PHOTOdynamic versus white light-guided treatment of non-muscle invasive bladder cancer: randomised trial of clinical and cost-effectiveness

ewcastle upon Tyne Hospitals NHS Foundation Trust (UK)0 个研究点目标入组 538 人开始时间: 2014年7月25日最近更新: 2023年5月8日

适应症

试验速览

2019 Protocol article in https://pubmed.ncbi.nlm.nih.gov/31481549/ protocol (added 05/10/2020) 2022 Results article in https://doi.org/10.1056/EVIDoa2200092 (added 27/09/2022) 2022 Results article in https://pubmed.ncbi.nlm.nih.gov/36300825/ (added 28/10/2022)

•1. Adult men and women aged = 16 years
•2. First suspected diagnosis of bladder cancer
•3. Visual/ultrasound/CT diagnosis of intermediate/high risk NMIBC
•3.1. White light visual appearances of intermediate or high risk disease (=> 3cm, two or more tumours, or flat velvety erythematous changes alerting a clinical suspicion of CIS).
•3.2. Suspicion of papillary bladder tumour > 3cm based on ultrasound or computerized tomography (CT) scanning (without hydronephrosis)
•4. Written informed consent for participation prior to any study specific procedures
•5. Willing to comply with lifestyle guidelines

•1. Visual evidence of low risk NMIBC (solitary tumour < 3cm)
•2. Visual evidence of MIBC on preliminary cystoscopy, i.e. nonpapillary or sessile mass (attached directly by its base without a stalk)
•3. Imaging evidence of MIBC CT/USS (this includes the presence of hydronephrosis, which may be present despite clear imaging of MIBC in the bladder)
•4. Upper tract (kidney or ureteric) tumours on imaging
•5. Any other malignancy in the past 2 years (except: nonmelanomatous skin cancer cured by excision, adequately treated carcinoma in situ of the cervix, DCIS/LCIS of the breast or prostate cancer in patients who have a life expectancy of >5 years upon trial entry)
•6. Evidence of metastases
•7. Porphyria or known hypersensitivity to porphyrins
•8. Known pregnancy (based on history and without formal testing, in keeping with day-to-day NHS practice of PDD use)
•9. Any other conditions that in the Principal Investigator?s opinion would contraindicate protocol treatment
•10. Unable to provide informed consent
•11. Unable or unwilling to complete follow up schedule (including questionnaires)

发起方

ewcastle upon Tyne Hospitals NHS Foundation Trust (UK)