COPD (Chronic Obstructive Pulmonary Disease)NCT07031336
Photon-counting CT in Chest Imaging
A study testing Photon-counting CT and Energy-integrating CT in people with COPD (Chronic Obstructive Pulmonary Disease), run by Duke University at 1 site in United States.
Trial summary
Purpose and objective: This project aims to evaluate photon-counting computed tomography (PCCT) quantitative accuracy using COPDGene subjects. The goal is to establish acquisition protocols for PCCT scans with proper post-processing (e.g., reconstruction parameters and harmonization techniques) that enable… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- COPD (Chronic Obstructive Pulmonary Disease)
- What is being tested?
- Photon-counting CT and Energy-integrating CT
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Nov 2025to 12 Dec 2027
- Phase
- Interventional
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- This study recruit from the Duke-COPDGene Phase 4 study. All participants from this cohort is eligible and they will be included if they consent.
Who cannot join
- This study recruit from the Duke-COPDGene Phase 4 study. All participants from this cohort is eligible and they will be included if they consent.
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
Duke University Hospital
Durham, North Carolina, 27705
Ehsan Abadi, 919-684-1442, ehsan.abadi@duke.edu
About this study
Official title: Photon-counting CT Post-processing Protocols for Robust Quantifications in Chest CT Scans
Purpose and objective: This project aims to evaluate photon-counting computed tomography (PCCT) quantitative accuracy using COPDGene subjects. The goal is to establish acquisition protocols for PCCT scans with proper post-processing (e.g., reconstruction parameters and harmonization techniques) that enable reproducible measurements of emphysema metrics (e.g., Perc15, LAA-950, HU accuracy) and airways (Pi10, WA%) in the lungs.
Study activities and population group: The study will recruit subjects from a current study at Duke (COPDGene Phase 4, Pro00113442). Here are the aims:
Read more
- The research team will request consent from participants to acquire PCCT scans at their Phase 4 COPDGene visit. Scans will be performed using a PCCT-specific protocol.
- Reconstruct the PCCT images with multiple post-acquisition parameter settings. Apply harmonization techniques that are recently developed by the investigators of this study.
Data analysis:
- Identify the reconstruction and harmonization conditions that enable reproducible measurements of emphysema metrics (perc15, LAA-950, HU accuracy) and airways (Pi10, WA%), when compared to the counterpart EICT scans.
- Demonstrate the non-inferiority and potentially improved capabilities of PCCT scans in cross-sectional and longitudinal studies.
Risk/safety issues:
The participants are asked to get an additional CT scan with a PCCT scanner at their COPDGene Phase 4 visit. This additional CT scan will be done using an inspiratory chest protocol with a total of 3 mGy (~1.5 mSv) radiation dose. This is roughly equivalent of 6 month of background radiation. Women who are pregnant will not have a chest CT scan done until they are confirmed to be not pregnant.
- Being tested
- Photon-counting CT, Energy-integrating CT
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Photon-counting CTDevice
The participants will receive a photon-counting CT scan as part of this protocol.
Energy-integrating CTDevice
The participants will receive an energy-integrating CT scan as part of the main study (NCT00608764).
| Study group | Role | What they receive |
|---|---|---|
| Energy-integrating and photon-counting CT scans | Other | The participants will receive an energy-integrating CT scan as part of the main study (NCT00608764) and a photon-counting CT scan as part of this protocol. Receives: Device: Photon-counting CT; Device: Energy-integrating CT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quantitative reproducibility as measured by consistency of Perc15 (15th Percentile of lung CT histogram in Hounsfield Unit)
Perc15 will be measured from CT images, and its reproducibility will be quantified. The reproducibility of the measurements is defined as the least significant difference between two consecutive measurements across imaging conditions using the within-subject standard deviation method. The 95% confidence interval for reproducibility will be generated using a bootstrapping method with 5000 samples.
Measured: Day of Study Visit, approximately 30 minutes
Quantitative reproducibility as measured by consistency of LAA-950 (Percentage of CT lung voxels below -950 Hounsfield Units)
LAA-950 will be measured from CT images, and its reproducibility will be quantified. The reproducibility of the measurements is defined as the least significant difference between two consecutive measurements across imaging conditions using the within-subject standard deviation method. The 95% confidence interval for reproducibility will be generated using a bootstrapping method with 5000 samples.
Measured: Day of Study Visit, approximately 30 minutes
Quantitative reproducibility as measured by consistency of WA% (proportion of the airway wall area to the total airway area)
WA% will be measured from CT images, and its reproducibility will be quantified. The reproducibility of the measurements is defined as the least significant difference between two consecutive measurements across imaging conditions using the within-subject standard deviation method. The 95% confidence interval for reproducibility will be generated using a bootstrapping method with 5000 samples.
Measured: Day of Study Visit, approximately 30 minutes
Quantitative reproducibility as measured by consistency of Pi10 (square root of airway wall area for a hypothetical airway with a 10 mm lumen perimeter)
Pi10 will be measured from CT images, and its reproducibility will be quantified. The reproducibility of the measurements is defined as the least significant difference between two consecutive measurements across imaging conditions using the within-subject standard deviation method. The 95% confidence interval for reproducibility will be generated using a bootstrapping method with 5000 samples.
Measured: Day of Study Visit, approximately 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2025
- Study start14 Nov 2025
- Primary completion12 Dec 2026 (estimated)
- Study completion12 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPD (Chronic Obstructive Pulmonary Disease)Studies of the same condition, open and under way.
- More trials run by Duke UniversityThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ehsan Abadi, Ph.D., Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07031336
- Sponsor's protocol ID
- PRO00117084
- Status last verified
- Jun 2026
- First submitted
- 2 Jun 2025
- 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
- Photon-counting CT Post-processing Protocols for Robust Quantifications in Chest CT Scans
- ClinicalTrials.gov ID
- NCT07031336
- Acronym / sponsor ID
- PRO00117084
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 14 Nov 2025 (actual)
- Primary completion
- 12 Dec 2026 (estimated)
- Study completion
- 12 Dec 2027 (estimated)
- First posted
- 22 Jun 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.
Purpose and objective: This project aims to evaluate photon-counting computed tomography (PCCT) quantitative accuracy using COPDGene subjects. The goal is to establish acquisition protocols for PCCT scans with proper post-processing (e.g., reconstruction parameters and harmonization techniques) that enable reproducible measurements of emphysema metrics (e.g., Perc15, LAA-950, HU accuracy) and airways (Pi10, WA%) in the lungs.
Study activities and population group: The study will recruit subjects from a current study at Duke (COPDGene Phase 4, Pro00113442). Here are the aims:
- The research team will request consent from participants to acquire PCCT scans at their Phase 4 COPDGene visit. Scans will be performed using a PCCT-specific protocol.
- Reconstruct the PCCT images with multiple post-acquisition parameter settings. Apply harmonization techniques that are recently developed by the investigators of this study.
Data analysis:
- Identify the reconstruction and harmonization conditions that enable reproducible measurements of emphysema metrics (perc15, LAA-950, HU accuracy) and airways (Pi10, WA%), when compared to the counterpart EICT scans.
- Demonstrate the non-inferiority and potentially improved capabilities of PCCT scans in cross-sectional and longitudinal studies.
Risk/safety issues:
The participants are asked to get an additional CT scan with a PCCT scanner at their COPDGene Phase 4 visit. This additional CT scan will be done using an inspiratory chest protocol with a total of 3 mGy (~1.5 mSv) radiation dose. This is roughly equivalent of 6 month of background radiation. Women who are pregnant will not have a chest CT scan done until they are confirmed to be not pregnant.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Energy-integrating and photon-counting CT scans | Other | Device: Photon-counting CT, Device: Energy-integrating CTThe participants will receive an energy-integrating CT scan as part of the main study (NCT00608764) and a photon-counting CT scan as part of this protocol. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- This study recruit from the Duke-COPDGene Phase 4 study. All participants from this cohort is eligible and they will be included if they consent.
Key exclusion criteria (1 listed)
- This study recruit from the Duke-COPDGene Phase 4 study. All participants from this cohort is eligible and they will be included if they consent.
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 |
|---|---|---|
| Photon-counting CTThe participants will receive a photon-counting CT scan as part of this protocol. | Device | Energy-integrating and photon-counting CT scans |
| Energy-integrating CTThe participants will receive an energy-integrating CT scan as part of the main study (NCT00608764). | Device | Energy-integrating and photon-counting CT scans |
Primary outcome
Quantitative reproducibility as measured by consistency of Perc15 (15th Percentile of lung CT histogram in Hounsfield Unit)
Time frame: Day of Study Visit, approximately 30 minutes
Perc15 will be measured from CT images, and its reproducibility will be quantified. The reproducibility of the measurements is defined as the least significant difference between two consecutive measurements across imaging conditions using the within-subject standard deviation method. The 95% confidence interval for reproducibility will be generated using a bootstrapping method with 5000 samples.
Quantitative reproducibility as measured by consistency of LAA-950 (Percentage of CT lung voxels below -950 Hounsfield Units)
Time frame: Day of Study Visit, approximately 30 minutes
LAA-950 will be measured from CT images, and its reproducibility will be quantified. The reproducibility of the measurements is defined as the least significant difference between two consecutive measurements across imaging conditions using the within-subject standard deviation method. The 95% confidence interval for reproducibility will be generated using a bootstrapping method with 5000 samples.
Quantitative reproducibility as measured by consistency of WA% (proportion of the airway wall area to the total airway area)
Time frame: Day of Study Visit, approximately 30 minutes
WA% will be measured from CT images, and its reproducibility will be quantified. The reproducibility of the measurements is defined as the least significant difference between two consecutive measurements across imaging conditions using the within-subject standard deviation method. The 95% confidence interval for reproducibility will be generated using a bootstrapping method with 5000 samples.
Quantitative reproducibility as measured by consistency of Pi10 (square root of airway wall area for a hypothetical airway with a 10 mm lumen perimeter)
Time frame: Day of Study Visit, approximately 30 minutes
Pi10 will be measured from CT images, and its reproducibility will be quantified. The reproducibility of the measurements is defined as the least significant difference between two consecutive measurements across imaging conditions using the within-subject standard deviation method. The 95% confidence interval for reproducibility will be generated using a bootstrapping method with 5000 samples.
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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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.
Ehsan Abadi, Ph.D. principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Photon-counting CT and Energy-integrating CT in people with COPD (Chronic Obstructive Pulmonary Disease), run by Duke University 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 1 inclusion and 1 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 Wendy Curry (919-668-8281, wendy.curry@duke.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quantitative reproducibility as measured by consistency of Perc15 (15th Percentile of lung CT histogram in Hounsfield Unit) (time frame: Day of Study Visit, approximately 30 minutes). The study lists 4 primary outcomes in all. 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.