- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05963945
Multi-Reader Retrospective Study Examining Carebot AI CXR 2.0.21-v2.01 Implementation in Everyday Radiology Clinical Practice
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
In the period between October 18th, 2022, and November 17th, 2022, anonymized chest X-ray images of patients were collected at the Radiodiagnostic Department of the Havířov Hospital, p.o. The collection process involved utilizing the CloudPACS imaging and archiving system provided by OR-CZ spol. s r.o.
The collected X-ray images were subjected to the proposed DLAD (Carebot AI CXR) for analysis. Subsequently, the DLAD's performance was compared with the standard clinical practice, where radiologists assessed the CXR images in the simulated hospital setting with access to standard viewing tools (e.g., pan, zoom, WW/WL) and were given an unlimited amount of time to complete the review. Each radiologist determined the presence or absence of 7 indicated radiological findings, including atelectasis (ATE), consolidation (CON), pleural effusion (EFF), pulmonary lesion (LES), subcutaneous emphysema (SCE), cardiomegaly (CMG), and pneumothorax (PNO).
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Havířov, Czechia, 73601
- Nemocnice Havířov, p. o.
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Patient's Sex Female: 480 (50.21 %) Male: 474 (49.58 %) Unspecified: 2 (0.21 %)
Patient's Age 18-30: 58 (6.07 %) 31-50: 163 (17.05 %) 51-70: 366 38.28 %) 70+: 369 (38.60 %)
Description
Inclusion Criteria:
- Hospital patients > 18 years who were referred for chest radiography October 18th, 2022, and November 17th, 2022 at the Radiodiagnostic Department of the Havířov Hospital, p.o.
Exclusion Criteria:
- Patients < 18 years
- Chest X-ray images in lateral positions
- Duplicated chest X-ray images
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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Retrospective collection for the period October 18th, 2022, and November 17th, 2022
A total of 1,073 chest X-rays were acquired within the specified period at the department.
The data collection remained intact and unaffected throughout the testing phase, ensuring the integrity of the dataset.
The collected sample accurately represents the prevalence of findings within the observed population.
After excluding ineligible studies such as X-rays from patients under 18 years of age, lateral projection X-rays, and scans of insufficient quality, a total of 956 relevant CXRs were identified for further assessment.
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The proposed DLAD (Carebot AI CXR) is a deep learning-based medical device designed to assist radiologists in interpreting chest X-ray images acquired in anteroposterior (AP) or posteroanterior (PA) projection.
By employing advanced deep learning algorithms, this solution enables automatic detection of abnormal findings by analyzing visual patterns associated with specific conditions.
The targeted abnormalities include atelectasis (ATE), consolidation (CON), pleural effusion (EFF), pulmonary lesion (LES), subcutaneous emphysema (SCE), cardiomegaly (CMG), and pneumothorax (PNO).
The DLAD functions as a prediction algorithm complemented by various application peripherals, such as web-based communication tools, DICOM file conversion capabilities, and storage and reporting libraries supporting both DICOM Structured Report and DICOM Presentation State formats.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Performance test
Time Frame: March 2023
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The primary objective is to evaluate the performance parameters of the proposed DLAD (Carebot AI CXR) in comparison to individual radiologists.
The performance test includes sensitivity and specificity, positive and negative likelihood ratio, and positive and negative predictive value.
The aforementioned parameters are statistically compared using confidence intervals (CI) and p-Values.
The comparison procedure consists of two steps: a global hypothesis test is conducted to determine whether there are significant differences between DLAD and radiologists.
If the global hypothesis test yields a significant result, individual hypothesis tests are performed.
Additionally, multiple comparison methods, such as McNemar with continuity correction for Se and Sp, Holm method for LRs, and weighted generalized score statistics for PVs, are applied to control the overall error rate.
All tests are performed as two-tailed tests at the 5% significance level.
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March 2023
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Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- KVAK, Daniel, Anna CHROMCOVÁ, Petra OVESNÁ, Jakub DANDÁR, Marek BIROŠ, Robert HRUBÝ, Daniel DUFEK a Marija PAJDAKOVIĆ. Can Deep Learning Reliably Recognize Abnormality Patterns on Chest X-rays? A Multi-Reader Study Examining One Month of AI Implementation in Everyday Radiology Clinical Practice. arXiv. 2023, 2305.10116, 26 s.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Heart Diseases
- Cardiovascular Diseases
- Respiratory Tract Diseases
- Neoplasms
- Lung Diseases
- Neoplasms by Site
- Pleural Diseases
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Pathological Conditions, Anatomical
- Lung Neoplasms
- Hypertrophy
- Pneumothorax
- Pulmonary Atelectasis
- Emphysema
- Multiple Pulmonary Nodules
- Cardiomegaly
- Pleural Effusion
- Solitary Pulmonary Nodule
- Subcutaneous Emphysema
Other Study ID Numbers
- 00002
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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