Menu
Recruiting NCT07031336

Photon-counting CT in Chest Imaging

No phase Interventional COPD (Chronic Obstructive Pulmonary Disease)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Photon-counting CT, Energy-integrating CT.
Who it may be relevant to
Registry conditions: COPD (Chronic Obstructive Pulmonary Disease). Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

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).

Primary outcome measures

  • 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]
  • 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]
  • 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]
  • 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]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Other

Study locations

United States · 1 center
  • Duke University Hospital — Durham

Identifiers

NCT: NCT07031336 · PRO00117084

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗