TraceIT TM Hydrogel Tissue Marker for Patients Receiving Definitive Chemoradiation for Bladder Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Changes in Interfraction Motion of the Marker Measured by Cone Beam Computed Tomography (CT) and x/y/z Coordinates
研究概览
简要总结
This pilot clinical trial studies how well TracelT hydrogel works in localizing bladder tumors in patients undergoing radiation therapy for bladder cancer. TracelT hydrogel marks the location of a bladder tumor and makes it more visible during imaging tests. Using TracelT hydrogel tissue marker may help doctors learn more about tumor location and altering radiation dosage for bladder cancer.
详细描述
PRIMARY OBJECTIVES:
I. To utilize the TraceIT hydrogel tissue marker in localizing bladder tumors during transurethral resection of bladder tumors (TURBT).
II. To improve identification of gross tumor or tumor bed location in patients receiving chemoradiation treatment for bladder cancers.
SECONDARY OBJECTIVES:
I. To report adverse events surrounding the placement of the TraceIT tissue marker.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- 否
入选标准
- •Histologically confirmed malignancy of the bladder
- •No prior cystectomy
- •Treatment plan for bladder must include at least 4 weeks of daily radiation treatment (most patients will receive chemotherapy concurrent with radiation, but this is not required for trial enrollment)
- •Patient must undergo TraceIT hydrogel placement within 8 weeks prior to starting radiation therapy for bladder cancer
- •Participants must have a complete history and physical examination within 60 days of study entry
- •Participants must be able to provide informed consent for treatment and trial participation
- •No restrictions on prior treatment to be eligible
排除标准
- •Prior cystectomy
- •Unable to have TraceIT hydrogel placement < 8 weeks prior to beginning radiation treatment
- •Treatment for metastatic bladder cancer
结局指标
主要结局
Changes in Interfraction Motion of the Marker Measured by Cone Beam Computed Tomography (CT) and x/y/z Coordinates
时间窗: Baseline up to 8 weeks
Daily changes will be compared across the patient group as well as within each subjects' treatment course.
Changes in Tumor Bed Size and Shape as Delineated by the Hydrogel and Measured by Cone Beam CT and x/y/z Coordinates
时间窗: Baseline up to 8 weeks
Daily changes will be compared across the patient group as well as within each subjects' treatment course. These changes will be tracked during the entire radiation course (typically 4-8 weeks), yielded a distribution of x/y/z positions for each patient.
次要结局
- Daily Dose to the Planning Tumor Volume (PTV) Based on Hydrogel Location(Up to 8 weeks)
- Smallest Setup Margin Required for Consistent Coverage of the Gross Tumor Volume (GTV)(Up to 8 weeks)
- Number of Participants With Adverse Events Caused by Hydrogel(Up to 1 year)
- Daily Dose of Radiation to the PTV as Based on Alignment to the Hydrogel Location Versus Alignment to Whole Bladder Location Versus Alignment to Bony Antonym(Up to 8 weeks)
研究者
Jing Zeng
Associate Professor, Department of Radiation Oncology
University of Washington