A Phase II Randomized Study of the Use of Artificial Intelligence Generated Contours in Ultrasound-based Prostate HDR Brachytherapy
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- Clinically approved contour vs. Manual and AI assisted contours
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Care Provider)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Artificial-intelligence (AI) (Other)
结局指标
主要结局
Clinically approved contour vs. Manual and AI assisted contours
时间窗: 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.
次要结局
- 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)
研究者
Martin T. King, MD, PhD
Radiation oncologist
Brigham and Women's Hospital