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| ID | Type | Description | Link |
|---|---|---|---|
| IRBd20-090 | Other Identifier | IRB NKI-AVL |
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| Name | Class |
|---|---|
| The Netherlands Cancer Institute | OTHER |
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This reader study aims at assessing whether the radiologist aided with AI software has at least a non-inferior performance than without AI assistance in detecting brain metastases.
200 retrospective MRI images will be included in the study with 100 positive and 100 negative exams.
Assessment will be completed by 12 readers with varying level of experience. This is a Retrospective Multiple-Reader Multiple-Case (MRMC) randomised study.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Brain Metastasis AI | Device | There will be no intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Detection accuracy | Demonstrate that the accuracy for detecting brain metastases by radiologists on MRI using the software (AIDED) is at least non-inferior to that of radiologists not using the software (UNAIDED). | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Reading time | Demonstrate that the AIDED radiologists reading time for detecting brain metastases is significantly lower than for UNAIDED radiologists. | 3 months |
| Inter-reader agreement | Demonstrate that AIDED reading reduces detection variation between observers/readers in brain metastasis detection. |
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Inclusion Criteria:
Exclusion Criteria:
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Brain Metastasis
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Netherlands Cancer Institute | Amsterdam | Netherlands |
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| ID | Term |
|---|---|
| D001932 | Brain Neoplasms |
| ID | Term |
|---|---|
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| 3 months |
| D001927 |
| Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |