A Phase II Study on Photodynamic Diagnosis of Urological Cancer in the Upper Urinary Tract Using Fluorescence Endoscopy With Cystoscopy and Ureteroscopy With 5-ALA
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Detection of tumor fluorescence using 5-ALA under blue light
研究概览
简要总结
This study is evaluating whether a medication called 5-aminolevulinic acid (5-ALA), approved by the FDA for use in brain surgery, can help improve the visibility of upper tract urothelial tumors during surgery. Patients undergoing ureteroscopic tumor resection will receive 5-ALA prior to surgery, and surgeons will use special blue light to help identify abnormal tissue that might not be seen under standard white light. The goal is to assess whether this technique can enhance tumor detection and removal.
详细描述
This is a prospective, single-arm feasibility study investigating the use of 5-aminolevulinic acid (5-ALA, Gleolan) to enhance intraoperative tumor visualization in patients undergoing ureteroscopic resection for suspected upper tract urothelial carcinoma (UTUC). 5-ALA is an FDA-approved oral agent used in glioma surgery to promote fluorescence of malignant tissue under blue light. This study will evaluate whether similar visualization can be achieved in the upper urinary tract to aid in the identification and resection of UTUC. Up to 10 participants will be enrolled. Safety, technical feasibility, and tumor detection outcomes will be measured.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 18 or older undergoing diagnostic or therapeutic ureteroscopy for a known or suspected upper tract urothelial tumor
- •Able to provide informed consent
- •Able to comply with study requirements
排除标准
- •Known porphyria or hypersensitivity to porphyrins
- •Pregnant or breastfeeding women
- •AST or ALT > 2x upper limit of normal within 30 days prior to surgery
- •Participation in another investigational study within 30 days
- •Known allergy or contraindication to 5-ALA or its components
研究组 & 干预措施
5-ALA Fluorescence Imaging
Participants will receive a single oral dose of 5-aminolevulinic acid (5-ALA, Gleolan) 2-4 hours prior to ureteroscopic tumor resection. Blue light endoscopy will be used intraoperatively to assess tumor fluorescence and aid in visualization and resection.
干预措施: 5-Aminolevulinic acid Hydrochloride (Gliolan®) (Drug)
结局指标
主要结局
Detection of tumor fluorescence using 5-ALA under blue light
时间窗: Day of Surgery
Surgeons will assess whether upper tract urothelial tumors exhibit visible fluorescence under blue light following oral administration of 5-ALA (20 mg/kg). Presence or absence of fluorescence will be recorded for each lesion during ureteroscopic resection.
次要结局
- Incidence and severity of adverse events following 5-ALA administration(Up to 30 days post-procedure)
- Presence of residual tumor at follow-up ureteroscopy(Up to 3 months post-procedure)
研究者
Johar Raza
Urologic Oncologist, Henry Ford Health
Henry Ford Health System