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| Name | Class |
|---|---|
| Columbia University | OTHER |
| Taipei Veterans General Hospital, Taiwan | OTHER_GOV |
| Virginia Polytechnic Institute and State University | OTHER |
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The BR-USCAD DS Module is a computer-assisted detection and diagnosis software based on a deep learning algorithm. This retrospective, fully-crossed, multi-reader, multi-case (MRMC) study aims to compare the performances of readers without and with the aid of the Breast Ultrasound Image Reviewed with Assistance of Computer-Assisted Detection and Diagnosis System (BR-USCAD DS) in interpreting breast ultrasound images of lesions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| First session: manual review first and then review with CADx | Active Comparator | Reader Group X interpret the "Dataset A" cases in different random order without any assistance of AI first, and then interpret the "Dataset B" cases in different random order with TaiHao AI system. |
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| First session: review with CADx first and then manual review | Active Comparator | Reader Group Y interpret the "Dataset A" cases in different random order with TaiHao AI system first, and then interpret the "Dataset B" cases in different random order without any assistance of AI. |
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| Second session: manual review first and then review with CADx | Active Comparator | At least 4 weeks after first session for memory washing out. Reader Group X interpret the "Dataset A" cases in different random order with TaiHao AI system first, and then interpret the "Dataset B" cases in different random order without any assistance of AI. |
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| Second session: review with CADx first and then manual review | Active Comparator | At least 4 weeks after first session for memory washing out. Rader Group Y interpret the "Dataset A" cases in different random order without any assistance of AI first, and then interpret the "Dataset B" cases in different random order with TaiHao AI system. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Reader Group X - Session 1 | Diagnostic Test | Each rater in "Reader Group X" will interpret the "dataset A" cases in different random order without BR-USCAD DS and interpret the "dataset B" cases in different random order with BR-USCAD DS. |
| Measure | Description | Time Frame |
|---|---|---|
| Comparing the Area Under the LROC Curve | The area under the LROC curve (AUC_LROC) on the diagnosis of benign and malignant lesions was computed and compared for Aim 1 (baseline) and Arm 2 (with BU-CAD assistance) studies. | 10 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| The Reading Time Was Computed and Compared for Aim 1 (Baseline) and Arm 2 (With BU-CAD Assistance) Studies. | Each reader's reading time of a case was automatically recorded by the BU-CAD system. the average reading times of 16 readers with and without outlier reading times were compared between the aided and unaided sessions using the paired t-test. | 10 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shih Chung Lo, Ph.D. | Arlington Innovation Center: Health Research - Virginia Tech | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arlington Innovation Center: Health Research - Virginia Tech | Arlington | Virginia | 22203 | United States |
628 cases were randomly split into study datasets A and B. Each dataset had 314 cases. For each session, sub-datasets A and B were randomized within the group. Then, a reader read each sub-dataset either unaided or aided by the BU-CAD system.
Six hundred and twenty-eight cases were randomized and split into two groups (A and B) with the same number of cases (314) in each group. Sixteen readers were randomized and split into two groups (X and Y) with the same number of readers (8) in each group.
| ID | Title | Description |
|---|---|---|
| FG000 | Arm 1 | Group X readers read group A cases first unaided and then group B cases aided. At least 5 weeks later, group X readers read group B cases unaided, then group A cases aided. |
| FG001 | Arm2 | Group Y readers read group B cases first unaided and then group A cases aided. At least 5 weeks later, group Y readers read group A cases unaided, then group B cases aided. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| The 1st Study Sessions |
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| The 2st Study Sessions (5 Weeks Later) |
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| ID | Title | Description |
|---|---|---|
| BG000 | Without BU-CAD Decision Support Assistance | Group X readers read group A cases(314) first unaided and then group B cases(314) aided. At least 5 weeks later, group X readers read group B cases(314) unaided, then group A cases(314) aided. |
| BG001 | With BU-CAD Decision Support Assistance |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Comparing the Area Under the LROC Curve | The area under the LROC curve (AUC_LROC) on the diagnosis of benign and malignant lesions was computed and compared for Aim 1 (baseline) and Arm 2 (with BU-CAD assistance) studies. | Of the study breast ultrasound cases, some contained malignant lesions and some contained breast contained benign lesions. | Posted | Mean | 95% Confidence Interval | probability | 10 weeks | case | case |
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Adverse Events cannot be monitored/assessed. Because this is a retrospective reader study, not a human trial.
This is a retrospective reader study. There is no adverse events and risks.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | First Session: Manual Review First and Then Review With CADx | Each rater will interpret the "Dataset A" cases in different random order without any assistance of artificial assistance first, and then interpret the "Dataset B" cases in different random order with BR-USCAD DS. Reader Group X: Each rater in "Reader Group X" will interpret the "dataset A" cases in different random order without BR-USCAD DS and interpret the "dataset B" cases in different random order with BR-USCAD DS. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Study Director of Clinical Trials | Virginia Tech | +1 (301) 820-5225 | dcben0@gmail.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 2, 2022 | Apr 11, 2022 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D001941 | Breast Diseases |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| Reader Group Y - Session 1 | Diagnostic Test | Each rater in "Reader Group Y" will interpret the "dataset A" cases in different random order with BR-USCAD DS and interpret the "dataset B" cases in different random order without BR-USCAD DS. |
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| Reader Group X - Session 2 | Diagnostic Test | Each rater in "Reader Group X" will interpret the "dataset A" cases in different random order with BR-USCAD DS and interpret the "dataset B" cases in different random order without BR-USCAD DS. |
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| Reader Group Y - Session 2 | Diagnostic Test | Each rater in "Reader Group Y" will interpret the "dataset A" cases in different random order without BR-USCAD DS and interpret the "dataset B" cases in different random order with BR-USCAD DS. |
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| The Sensitivity, Specificity, PPV, and NPV Were Computed and Compared for Aim 1 (Baseline) and Arm 2 (With BU-CAD Assistance) Studies. | The mean sensitivity, specificity, PPV, and NPV of 16 readers were calculated and compared between the aided and unaided sessions using McNemar's test. | 10 weeks |
| NOT COMPLETED |
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Group Y readers read group B cases(314) first unaided and then group A cases(314) aided. At least 5 weeks later, group Y readers read group A cases(314) unaided, then group B(314) cases aided. |
| BG002 | Total | Total of all reporting groups |
| Participants |
| No |
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| Sex/Gender, Customized | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Secondary | The Reading Time Was Computed and Compared for Aim 1 (Baseline) and Arm 2 (With BU-CAD Assistance) Studies. | Each reader's reading time of a case was automatically recorded by the BU-CAD system. the average reading times of 16 readers with and without outlier reading times were compared between the aided and unaided sessions using the paired t-test. | Of the study breast ultrasound cases, some contained malignant lesions and some contained breast contained benign lesions. | Posted | Mean | 95% Confidence Interval | second | 10 weeks | case | case |
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| Secondary | The Sensitivity, Specificity, PPV, and NPV Were Computed and Compared for Aim 1 (Baseline) and Arm 2 (With BU-CAD Assistance) Studies. | The mean sensitivity, specificity, PPV, and NPV of 16 readers were calculated and compared between the aided and unaided sessions using McNemar's test. | Of the study breast ultrasound cases, some contained malignant lesions and some contained breast contained benign lesions. | Posted | Mean | 95% Confidence Interval | proportion | 10 weeks | case | case |
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| EG001 | First Session: Review With CADx First and Then Manual Review | Each rater will interpret the "Dataset A" cases in different random order with BR-USCAD DS first, and then interpret the "Dataset B" cases in different random order without any assistance of artificial assistance. Reader Group Y: Each rater in "Reader Group Y" will interpret the "dataset A" cases in different random order with BR-USCAD DS and interpret the "dataset B" cases in different random order without BR-USCAD DS. | 0 | 0 | 0 | 0 | 0 | 0 |
| EG002 | Second Session: Manual Review First and Then Review With CADx | At least 4 weeks after first session for memory washing out. Each rater will interpret the "Dataset A" cases in different random order without any assistance of artificial assistance first, and then interpret the "Dataset B" cases in different random order with BR-USCAD DS. Reader Group Y: Each rater in "Reader Group Y" will interpret the "dataset A" cases in different random order with BR-USCAD DS and interpret the "dataset B" cases in different random order without BR-USCAD DS. | 0 | 0 | 0 | 0 | 0 | 0 |
| EG003 | Second Session: Review With CADx First and Then Manual Review | At least 4 weeks after first session for memory washing out. Each rater will interpret the "Dataset A" cases in different random order with BR-USCAD DS first, and then interpret the "Dataset B" cases in different random order without any assistance of artificial assistance. Reader Group X: Each rater in "Reader Group X" will interpret the "dataset A" cases in different random order without BR-USCAD DS and interpret the "dataset B" cases in different random order with BR-USCAD DS. | 0 | 0 | 0 | 0 | 0 | 0 |
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| PPV |
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| NPV |
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| different in specificity |
| 0.1065 |
| 2-Sided |
| 95 |
| 0.0008 |
| 0.2122 |
| Superiority |
| McNemar | <0.05 | different in PPV | -0.0860 | 2-Sided | 95 | -0.1824 | 0.0104 | Superiority |
| McNemar | <0.05 | different in NPV | 0.0860 | 2-Sided | 95 | -0.0104 | 0.1824 | Superiority |