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

N/ARecruitingNCT06820385

Medical College of Wisconsin15 enrolled

Overview

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 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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

SCREENING

Masking

NONE

Enrollment

Conditions

Pelvic Malignancies

Interventions

Fullyet Device and CT ScansDEVICE

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.

Fullyet Device and MRI ScansDEVICE

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.

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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. Inability to place device on skin (excessive hair or body habitus that is prohibitive).

Locations (1)

Froedtert & the Medical College of Wisconsin

Milwaukee, Wisconsin, United States

RECRUITING

Outcomes

Primary Outcomes

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%.

Time frame: Up to 2 months

Central Contacts

Medical College of Wisconsin Cancer Center Clinical Trials Office

CONTACT

866-680-0505 cccto@mcw.edu

Data from ClinicalTrials.gov

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