Testing a WearabLE Artificial Intelligence-POwered Device For OPtimal DAily RaDiation Therapy Using Image Guidance

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.

Inclusion criteria

• Age ≥18 years.
• Ability to voluntarily drink water and fill an intact bladder preparing for radiation treatment.
• Patients (not healthy volunteers) can have any pelvic malignancy (e.g., rectal cancer, prostate cancer, bladder cancer, cervical cancer, anal cancer, endometrial cancer, sarcoma, bone metastatic lesions) being treated with radiation therapy.
• Ability to understand a written informed consent document, and the willingness to sign it.

Exclusion criteria

• Prior allergic reaction to ultrasound gel, which is composed of water and propylene glycol.
• Inability to place device on skin (excessive hair or body habitus that is prohibitive).