Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06546592
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-25
Brief Title:
Locally Optimised Contouring With AI Technology for Radiotherapy
Sponsor:
None
Organization:
None
Study Overview
Official Title:
LOCATOR - Locally Optimised Contouring With AI Technology for Radiotherapy
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
LOCATOR
Brief Summary:
LOCATOR is a phase II randomised clinical trial that is looking at the process of contouring in radiation treatment This study looks at whether contouring aided by artificial intelligence AI is comparable in quality to that of contouring done completely manually by a radiation oncologist We are also looking at whether AI assisted contouring saves radiation oncologists time when compared to fully manual contouring
LOCATOR uses the LOCATOR software which is an in-house software developed locally and trained on local data
LOCATOR uses the LOCATOR software which is an in-house software developed locally and trained on local data
Detailed Description:
LOCATOR is a two-stage phase II non-inferiority randomised controlled trial looking at comparing AI assisted contours with in-house LOCATOR software against fully manual contouring The primary endpoints in stage 1 of the study n250 is to show time savings with AI assisted contouring compared to manual contouring Stage 2 of the study total n520 will show non inferiority in grade of AI assisted contouring when compared to fully manual contouring with a poor contour score 2 as per the MD Anderson Contouring Grade Scale ii Secondary geometric assessments of contour accuracy dosimetric differences based on contours performance geometric when compared to commercially available tools as well as economic cost-benefit analysis if in-house AI contouring tools
The study will randomise patients 41 to the intervention arm of LOCATOR assisted contours to manual contours An initial AI contouring model for each tumor type will be trained on contours from 50-100 previous patients using a nnUNetV2 framework The model will then be iteratively updated every 50-100 patients Quality assurance will include a blinded check of contours by a second radiation oncologist
The study will randomise patients 41 to the intervention arm of LOCATOR assisted contours to manual contours An initial AI contouring model for each tumor type will be trained on contours from 50-100 previous patients using a nnUNetV2 framework The model will then be iteratively updated every 50-100 patients Quality assurance will include a blinded check of contours by a second radiation oncologist
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None