Quantitative Dual Energy Computed Tomography in Pulmonary Hypertension

Pulmonary Hypertension Clinical Trial

— DECTPH  

Official title:

Quantitative Dual Energy Computed Tomography in Pulmonary Hypertension "DECTPH".

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03901287
• Other study ID #: CHUBX 2018/59
• Status: Completed
• Phase: N/A
• Start date: August 2, 2019
• Est. completion date: January 15, 2021

Study information

• Verified date: March 2021
• Source: University Hospital, Bordeaux
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: January 15, 2021
• Est. primary completion date: January 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypertension
• Hypertension, Pulmonary
• Pulmonary Hypertension

Intervention

Other:
• dual energy CT scans
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)

Locations

Country	Name	City	State
France	CHU Bordeaux	Bordeaux

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Bordeaux

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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))	Baseline
Secondary	kappa coefficient	Good kappa coefficient (>0.6) for topographic evaluation of pulmonary artery segmentation	baseline
Secondary	Dice coefficient	Good Dice coefficient (>0.8) for overlap and similarity between manual (ground truth) and automatic segmentations	Baseline