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Pulmonary EmbolismNCT05333042

External Validation of a Deep Learning Based Model for Pulmonary Embolism Detection on Chest CT Scans

An observational study of Pulmonary Embolism, run by OncoRadiomics at 1 site in Belgium.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The scope of this study is the external validation of an explainable deep learning-based classifier for the diagnosis and detection of pulmonary embolism in computed tomography pulmonary angiography (CTPA) and contrast enhanced CT scans. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Pulmonary Embolism
How many people
5,000 participants
Where
1 siteBelgium
Study dates
1 Apr 2022to 14 Jul 2022
Phase
Observational
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: The study population is composed of participants who underwent an enhanced chest CT scan for screening purposes for the suspicion of pulmonary embolism

Who may be able to join

  • Any patient that has benefit from contrast enhanced CT scan for any clinical reason
  • Availability of contrast enhanced images with standard reconstruction kernel and at mediastinal window

Who cannot join

  • Opposition to participate to retrospective clinical trial
  • Severe respiratory and hard beam artifacts
  • Patients already included in a clinical trial

Trial locations and contacts

1 site in 1 country.

Belgium1 site
  • Hospital Center Universitaire De Liège

    Liège, 4000

Other trials in Belgium

About this study

The scope of this study is the external validation of an explainable deep learning-based classifier for the diagnosis and detection of pulmonary embolism in computed tomography pulmonary angiography (CTPA) and contrast enhanced CT scans.

Read the detailed description

Pulmonary embolism (PE) is a potentially fatal disease if not promptly diagnosed and treated. Chest CTPA remains the gold standard for diagnosis nowadays, but PE can also be incidentally found on enhanced CT scans. Most CTPA exams are performed in clinics in case of suspicion of PE in urgent conditions, whereas a minority is performed for conditions of suspicious or validated chronic pulmonary thromboembolism, a disease frequently overlooked on CT scans but affected by high morbidity and poor prognosis if left untreated. Thus methods to expedite and automatize the recognition of emboli within pulmonary vessels have the potential of becoming an important support in clinical practice, enabling the better triage of urgent cases of PE and an increased sensitivity in the identification of patients with chronic pulmonary thromboembolism. Based on these clinical needs, a deep learning-based model for the detection of pulmonary embolism has been developed on CTPA scans. The model was based on 2D ResNext50 architecture and was trained and validated using a multicentric open source dataset composed of 7169 patients. From these retrospective data, 85,000 slices positive for PE and 123,428 negative for PE were extracted for training. For internal validation, 9,922 slices were used for each class. The model was initially externally validated at the patient-level using a dataset of 156 adult patients from 3 different public sources, with all emboli segmented by at least one experienced radiologist. To gain insight into the model predictions, activation maps were extracted using the Grad-CAM method. Comparing these maps with the ground truth (GT) segmentations, it was determined if the activated regions corresponded to regions of PE by computing the percentage of GT PE that was activated and the percentage of activated regions corresponding to GT PE. The PE classification model reached an area under the curve (AUC) of 0.86 [0.800-0.919], a sensitivity of 82.68 % [75.16 - 88.27] and a specificity of 79.31 % [61.61 - 90.15] on the external validation set. However, these results have been obtained in an unbalanced external validation cohort (127 PE positive against 29 PE negative patients), thus it is very important to assess the model performances also in a more balanced patients cohort, representing the real clinical incidence of PE (between 12 and 22%). For this reason the scope of the present study is to collect an external validation cohort representative of the real clinical reality, including both CTPA and enhanced CT scans, with a more balanced percentage of positive and negative PE cases. Moreover, the performances of the model will be compared between enhanced CT and CTPA scans.

Keywords
AI, Deep learning, Pulmonary embolism, CT scan
Medical subject headings
Pulmonary Embolism

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The detection performances of the deep learning model

    Area under the curve (AUC), sensitivity and specificity for the deep learning model in the identification of pulmonary embolism on enhanced chest CT scan

    Measured: baseline

Secondary outcomes (1)
  1. Comparison of performances of the deep learning model on CTPA and enhanced CT scans

    Area under the curve (AUC), sensitivity and specificity for the deep learning model in the identification of pulmonary embolism on enhanced chest CT scan compared to the CTPA scans

    Measured: baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Apr 2022
  2. Study start1 Apr 2022
  3. Primary completion1 Apr 2022
  4. Study completion14 Jul 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Retrospective
Enrolment
5,000 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05333042
Sponsor's protocol ID
0156_PE detector validation
Status last verified
Apr 2022
First submitted
11 Apr 2022
Last updated
21 Sep 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Pulmonary Embolism, run by OncoRadiomics at 1 site in Belgium.

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 2 inclusion and 3 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 21 Sep 2022. 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 Belgium. 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?

The detection performances of the deep learning model (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 21 Sep 2022.

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