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Quantitative Dual Energy Computed Tomography in Pulmonary Hypertension (DECTPH)

Primary Purpose

Pulmonary Hypertension

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
dual energy CT scans
Sponsored by
University Hospital, Bordeaux
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Pulmonary Hypertension focused on measuring pulmonary hypertension, dual energy CT, quantification, lung perfusion, prediction

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • adults (18 years old and over)
  • Patient with PH diagnosed at right heart catheterization
  • Availability of a dual energy chest CT scans with contrast injection performed as part of standard patient workup
  • Patient's consent or authorisation for data processing.

Exclusion Criteria:

  • patient without any chest CT scan available or planned in the patient workup

Sites / Locations

  • CHU Bordeaux

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

dual energy CT

Arm Description

The procedure involves post processing and analysis of reconstructed images from dual energy CT scans available at the Bordeaux University Hospital and used in routine care, which will allow us to collect morphometric data (bronchial wall thickness and cross sectional area of small pulmonary vessels) and to assess pulmonary perfusion by studying iodine mapping and quantifying pulmonary perfusion blood volume (PVB)

Outcomes

Primary Outcome Measures

stence and the severity of PH
Prediction of the existence and the severity of PH using a qCT score combining morphometric parameters (WT(mm), CSA(mm2) and/or VSA(mm3)) and functional parameters (PVB(HU))

Secondary Outcome Measures

kappa coefficient
Good kappa coefficient (>0.6) for topographic evaluation of pulmonary artery segmentation
Dice coefficient
Good Dice coefficient (>0.8) for overlap and similarity between manual (ground truth) and automatic segmentations

Full Information

First Posted
April 1, 2019
Last Updated
March 25, 2021
Sponsor
University Hospital, Bordeaux
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1. Study Identification

Unique Protocol Identification Number
NCT03901287
Brief Title
Quantitative Dual Energy Computed Tomography in Pulmonary Hypertension
Acronym
DECTPH
Official Title
Quantitative Dual Energy Computed Tomography in Pulmonary Hypertension "DECTPH".
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
August 2, 2019 (Actual)
Primary Completion Date
January 15, 2021 (Actual)
Study Completion Date
January 15, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Bordeaux

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Pathophysiological mechanisms leading to pulmonary hypertension (PH) are complex. Quantitative computed tomography (QCT) can help us to study morphological alterations in patients with PH. These CT morphometrics are useful to predict the degree of PH severity at least in PH secondary to chronic obstructive pulmonary disease (COPD). We hypothesized that assessing lung perfusion using dual energy CT (DECT) can refine our knowledge on PH pathophysiology and help to predict PH severity irrespective of its etiology
Detailed Description
Pulmonary hypertension (PH) is a serious disease with poor prognosis and high morbidity and mortality. It is defined as an increase in mean pulmonary arterial pressure (mPAP) above or equal to 25 mmHg measured by right heart catheterization, which is an invasive technique. Computed tomography (CT) plays an important role in the classification of PH and the identification of pulmonary etiologies responsible for PH (chronic obstructive pulmonary disease (COPD), idiopathic pulmonary fibrosis...) or signs of chronic thromboembolic PH (CTEPH). Quantitative CT allows accurate analysis of the morphological changes found in PH and leading to a better understanding of the complex interactions involved (arterial and bronchial remodeling in PH secondary to COPD, inflammation etc.). Dual energy CT acquisition has shown its interest in helping to diagnose pulmonary embolism. It provides information on pulmonary perfusion by performing iodine mapping and measuring pulmonary perfusion blood volume (PVB). This project intends to study morphological and functional alterations at bronchial and vascular levels in PH patients using quantitative DECT and to examine their impact to predict existence and severity of PH irrespective of its etiology. To measure from DECT scan images, cross sectional area of small pulmonary vessels (CSA), bronchial wall thickness (WT) and pulmonary perfusion blood volume. To collect data from right heart catheterization, echocardiography, pulmonary functional tests and blood tests. All these examinations will be performed in routine care within a week after the patient is referred to our institution. Statistical analysis of these parameters could lead to a multivariate model able to predict existence and severity of PH. In addition, DECT allows the use of low energy (low Kilovoltage), which increases contrast and improves segmentation of the pulmonary arteries. Thus, peripheral pulmonary arteries and veins can be distinguishable in order to evaluate not just the sectional area of the small pulmonary vessels but also 3D volume of small pulmonary arteries (VSA). This technical modification would make it possible to refine the quantitative exploration of the vascular compartment of PH

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Hypertension
Keywords
pulmonary hypertension, dual energy CT, quantification, lung perfusion, prediction

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
dual energy CT
Arm Type
Experimental
Arm Description
The procedure involves post processing and analysis of reconstructed images from dual energy CT scans available at the Bordeaux University Hospital and used in routine care, which will allow us to collect morphometric data (bronchial wall thickness and cross sectional area of small pulmonary vessels) and to assess pulmonary perfusion by studying iodine mapping and quantifying pulmonary perfusion blood volume (PVB)
Intervention Type
Other
Intervention Name(s)
dual energy CT scans
Intervention Description
The procedure involves post processing and analysis of reconstructed images from dual energy CT scans available at the Bordeaux University Hospital and used in routine care, which will allow us to collect morphometric data (bronchial wall thickness and cross sectional area of small pulmonary vessels) and to assess pulmonary perfusion by studying iodine mapping and quantifying pulmonary perfusion blood volume (PVB)
Primary Outcome Measure Information:
Title
stence and the severity of PH
Description
Prediction of the existence and the severity of PH using a qCT score combining morphometric parameters (WT(mm), CSA(mm2) and/or VSA(mm3)) and functional parameters (PVB(HU))
Time Frame
Baseline
Secondary Outcome Measure Information:
Title
kappa coefficient
Description
Good kappa coefficient (>0.6) for topographic evaluation of pulmonary artery segmentation
Time Frame
baseline
Title
Dice coefficient
Description
Good Dice coefficient (>0.8) for overlap and similarity between manual (ground truth) and automatic segmentations
Time Frame
Baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: adults (18 years old and over) Patient with PH diagnosed at right heart catheterization Availability of a dual energy chest CT scans with contrast injection performed as part of standard patient workup Patient's consent or authorisation for data processing. Exclusion Criteria: patient without any chest CT scan available or planned in the patient workup
Facility Information:
Facility Name
CHU Bordeaux
City
Bordeaux
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

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Quantitative Dual Energy Computed Tomography in Pulmonary Hypertension

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