Radiation ProtectionCT-DACENCT06691659
Next-Generation Photon-Counting CT Technology: Development and Clinical Evaluation
An observational study of Radiation Protection and Image Enhancement, run by University of Pennsylvania at 1 site in United States.
Trial summary
This project aims to develop and evaluate a next-generation photon-counting CT prototype, and assess whether next-generation photon-counting CT--which enables reduced radiation dose, high spatial resolution, and spectral imaging--would facilitate improved diagnostic performance for abdominal, cardiothoracic… Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Radiation Protection, Image Enhancement
- What is being tested?
- CT-DACE
- How many people
- 250 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Nov 2024to 30 Nov 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 to 89 years
- All sexes
- Adult, Older adult
Study population: Recruited patients are scheduled to undergo a routine CT scan (with or without contrast) at the Perelman Center for Advanced Medicine. Patients in the study will undergo abdominal, cardiovascular, chest, musculoskeletal, and neuroimaging scans. The design involves 50 participants per body region to gather preliminary data and assess diagnostic benefits for future research and clinical translation. This a total of 250 patients for the initial study.
Who may be able to join
- Age 18 to 89.
- Participants must be informed of the investigational nature of this study and be willing to provide written informed consent and participate in this study in accordance with institutional and federal guidelines prior to study-specific procedures.
- Not pregnant (based on attestation)
Who cannot join
- Pregnant women will not be included. All females of childbearing potential must attest that they are not pregnant before CT imaging.
- Participants with a known contrast allergy.
- Any current medical condition, illness, or disorder, as assessed by medical record review and/or self-reported, that is considered by a physician investigator to be a condition that could compromise participant safety or successful participation in the study.
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
University of Pennsylvania - Center for Advanced Computed Tomography Imaging Services (CACTIS)
Philadelphia, Pennsylvania, 19104
Erin Schubert, 215-573-6569
Hannah Straughn, 443-739-4971
About this study
This project aims to develop and evaluate a next-generation photon-counting CT prototype, and assess whether next-generation photon-counting CT--which enables reduced radiation dose, high spatial resolution, and spectral imaging--would facilitate improved diagnostic performance for abdominal, cardiothoracic, musculoskeletal, and neuroimaging.
Read the detailed description
This protocol aims to assess the diagnostic benefits of a next-generation Photon-Counting Computed Tomography (PCCT) system in patients undergoing routine CT imaging.
Recruitment will be conducted among patients scheduled for CT scans (with or without contrast agent) at the Perelman Center for Advanced Medicine. Patients in the study will undergo abdominal, cardiovascular, chest, musculoskeletal, and neuroimaging scans.
The design involves 50 participants per body region to gather preliminary data and assess diagnostic benefits for future research and clinical translation.
This a total of 250 patients for the initial study.
Analyses will be conducted as needed, based on the specific validation or quantitative measures required for each clinical CT scan. This study will involve three radiologists for each cohort, selected based on their training in the specific anatomical region of interest, analyzing images from PCCT scanning. They will interpret both conventional CT slices and the additional spectral and high-resolution data provided by the PCCT. The images will be reviewed on a state-of-the-art workstation with a high-resolution monitor. Performance metrics will be set individually for each anatomical region.
- Conditions
- Radiation Protection, Image Enhancement
- Being tested
- CT-DACE
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CT-DACEDiagnostic test
Photon Counting CT scan
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Outcome Measure
In this clinical study evaluating a photon-counting computed tomography (CT) scanner, the Primary Outcome Measures include image quality assessed by signal-to-noise ratio, contrast-to-noise ratio, and resolution via edge response function, as well as diagnostic accuracy determined by radiologist interpretation compared to gold-standard diagnostic methods when available from previous scans.
For each body region, image data will be subjectively evaluated for image quality using a Likert scale assessing overall image quality, presence of artifacts, and diagnostic adequacy for the specific clinical indication.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2024
- Study start19 Nov 2024
- Primary completion30 Nov 2026 (estimated)
- Study completion30 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Radiation ProtectionStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe 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
- Other
- Time perspective
- Prospective
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- Canon Medical Systems, USA
- Responsible party
- Sponsor
- Investigators
- Peter B Noel, PhD, Principal investigator, UPENN Radiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06691659
- Sponsor's protocol ID
- 856690
- Acronym
- CT-DACE
- Status last verified
- Oct 2025
- First submitted
- 11 Nov 2024
- Last updated
- 14 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Next-Generation Photon-Counting CT Technology: Development and Clinical Evaluation
- ClinicalTrials.gov ID
- NCT06691659
- Acronym / sponsor ID
- CT-DACE / 856690
- Conditions
- Radiation Protection, Image Enhancement
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- Canon Medical Systems, USA
- Study start
- 19 Nov 2024 (actual)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 15 Nov 2024 (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.
This project aims to develop and evaluate a next-generation photon-counting CT prototype, and assess whether next-generation photon-counting CT--which enables reduced radiation dose, high spatial resolution, and spectral imaging--would facilitate improved diagnostic performance for abdominal, cardiothoracic, musculoskeletal, and neuroimaging.
Detailed description
This protocol aims to assess the diagnostic benefits of a next-generation Photon-Counting Computed Tomography (PCCT) system in patients undergoing routine CT imaging.
Recruitment will be conducted among patients scheduled for CT scans (with or without contrast agent) at the Perelman Center for Advanced Medicine. Patients in the study will undergo abdominal, cardiovascular, chest, musculoskeletal, and neuroimaging scans.
The design involves 50 participants per body region to gather preliminary data and assess diagnostic benefits for future research and clinical translation.
This a total of 250 patients for the initial study.
Analyses will be conducted as needed, based on the specific validation or quantitative measures required for each clinical CT scan. This study will involve three radiologists for each cohort, selected based on their training in the specific anatomical region of interest, analyzing images from PCCT scanning. They will interpret both conventional CT slices and the additional spectral and high-resolution data provided by the PCCT. The images will be reviewed on a state-of-the-art workstation with a high-resolution monitor. Performance metrics will be set individually for each anatomical region.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Recruited patients are scheduled to undergo a routine CT scan (with or without contrast) at the Perelman Center for Advanced Medicine. Patients in the study will undergo abdominal, cardiovascular, chest, musculoskeletal, and neuroimaging scans. The design involves 50 participants per body region to gather preliminary data and assess diagnostic benefits for future research and clinical translation. This a total of 250 patients for the initial study.
Key inclusion criteria (3 listed)
- Age 18 to 89.
- Participants must be informed of the investigational nature of this study and be willing to provide written informed consent and participate in this study in accordance with institutional and federal guidelines prior to study-specific procedures.
- Not pregnant (based on attestation)
Key exclusion criteria (3 listed)
- Pregnant women will not be included. All females of childbearing potential must attest that they are not pregnant before CT imaging.
- Participants with a known contrast allergy.
- Any current medical condition, illness, or disorder, as assessed by medical record review and/or self-reported, that is considered by a physician investigator to be a condition that could compromise participant safety or successful participation in the study.
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 |
|---|---|---|
| CT-DACEPhoton Counting CT scan | Diagnostic test | – |
Primary outcome
Primary Outcome Measure
Time frame: 24 months
In this clinical study evaluating a photon-counting computed tomography (CT) scanner, the Primary Outcome Measures include image quality assessed by signal-to-noise ratio, contrast-to-noise ratio, and resolution via edge response function, as well as diagnostic accuracy determined by radiologist interpretation compared to gold-standard diagnostic methods when available from previous scans. For each body region, image data will be subjectively evaluated for image quality using a Likert scale assessing overall image quality, presence of artifacts, and diagnostic adequacy for the specific clinical indication.
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 14 Oct 2025.
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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.
Peter B Noel, PhD principal investigator
UPENN Radiology
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 Radiation Protection and Image Enhancement, run by University of Pennsylvania 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 3 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 14 Oct 2025. 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 Erin Schubert (215-573-6569, erin.schubert@pennmedicine.upenn.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Outcome Measure (time frame: 24 months). 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 14 Oct 2025.