Testing a WearabLE Artificial Intelligence-POwered Device For OPtimal DAily RaDiation Therapy Using Image Guidance
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- The number of events showing feasibility
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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).
研究组 & 干预措施
Healthy volunteers
Five healthy volunteers will be enrolled in this study.
干预措施: Fullyet Device and MRI Scans (Device)
Cancer patients
Ten cancer patients will be enrolled into this study.
干预措施: Fullyet Device and CT Scans (Device)
结局指标
主要结局
The number of events showing feasibility
时间窗: 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%.
次要结局
未报告次要终点
研究者
Kevin R. Rogacki, MD
Assistant Professor
Medical College of Wisconsin