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

NCT06820385 | Recruiting DMC FDA Device

• 1 other identifier: PRO00054270
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pelvic Malignancies

Keywords

Device feasibility study

Outcome Measures

Primary Outcomes (1)

• 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%.

  Up to 2 months

Study Arms (2)

Healthy volunteers

EXPERIMENTAL

Five healthy volunteers will be enrolled in this study.

Device: Fullyet Device and MRI Scans

Cancer patients

EXPERIMENTAL

Ten cancer patients will be enrolled into this study.

Device: Fullyet Device and CT Scans

Interventions

Fullyet Device and CT Scans DEVICE

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.

Cancer patients

Fullyet Device and MRI Scans DEVICE

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.

Healthy volunteers

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Medical College of Wisconsin: lead

Study Sites (1)

Froedtert & the Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

RECRUITING

MeSH Terms

Interventions

Tomography, X-Ray Computed; Magnetic Resonance Imaging

Intervention Hierarchy (Ancestors)

Image Interpretation, Computer-Assisted; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Radiographic Image Enhancement; Image Enhancement; Photography; Radiography; Tomography, X-Ray; Tomography

Study Officials

• Kevin Rogacki, MD

  Medical College of Wisconsin

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Medical College of Wisconsin Cancer Center Clinical Trials Office

CONTACT

866-680-0505; cccto@mcw.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: This study will enroll cancer patients who receive CT scans and healthy volunteers who receive MRI scans.

Study Record Dates

• First Submitted: February 5, 2025
• First Posted: February 11, 2025
• Study Start: May 2, 2025
• Primary Completion (Estimated): October 30, 2026
• Study Completion (Estimated): October 30, 2026
• Last Updated: September 15, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)