.
- Individual participant dataSharing planned: No
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Healthy Subjects
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.
Brian Thomsen 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 3 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 26 Aug 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Melissa Challman, MPH, CCRP (18582213007, melissa.challman@gehealthcare.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluable Raw Research Scans (time frame: Through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Aug 2026.