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COPD (Chronic Obstructive Pulmonary Disease)Lungs and breathingDevice

What this study is

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.

What's being tested

  • Photon-counting CT

    Intervention · DEVICE

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

  • Energy-integrating CT

    Intervention · DEVICE

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

Study details

Official title
Photon-counting CT Post-processing Protocols for Robust Quantifications in Chest CT Scans
Sponsor
Duke University
Conditions
COPD (Chronic Obstructive Pulmonary Disease)
Enrolling
40 people
Starts
2025-11-14
Est. completion
2027-12-12
Design
Open-label, single group
Record
View on ClinicalTrials.gov ↗