Bladder cancer
Conditions
Interventions
Index test:Oral administration of aminolevulinic acid hydrochloride granules combined with endoscopic PDD fluorescence imaging
Sponsors
Shanghai General Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 84 Years
Inclusion criteria
Inclusion criteria: Subjects must meet all of the following criteria to be enrolled in the study: 1. The subject voluntarily participates in the clinical study, understands and complies with all requirements of the study, has a full understanding of the study content, process and possible adverse reactions, and signs the Informed Consent Form (ICF). 2. At the time of signing the ICF, the subject is >=18 years old and < 85 years old, either male or female. 3. Subjects with suspected or confirmed non-muscle invasive bladder cancer (NMIBC), who are judged by the investigator to be suitable for transurethral resection of bladder tumor (TURBT). 4. Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 or 1. 5. All adverse reactions from previous anti-tumor therapy (including surgery) have resolved to the baseline level or recovered to <= Grade 1 as defined by the Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 (alopecia and peripheral neuropathy may be <=Grade 2). 6. Female subjects of childbearing potential are not pregnant or lactating from the screening period to 3 months after drug administration. 7. For women of childbearing potential (WOCBP) and male subjects whose sexual partners are WOCBP, they must voluntarily take effective contraceptive measures required by the protocol from the screening period to 3 months after drug administration, and have no plan to donate sperm or oocytes; WOCBP is defined as a female who has experienced menarche, is not surgically sterilized and has not undergone menopause.
Exclusion criteria
Exclusion criteria: Exclusion Criteria Subjects who meet any of the following exclusion criteria shall not be enrolled in this study: 1. Gross hematuria (defined in this study as severe hematuria that would interfere with endoscopic examination; if the investigator judges that the hematuria is mild and the interference with endoscopic examination can be eliminated by irrigation and/or electrocautery, the subject may not be excluded). 2. Use of intravesical immunotherapy or intravesical chemotherapy within 3 months prior to drug administration. 3. A history of allergic reactions to porphyrins and their analogs, or a history of allergies to 5-aminolevulinic acid (5-ALA) or drug components with similar structures; a history of porphyria or other photosensitive diseases. 4. Currently suffering from other active malignant tumors. 5. Active infection requiring hospitalization and/or intravenous anti-infective drug intervention within 2 weeks prior to drug administration, or unexplained fever occurring from the screening period to prior to drug administration with a significant increase in procalcitonin (if the investigator judges that the subject's fever is caused by bladder cancer, enrollment is allowed). 6. Patients with laboratory test results meeting any of the following conditions: (1)Blood routine: Absolute Neutrophil Count (ANC) = 1.5 × 10?/L; Platelets (PLT) = 100 × 10?/L; Hemoglobin (Hb) = 90 g/L (2) Liver function: Serum Total Bilirubin (TBIL) = 1.5 × Upper Limit of Normal (ULN); Aspartate Aminotransferase (AST) or Alanine Aminotransferase (ALT) = 2.5 × ULN; Serum Albumin (ALB) = 30 g/L (3) Renal function: Serum Creatinine (Scr) = 1.5 × ULN, or Creatinine Clearance (Ccr) = 50 mL/min (calculated according to the Cockcroft-Gault formula) 7. A history of severe cardiovascular and cerebrovascular diseases, including but not limited to: (1) History of severe heart disease, such as: history of Heart Failure (HF) = Grade 2 (NCI CTCAE v5.0), history of New York Heart Association (NYHA) cardiac function classification = Grade 2, myocardial infarction within 3 months, angina pectoris requiring drug treatment, etc.; (2) Severe arrhythmia judged by the investigator that may increase the safety risk of the subject; (3) Hypertension or hypotension poorly controlled by drugs, or clinically significant vascular diseases; 8. Severe comorbidities, including but not limited to patients with poorly controlled diabetes, end-stage liver cirrhosis, severe pulmonary fibrosis, active interstitial pneumonia, etc. 9. Patients with active chronic inflammatory bowel disease, a history of intestinal obstruction, a history of gastrointestinal perforation, or a history of other gastrointestinal diseases that affect drug administration or absorption. 10. Severe arterial/venous thrombosis events occurring within 1 year prior to signing the ICF, such as cerebrovascular accident (including transient ischemic attack), deep vein thrombosis, pulmonary embolism. 11. Patients with severe mental disorders. 12. Participation in clinical trials of other drugs or medical devices within 3 months prior to signing the ICF and receiving investigational drugs or using medical devices. 13. Other conditions judged by the investigator to be unsuitable for participation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Comparison of NMIBC detection rates between 5-ALA hydrochloride granules with PDD fluorescence endoscopy and conventional white-light endoscopy; | — |
Secondary
| Measure | Time frame |
|---|---|
| Comparison of detection rates of bladder cancer CIS lesions between 5-ALA hydrochloride granules with PDD fluorescence endoscopy and conventional white-light endoscopy.;Comparison of false-positive rates between PDD fluorescence endoscopy with 5-ALA hydrochloride granules and conventional white-light endoscopy for bladder cancer detection.;To evaluate the safety of orally administered 5-aminolevulinic acid hydrochloride granules combined with endoscopic PDD fluorescence system.;To evaluate the pharmacokinetic characteristics of orally administered 5?aminolevulinic acid hydrochloride granules.;To subjectively evaluate the fluorescence imaging quality of the endoscopic PDD fluorescence system.;To evaluate the overall device performance of the endoscopic PDD fluorescence system.; | — |
Countries
China
Contacts
Public ContactXu Chuanliang
Shanghai General Hospital (Shanghai First People’s Hospital Affiliated to Shanghai Jiao Tong University School of Medicine)
Outcome results
None listed