NCT06727032

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
12

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 5, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 10, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

January 24, 2025

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2025

Completed
Last Updated

August 3, 2025

Status Verified

August 1, 2025

Enrollment Period

7 months

First QC Date

December 5, 2024

Last Update Submit

August 1, 2025

Conditions

Brain Metastases

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (2)

  • Reading time

    3 months

  • Inter-reader agreement

    3 months

Interventions

Brain Metastasis AIDEVICE

There will be no intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Brain Metastasis

You may qualify if:

  • subjects older than 18 years with a known or possible primary extracranial cancer who undergo MRI for diagnosis, treatment planning or follow-up of brain metastases.

You may not qualify if:

  • subjects with primary intracranial tumor(s), with more than 10 brain metastases, with meningeal metastases, with radiation necrosis, or post brain surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Netherlands Cancer Institute

Amsterdam, Netherlands

Location

MeSH Terms

Conditions

Brain Neoplasms

Condition Hierarchy (Ancestors)

Central Nervous System NeoplasmsNervous System NeoplasmsNeoplasms by SiteNeoplasmsBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 5, 2024

First Posted

December 10, 2024

Study Start

January 24, 2025

Primary Completion

September 1, 2025

Study Completion

October 1, 2025

Last Updated

August 3, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations

NL(1)