The Impact of PDD During TURB for NMIBC

Официальное название

The Impact of PDD During TURB for NMIBC: a Prospective Randomized Controlled Trial

Обзор

The goal of this clinical trial is to learn if photodynamic diagnosis (PDD) performed using violet light after intra-vesical instillation of hexaminolaevulinic acid (Hexvix 85mg/50ml) is more sensitive than the standard white light tecnique in detection of malignant bladder tumour. Patients will be randomised to: * Transurethral resection of the bladder (TURB) with a standard white light tecnique * TURB with the PDD tecnique using the study drug Hexvix

Подробное описание

Non-muscle invasive pT1 high-grade (HG) bladder cancer (NIMBC) represents a challenge for the urologists due to its aggressive behavior, with a marked tendency to recur after transurethral resection of the bladder (TURB) and even progress to muscle-invasive disease. To limit the risk of upstaging and to provide more clinical information indispensable for the decision-making process, international guidelines strongly recommend a re-TURB to be performed within 2-6 weeks from the first resection in all pT1HG tumors. However, not all the published literature agrees on the value of re-TURB wich is also an invasive and morbid procedure, requires a general or locoregional anesthesia and, like all surgical procedure, it is not free of risks and complications. There is, therefore, an unmet need for improving the quality and completeness of TURB which may have an impact on the necessity of Re-TURB. It has been confirmed that fluorescence-guided biopsy and resection (photodynamic diagnosis-PDD) are more sensitive than conventional procedures for the detection of malignant tumours, particularly for CIS. PDD is performed using violet light after intra-vesical instillation of hexaminolaevulinic acid (Hexvix 85mg/50ml).To date, no randomized controlled trials (RCTs) have been conducted aiming to compare the completeness of TURB with PDD compared to TURB with standard white light (WL).

Вмешательства

• Процедура Transurethral resection of the bladder performed with PDD tecnique and Hexvix
  For the execution of PDD cystoscopy in blue light, it is necessary to use the study drug (Hexvix) which, after intravesical instillation, causes an accumulation of porphyrins in the lesions of the bladder wall at the intracellular level. The intracellular porphyrins are photoactive fluorescent compounds that emit red light when excited with blue light. Consequently, the preneoplastic and neoplastic lesions will emit a red luminescence against a blue background, allowing for better visualisation

Первичные конечные точки

• Residual disease and/or upstaging [Срок оценки: 6 to 8 weeks from the intervention]

Вторичные конечные точки (5)

• Number of Participants diagnosed with malignant lesions [Срок оценки: 6 to 8 weeks from the intervention]
• The European organization for reasearch and treatment of cancer quality of life questionnaire for patients with non-muscle invasive bladder cancern [Срок оценки: from date of randomization until 20 weeks from randomization]
• EQ-5D-5L [Срок оценки: from date of randomization until 20 weeks from randomization]
• EQ VAS [Срок оценки: from date of randomization until 20 weeks from randomization]
• Adverse events [Срок оценки: from date of randomization until 20 weeks from randomization]

Критерии участия

Критерии включения

• Voluntarily signed informed consent per Good Clinical Practice and national regulations
• Age ≥ 18 years
• Patient planned for TURB for >1,5 cm suspected (with either abdomen ultrasound or flexible cystoscopy) primary bladder cancer. The cut-off of 1,5cm has been chosen to maximize the probability of enrolling high-risk patients and, consequently, to maximize the probability of performing the re-TURB.

Критерии исключения

• Patients with history of recurrent NMIBC
• Patients with visible incomplete resection during primary TURB
• Patients with metastatic disease or with a preoperative CT scan highly suspected for MIBC

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Диагностика

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06548438 · CDS01FS

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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