Medical College of Wisconsin
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.
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 radiatio…
Inclusion Criteria: 1. Age ≥18 years. 2. Ability to voluntarily drink water and fill an intact bladder preparing for radiation treatment. 3. 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. 4. Ability to understand a written informed consent document, and the willingness to sign it. Exclusion Criteria: 1. Prior allergic reaction to ultrasound gel, which is composed of water and propylene glycol. 2. In…
Cancer patients will wear the Fullyet Device. Real-time data will go to the patient and radiation therapy team. When the Fullyet Device indicates that the bladder is at optimal size, the radiation oncology team will get the patient. The patient will then have a CT scan.
Healthy volunteers will first have an MRI scan. Then, they will wear the Fullyet Device. They will have up to two more MRIs to confirm bladder volume.
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