A Prospective, Comparative Within Patient Controlled, Multi-center Study of Hexvix Blue Light Cystoscopy and White Light Cystoscopy in the Detection of Bladder Cancer
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 158
- 试验地点
- 7
- 主要终点
- Number of Patients With Histology-confirmed Lesions (Ta, T1, or CIS) Who Have at Least One Such Lesion Found by Hexvix Blue Light Cystoscopy But Not by White Light Cystoscopy.
研究概览
简要总结
A study to compare Hexvix Blue light cstoscopy with standard White light cystoscopy in the detection of bladder cancer.
详细描述
A phase III, prospective, within patient controlled, multi-center study to compare Blue light cystoscopy with Hexvix and standard White light cystoscopy in the detection of bladder cancer, to evaluate the efficacy and safety of Hexvix Blue light cystoscopy in Chinese population.
Patients with suspicious or confirmed bladder cancer will participate in the trial and undergo Blue light cystoscopy with Hexvix in addition to the standard White light cystoscopy. Specific clinical questions will be asked:
- What is the proportion of patients who have at least one specific kind of tumor found by Blue light cystoscopy with Hexvix but not by White light cystoscopy?
- What is the proportion of patients who have at least one specific kind of lesion found by Blue light cystoscopy with Hexvix but not by White light cystoscopy?
- What is the proportion of false positive lesions detected with Hexvix Blue light cystoscopy and White light cystoscopy?
- What is the proportion of patients with Adverse Events (AE) during the study?
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Volunteer to participate in clinical study; thoroughly informed, signed and dated the informed consent form; willing to follow and have the ability to complete all trial procedures.
- •Suspicious or confirmed patients with bladder cancer.
- •Age 18 or older.
排除标准
- •Gross haematuria. (Note: Gross haematuria is defined as a heavy bladder bleed resulting in marked amounts of blood in the urine, which may visually limit cystoscopy. Where the haematuria is light, the patient should not be excluded, if in the investigator's opinion, rinsing and/or electro-cautery during cystoscopy will alleviate the possible interference with cystoscopy).
- •Patients who have received BCG immunotherapy or intravesical chemotherapy within the past 6 weeks prior to the procedure.
- •Known allergy to hexaminolevulinate hydrochloride or a similar compound.
- •Pregnancy or breast-feeding or women who plan to become pregnant during the trial, and men or women who are unwilling to take barrier contraceptives from 2 weeks before application of investigational medication to 28 days after application of investigational medication (Note: All women of child-bearing potential must document a negative urine pregnancy test before study inclusion and use adequate contraception during the study.
- •Participation in other clinical studies with investigational drugs either concurrently or within the last 30 days.
- •Patient is the investigator or any sub investigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the protocol.
- •Patients that the investigator assessed unsuitable to the study.
- •Subjects with contraindications to white light cystoscopy.
研究组 & 干预措施
Hexvix Blue light cystoscopy
In this study, enrolled patients will undergo standard White light cystoscopy and Blue light cystoscopy following Hexvix administration. Lesions detected during the cystoscopies will be resected or biopsied.
干预措施: Hexaminolevulinate Hydrochloride (Drug)
Hexvix Blue light cystoscopy
In this study, enrolled patients will undergo standard White light cystoscopy and Blue light cystoscopy following Hexvix administration. Lesions detected during the cystoscopies will be resected or biopsied.
干预措施: Richard Wolf Photodynamic Diagnostic Equipment (PDD) system (Device)
结局指标
主要结局
Number of Patients With Histology-confirmed Lesions (Ta, T1, or CIS) Who Have at Least One Such Lesion Found by Hexvix Blue Light Cystoscopy But Not by White Light Cystoscopy.
时间窗: 1 day (At time of cystoscopy examination)
In the subsection of patients with histology-confirmed lesions (Ta, T1, or CIS) , the number of patients who have at least one such lesion found by Hexvix blue light cystoscopy but not by white light cystoscopy is measured.
次要结局
- Number of Subjects With at Least One Additional CIS Lesion Detected With Hexvix Blue Light Cystoscopy But Not With White Light Cystoscopy.(1 day (At time of cystoscopy examination))
- Number of Lesions Detected With Hexvix Blue Light Cystoscopy and White Light Cystoscopy for Following Lesion Types (Papillary Urothelial Neoplasm of Low Malignant Potential (PUNLMP), Carcinoma in Situ (CIS), Ta, T1, T2-T4).(1 day (At time of cystoscopy examination))
- The Proportion of False Positive Lesions Detected With Hexvix Blue Light Cystoscopy and White Light Cystoscopy.(1 day (At time of cystoscopy examination))