A Phase II Randomized Study of the Use of Artificial Intelligence Generated Contours in Ultrasound-based Prostate HDR Brachytherapy
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Brigham and Women's Hospital
- Enrollment
- 36
- Locations
- 1
- Primary Endpoint
- Clinically approved contour vs. Manual and AI assisted contours
Study Overview
Brief Summary
This study is investigating how AI can help doctors outline the prostate on an ultrasound image to make a custom radiation plan during a specialized type of radiation treatment for prostate cancer called brachytherapy.
Detailed Description
This is a Phase II prospective study evaluating the standard U-net, a deep learning AI algorithm for auto-contouring of the prostate during HDR prostate brachytherapy with the needles in place by new learners. Contouring will be done on TRUS. The study will be conducted with a randomized design. Each patient will be assigned to a new learner and then randomized to manual versus AI-assisted contouring. The randomization will be stratified by new learner type: resident versus fellow/new attending. The hypothesis is that AI-assisted learner contours will have improved Dice coefficients with respect to clinically approved contours compared with manual learner contours. All brachytherapy contours will undergo review by the treating radiation oncologist who is the experienced clinician for clinical approval prior to patient treatment. The experienced clinician will be blinded to the randomization.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Care Provider)
Masking Description
The experienced clinician will be blinded to the randomization of the contouring method by the new learner. The prostate contour generated by the new learner will then undergo review by the experienced clinician.
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •18 years of age and older
- •Deemed suitable candidates for whole gland HDR prostate brachytherapy under general anesthesia as a monotherapy, boost or salvage treatment.
Exclusion Criteria
- •Prior permanent seed LDR brachytherapy implant
- •Prior transurethral resection of the prostate (TURP)
- •Presence or insertion of a rectal spacer
- •Focal HDR brachytherapy treatment i.e. not whole prostate
Arms & Interventions
MANUALLY GENERATED CONTOURS IN ULTRASOUND-BASED PROSTATE HDR BRACHYTHERAP
Manual prostate contouring by a learner (resident or fellow/new attending) performing prostate HDR brachytherapy.
AI GENERATED CONTOURS IN ULTRASOUND-BASED PROSTATE HDR BRACHYTHERAPY
AI-assisted (U-net algorithm) prostate contouring by a learner (resident or fellow/new attending) performing prostate HDR brachytherapy.
Intervention: Artificial-intelligence (AI) (Other)
Outcomes
Primary Outcomes
Clinically approved contour vs. Manual and AI assisted contours
Time Frame: 1 day
Dice coefficient \[0: no match, 1: complete match\] between the final clinically approved brachytherapy prostate contours versus the manual and AI-assisted contours provided by the new learner.
Secondary Outcomes
- Contouring time(1 day)
- Impression of AI or manual contours by new learner(1 day)
- Impression of AI or manual contours by experienced clinician(1 day)
- Clinician contours vs. Trus images with and without needles(1 day)
Investigators
Martin T. King, MD, PhD
Radiation oncologist
Brigham and Women's Hospital