Testing a WearabLE Artificial Intelligence-POwered Device For OPtimal DAily RaDiation Therapy Using Image Guidance
Start Date
5/2/2025
Completion Date
10/30/2026
Summary
This is a device feasibility study to determine the feasibility of automatically predicting time to treatment readiness using a wearable imaging device (Fullyet) in both healthy volunteers and patients with pelvic malignancies undergoing radiation therapy.
Detailed Description
The purpose of this study is to test an experimental wearable, ultrasound-based device to measure the fullness of the bladder. In order to protect organs at risk of damage, treatment timing with pelvic radiation depends on a full bladder each day. Right now, people drink water and guess when their bladders are full. Each day, CT scans are taken immediately before radiation treatment to look at the size and shape of the bladder and rectum. Up to 50% of patients are not ready for treatment. They must return to the waiting area to fill their bladder. Over a typical course of fractionated radiation therapy, patients require five to six extra scans to make sure that the bladder is ready for treatment. Delays can cause stress and anxiety for the patient, as well as the administration of unnecessary CT scans resulting in higher radiation exposure.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
Fullyet Device and CT Scans
Fullyet Device and MRI Scans
Conditions
Locations
Froedtert & the Medical College of Wisconsin
Milwaukee, Wisconsin 53226
United States