Pelvic Malignancies
Conditions
Keywords
Device feasibility study
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.
Detailed description
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.
Interventions
DEVICEFullyet Device and CT Scans
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.
DEVICEFullyet Device and MRI Scans
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.
Sponsors
Medical College of Wisconsin
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
NONE
Intervention model description
This study will enroll cancer patients who receive CT scans and healthy volunteers who receive MRI scans.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The number of events showing feasibility | Up to 2 months | 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%. |
Countries
United States
Contacts
CONTACTMedical College of Wisconsin Cancer Center Clinical Trials Office
PRINCIPAL_INVESTIGATORKevin Rogacki, MD
Medical College of Wisconsin
Outcome results
None listed