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NCT Number: NCT06548438

The Impact of PDD During TURB for NMIBC

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

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Key information

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Treatment and study plan

Transurethral resection of the bladder performed with PDD tecnique and Hexvix

Procedure

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 and subsequent resection.

Primary outcomes

  1. Residual disease and/or upstaging

    Time frame: 6 to 8 weeks from the intervention

    Compare the completeness of TURB with PDD vs TURB with WL in terms of proportion of patients with residual disease and/or upstaging at re-TURB

Secondary outcomes

  1. Number of Participants diagnosed with malignant lesions

    Time frame: 6 to 8 weeks from the intervention

    Compare the detection of malignant lesions between PDD and WLC using high-definition (HD) equipment during both primary TURB and re-TURB

  2. The European organization for reasearch and treatment of cancer quality of life questionnaire for patients with non-muscle invasive bladder cancern

    Time frame: from date of randomization until 20 weeks from randomization

    The scale range from 24 (better outcome) to 96 (worse outcome)

  3. EQ-5D-5L

    Time frame: from date of randomization until 20 weeks from randomization

    The scale range from 5 (better outcome) to 25 (worse outcome)

  4. EQ VAS

    Time frame: from date of randomization until 20 weeks from randomization

    A self-rating question of overall health status, measured on a 0 (worse outcome) to 100 (better outcome) visual analogue scale

  5. Adverse events

    Time frame: from date of randomization until 20 weeks from randomization

    Assess treatment changes and adverse events associated with each technique

Study contacts

Contact information is provided by the study sponsor or research team.

Francesco Soria

CONTACT

[email protected]

0116336594

Lisa Giacometti

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

A.O.U. Città della Salute e della Scienza

Other

Collaborators

  • Photocure

Registry information

Official study title

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

Acronym: TUR_BLUE

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Aug 12, 2024
Registry last updated
Aug 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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