Photon-counting CT in Chest Imaging

NCT ID: NCT07031336

Last Updated: 2025-09-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-30

Study Completion Date

2026-05-12

Brief Summary

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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.

Detailed Description

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Conditions

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COPD (Chronic Obstructive Pulmonary Disease)

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Energy-integrating and photon-counting CT scans

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.

Group Type OTHER

Photon-counting CT

Intervention Type DEVICE

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

Energy-integrating CT

Intervention Type DEVICE

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

Interventions

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Photon-counting CT

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

Intervention Type DEVICE

Energy-integrating CT

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

Intervention Type DEVICE

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Duke University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ehsan Abadi, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

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Duke University Hospital

Durham, North Carolina, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Wendy Curry

Role: CONTACT

919-668-8281

Facility Contacts

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Ehsan Abadi

Role: primary

919-684-1442

Other Identifiers

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PRO00117084

Identifier Type: -

Identifier Source: org_study_id

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