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.
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.
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.
- Conditions
- Pulmonary Embolism
- 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.
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)
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.
- First posted18 Apr 2022
- Study start1 Apr 2022
- Primary completion1 Apr 2022
- Study completion14 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary EmbolismStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 5,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- OncoRadiomics
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Centre Hospitalier Universitaire de Liege
- Responsible party
- Sponsor
- Investigators
- Paul Meunier, PhD, Principal investigator, CHU of Liege
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
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- External Validation of a Deep Learning Based Model for Pulmonary Embolism Detection on Chest CT Scans
- ClinicalTrials.gov ID
- NCT05333042
- Acronym / sponsor ID
- 0156_PE detector validation
- Conditions
- Pulmonary Embolism
- Keywords
- AI, Deep learning, Pulmonary embolism, CT scan
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5,000 participants (actual)
- Lead sponsor
- OncoRadiomicsIndustry (pharma, biotech, devices)
- Collaborators
- Centre Hospitalier Universitaire de Liege
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 1 Apr 2022 (actual)
- Study completion
- 14 Jul 2022 (actual)
- First posted
- 18 Apr 2022 (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.
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.
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.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (3 listed)
- Opposition to participate to retrospective clinical trial
- Severe respiratory and hard beam artifacts
- Patients already included in a clinical trial
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The detection performances of the deep learning model
Time frame: baseline
Area under the curve (AUC), sensitivity and specificity for the deep learning model in the identification of pulmonary embolism on enhanced chest CT scan
1 secondary outcome
Comparison of performances of the deep learning model on CTPA and enhanced CT scans
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 21 Sep 2022.
- Individual participant dataSharing planned: No
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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.
Paul Meunier, PhD principal investigator
CHU of Liege
1 site in 1 country: see every site and its status.
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.