Pilot Study: Assessing Near Infrared Fluorescence Imaging Medical Technology for the Detection of Bladder Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Minimal Dwell Time
研究概览
简要总结
The primary outcome of this study is to determine the minimal dwell time needed for adequate detection of hexaminolevinulate HCL avid tumors using protoporphyrin IX (PpIX) near infrared fluorescence (NIRF).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 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
- •Diagnosis of bladder mass on office cystoscopy suspicious for malignancy, either newly diagnosed or a recurrent tumor.
- •Planned transurethral resection of bladder tumor in the operating room.
- •Ability to give informed consent.
- •Willing to spend time for the study
- •Men or women (age 18 or older)
- •Any racial or ethnic origin
排除标准
- •Pregnancy
- •Nursing mother
- •Diagnosis of porphyria
- •Gross hematuria
- •BCG immunotherapy or intravesical chemotherapy within the past 90 days
- •Known hypersensitivity to hexaminolevulinate or any derivative of aminolevulinic acid
研究组 & 干预措施
Hexaminolevinulate HCL with Near Infrared Fluorescence (NIRF)
During the transurethral resection of the bladder procedure, the bladder will initially be examined in a systematic meridian fashion. Suspicious tumors identified by white light only, NIRF only, and both will be identified. If intense fluorescence is observed in the initial patient(s) at 10 min, dwell duration will be reduced to 5 min for the next patient(s); if abundant fluorescence is detected there as well, dwell duration will be shortened again to 2.5 min. At least three patients will be studied at each duration to document intense fluorescence before proceeding to shorter instillation durations in subsequent patients.
干预措施: Hexaminolevulinate HCL (Drug)
Hexaminolevinulate HCL with Near Infrared Fluorescence (NIRF)
During the transurethral resection of the bladder procedure, the bladder will initially be examined in a systematic meridian fashion. Suspicious tumors identified by white light only, NIRF only, and both will be identified. If intense fluorescence is observed in the initial patient(s) at 10 min, dwell duration will be reduced to 5 min for the next patient(s); if abundant fluorescence is detected there as well, dwell duration will be shortened again to 2.5 min. At least three patients will be studied at each duration to document intense fluorescence before proceeding to shorter instillation durations in subsequent patients.
干预措施: Near Infrared Fluorescence (NIRF) (Device)
结局指标
主要结局
Minimal Dwell Time
时间窗: Day 1
The minimum time needed to observe the tumors during transurethral resection of bladder tumor (TURBT).
次要结局
未报告次要终点
研究者
Edward Messing
Principal Investigator
University of Rochester