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

Conditions

• Pelvic Malignancies

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Accepted

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.
• 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.

Study Details

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.

Key Dates

First listed

Feb 11, 2025

Start date

May 2, 2025

Status verified

Sep 2026

Primary completion

Oct 30, 2026

Completion

Oct 30, 2026

Study Design

Enrollment

15 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SCREENING

Arms

• Experimental: Healthy volunteers
  Five healthy volunteers will be enrolled in this study.
• Experimental: Cancer patients
  Ten cancer patients will be enrolled into this study.

Primary Outcome Measure

The number of events showing feasibility [ Time Frame: Up to 2 months ]

Central Contacts

• Medical College of Wisconsin Cancer Center Clinical Trials Office
  866-680-0505
  [email protected]

Locations (1)

Find similar trials in Milwaukee, WI

Related Studies

• Utero-ovarian Transposition in Patients With Pelvic Malignancies Undergoing Whole Pelvic Radiotherapy
  Recruiting · University of South Florida · Tampa, Florida