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Photon-counting CT in Chest Imaging

NCT07031336 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2026-01-28

No results posted yet for this study

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 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.

Conditions

  • COPD (Chronic Obstructive Pulmonary Disease)

Interventions

DEVICE

Photon-counting CT

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

DEVICE

Energy-integrating CT

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

Sponsors & Collaborators

Principal Investigators

  • Ehsan Abadi, Ph.D. · Duke University

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-11-14
Primary Completion
2026-05-12
Completion
2026-05-12
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07031336 on ClinicalTrials.gov