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NCT Number: NCT07031336

Photon-counting CT in Chest Imaging

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.

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Key information

Conditions

COPD (Chronic Obstructive Pulmonary Disease) Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Duke University Hospital

Durham, North Carolina, 27705, United States

Location status: Recruiting

Location contact

Ehsan Abadi

CONTACT

[email protected]

919-684-1442

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Photon-counting CT

Device

The participants will receive a photon-counting CT scan as part of this protocol.

Energy-integrating CT

Device

The participants will receive an energy-integrating CT scan as part of the main study (NCT00608764).

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Wendy Curry

CONTACT

[email protected]

919-668-8281

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Official study title

Photon-counting CT Post-processing Protocols for Robust Quantifications in Chest CT Scans

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jun 22, 2025
Registry last updated
Jan 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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