jRCT2061210055已完成不适用
A Phase III Study for Modification of Photodynamic Diagnosis of SPP-005 in Patients with Non-muscle Invasive Bladder Cancer (NMIBC) during Transurethral Resection of Bladder Tumor (TURBT)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 106
- 主要终点
- sensitivity
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Single Arm Study
- 干预模型
- Single Assignment
- 主要目的
- Diagnostic Purpose
- 盲法
- Open(masking Not Used)
入排标准
- 年龄范围
- 20age old over 至 85age old not（—）
- 性别
- All
入选标准
- •Patients who are eligible for TURBT
- •Patients who understand the informed consent document and can provide a written consent of their own free will
- •Patients who are between 20 and 85 years old (at the time of signing the informed consent document)
- •Patients with an ECOG Performance Status (ECOG PS) of 0 to 1 as determined at the time of enrollment
- •Patients whose clinical laboratory values meet the following criteria (laboratory tests within 28 days prior to IMP administration)
- •[Renal function]
- •Serum creatinine: Less than 1.5 times the upper limit of the institutional standard
- •[Hepatic function]
- •AST (GOT): Less than 1.5 times the upper limit of the institutional standard
- •ALT (GPT): Less than 1.5 times the upper limit of the institutional standard
- •Serum bilirubin: Less than 1.5 times the upper limit of the institutional standard
- •Platelet count:100,000/mm3 or more
- •Patients who are able to comply with the requirements of the study protocol, including the schedule of visit days
- •Patients suspected of having NMIBC, whether primary or recurrent, and in case of recurrence parents, at least 90 days have passed since the last day of the bladder cancer treatment.
排除标准
- •Patients with a history of or complications from any of the following
- •Myocardial infarction
- •Congestive heart failure
- •Angina pectoris requiring treatment
- •Arrhythmia requiring treatment
- •Patients with serious complications (interstitial pneumonia, pulmonary fibrosis, poorly controlled hypertension, diabetes mellitus, etc.)
- •Patients with serious infectious diseases (including active tuberculosis)
- •Patients with active multiple cancers
- •Patients with systolic blood pressure of 100 mmHg or less, or diastolic blood pressure of 60 mmHg or less on the screening examination
- •Patients with a history of hypotension during previous TURBT
- •Female patients who are pregnant, lactating, or may be pregnant
- •Patients who do not intend to use contraception*
- •Patients with hypersensitivity or a history of hypersensitivity to porphyrin analogs.
- •Patients who have received any investigational medical product (including study drugs in post-marketing clinical studies) within 90 days prior to the start of screening examination
- •Patients who are scheduled to participate in clinical trials, etc. during the clinical trial period
- •Other patients who are judged to be inappropriate by the principal or sub investigators.
- •Examples of contraception methods: condom, intrauterine device (IUD) and oral contraceptives (if a female participant use an oral contraceptive, a barrier method must be used concurrently).
结局指标
主要结局
sensitivity
Proportion of biopsy samples diagnosed as positive under BL out of the biopsy samples confirmed pathologically positive those collected during TURBT when SPP-005 administrates 4-8 hours before inserting the cystoscope
次要结局
未报告次要终点
研究者
相似试验
进行中（未招募）
3 期
A Phase III Study for Modification of Photodynamic Diagnosis of SPP-005JPRN-jRCT2061210055Yamauchi Mitsugu106
招募中
2 期
The effect of of photodynamic therapy with methylene blue on the treatment of cutaneous leishmaniosisCutaneous leishmaniasis.Cutaneous leishmaniasisB55.1IRCT20200803048289N1Mashhad University of Medical Sciences8
已完成
不适用
ong-term results of the modified photodynamic therapy (PDT) procedure for exudative age-related macular degeneration (AMD) patients with difficulties in PDTExudative age-related macular degenerationJPRN-UMIN000010862Kansai medical university takii hospital10
进行中（未招募）
不适用
Multi-institutional phase II study of photodynamic therapy using ME2906 and PNL6405SCT for patients with malignant spinal cord tumor.jRCT202122004020
招募中
2 期
Multi-institutional phase II study of photodynamic therapy using ME2906 and PNL6405SCT for patients with malignant spinal cord tumor.spinal cord malignant tumorMalignancyD013120JPRN-jRCT2021220040Endo Toshiki20