Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
NCT Number: NCT06964412
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.
This study is active but is not currently recruiting participants.
Notify Me18 year and older
Male
Interventional
Not applicable
Boston, Massachusetts, 02115, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Utilizing the addition of artificial intelligence during prostate contouring.
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.
Time frame: 1 day
Contouring time-to-completion needed to generate and edit manual vs AI-assisted contours for a new learner.
Time frame: 1 day
Subjective impressions/perception of AI or manual contours by the new learner based on survey responses.
Time frame: 1 day
Subjective impressions/perception of AI or manual contours by the experienced clinician based on survey responses.
Time frame: 1 day
Dice coefficients of expert clinician contours between TRUS images with implanted needles and TRUS images after removal of bottom needle rows.
Brigham and Women's Hospital
Other
A Phase II Randomized Study of the Use of Artificial Intelligence Generated Contours in Ultrasound-based Prostate HDR Brachytherapy
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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