Ignite Creation Date:
2025-12-24 @ 9:26 PM
Ignite Modification Date:
2025-12-30 @ 11:15 PM
Study NCT ID:
NCT06727032
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-08-03
First Post:
2024-12-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Automated Detection of Brain Metastases on MRI
Sponsor:
Robovision BV
Organization:
Study Overview
Official Title:
Validation of an AI Software for Detection of Brain Metastases on MRI: AIDED Versus UNAIDED Performance
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2025-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BrainMets AI
Brief Summary:
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.
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.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| IRBd20-090 | OTHER | IRB NKI-AVL | View |