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 ↗
Who can join
Sex ALLHealthy volunteers Not acceptedYou may qualify if
- 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.
You can't join if
- 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.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openDuke University Hospital
Durham, North Carolina, United States
- Ehsan Abadi · Contact919-684-1442ehsan.abadi@duke.edu
Recruiting
Study team
Sponsor
Duke University
Study ID PRO00117084
Principal investigator
Ehsan Abadi, Ph.D.
Duke University
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.