Pulmonary HypertensionDECTPHNCT03901287
Quantitative Dual Energy Computed Tomography in Pulmonary Hypertension
A study testing dual energy CT scans in people with Pulmonary Hypertension, run by University Hospital, Bordeaux at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Pulmonary Hypertension
- What is being tested?
- dual energy CT scans
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 2 Aug 2019to 15 Jan 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- patient without any chest CT scan available or planned in the patient workup
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Quantitative Dual Energy Computed Tomography in Pulmonary Hypertension "DECTPH".
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
Read the 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
- Conditions
- Pulmonary Hypertension
- Being tested
- dual energy CT scans
- Keywords
- pulmonary hypertension, dual energy CT, quantification, lung perfusion, prediction
- Medical subject headings
- Hypertension, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dual energy CT scansOther
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)
| Study group | Role | What they receive |
|---|---|---|
| dual energy CT | Experimental | 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) Receives: Other: dual energy CT scans |
What is being measured
The primary outcome is the main question the study is designed to answer.
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))
Measured: Baseline
Secondary outcomes (2)
kappa coefficient
Good kappa coefficient (>0.6) for topographic evaluation of pulmonary artery segmentation
Measured: baseline
Dice coefficient
Good Dice coefficient (>0.8) for overlap and similarity between manual (ground truth) and automatic segmentations
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2019
- Study start2 Aug 2019
- Primary completion15 Jan 2021
- Study completion15 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary HypertensionStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03901287
- Sponsor's protocol ID
- CHUBX 2018/59
- Other IDs
- 2019-A00335-52
- Acronym
- DECTPH
- Status last verified
- Mar 2021
- First submitted
- 1 Apr 2019
- Last updated
- 29 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantitative Dual Energy Computed Tomography in Pulmonary Hypertension "DECTPH".
- ClinicalTrials.gov ID
- NCT03901287
- Acronym / sponsor ID
- DECTPH / CHUBX 2018/59
- Conditions
- Pulmonary Hypertension
- Keywords
- pulmonary hypertension, dual energy CT, quantification, lung perfusion, prediction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 2 Aug 2019 (actual)
- Primary completion
- 15 Jan 2021 (actual)
- Study completion
- 15 Jan 2021 (actual)
- First posted
- 3 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| dual energy CT | Experimental | Other: dual energy CT scansThe 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) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- patient without any chest CT scan available or planned in the patient workup
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| dual energy CT scansThe 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) | Other | dual energy CT |
Primary outcome
stence and the severity of PH
Time frame: Baseline
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))
2 secondary outcomes
kappa coefficient
Time frame: baseline
Dice coefficient
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2026.
- Individual participant dataSharing planned: No
Related trials for Pulmonary Hypertension
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Not yet recruitingPhase 2
Study of Treprostinil Administered Via Soft Mist Inhaler (SMI) in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Active, not recruitingPhase 1
A Pilot Study of Microbiota Transplant With Antibiotic Preconditioning and Fiber Supplementation in Pulmonary Arterial Hypertension (GUT RESTORE-PAH)
Pulmonary Arterial Hypertension
RecruitingObservational study
Natural History Study of Biomarkers in Pulmonary Arterial Hypertension
Pulmonary Disease, Pulmonary Hypertension
Active, not recruitingPhase 1
Study of Intravenous ZMA001 in Healthy Subjects
Pulmonary Arterial Hypertension PAH
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing dual energy CT scans in people with Pulmonary Hypertension, run by University Hospital, Bordeaux at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
stence and the severity of PH (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2026.