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.
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.
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).
Parallel
Fullyet Device and CT Scans
DeviceCancer 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.
Fullyet Device and MRI Scans
DeviceHealthy 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.
The number of events showing feasibility
The feasibility of acquiring and assessing relative bladder volume and morphology will be measured using the Fullyet wearable imaging device and compared to CT (for patients) or MRI (for healthy volunteers). Specifically, feasibility will be the number of events showing successful data acquisition. A successful data acquisition event refers to the device's ability to approximate bladder size to that measured on the daily cone beam CT (for patients) or MRI (for health volunteers) to approximately ±30%.
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