The Impact of PDD During TURB for NMIBC

NCT06548438 | Not Yet Recruiting Phase 4

• 1 other identifier: CDS01FS
• Study Type: interventional
• Target: 300
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Bladder Cancer

Keywords

TURB; re-TURB; photodynamic diagnosis-PDD; Hexvix

Outcome Measures

Primary Outcomes (1)

• Residual disease and/or upstaging

  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

  6 to 8 weeks from the intervention

Secondary Outcomes (5)

• Number of Participants diagnosed with malignant lesions

  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

  from date of randomization until 20 weeks from randomization

• EQ-5D-5L

  from date of randomization until 20 weeks from randomization

• EQ VAS

  from date of randomization until 20 weeks from randomization

• Adverse events

  from date of randomization until 20 weeks from randomization

Study Arms (2)

Photodynamic diagnosis using Hexvix

EXPERIMENTAL

Transurethral resection of the bladder (TURB) is performed using photodynamic diagnosis (PDD) which involves the of use the study drug (Hexvix) to allow for better visualisation and subsequent resection

Procedure: Transurethral resection of the bladder performed with PDD tecnique and Hexvix

White light

NO INTERVENTION

Transurethral resection of the bladder (TURB) is performed using the standard white light procedure

Interventions

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.

Photodynamic diagnosis using Hexvix

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• A.O.U. Città della Salute e della Scienza: lead
• Photocure: collaborator

MeSH Terms

Conditions

Urinary Bladder Neoplasms

Interventions

5-aminolevulinic acid hexyl ester

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases

Study Officials

• Francesco Soria

  AOU Città della Salute e della Scienza

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Francesco Soria

CONTACT

0116336594; francesco.soria@unito.it

Lisa Giacometti

CONTACT

lisa.giacometti@cpo.it

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Randomised controlled trial. Randomization will be stratified based on the dedicated surgeon performing the procedure. Allocation will be at a 1:1 ratio between the two arms

Study Record Dates

• First Submitted: July 29, 2024
• First Posted: August 12, 2024
• Study Start: September 1, 2024
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: August 12, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data will be available after 6 months from major results publication and for the following 5 years
• Access Criteria: Data requests should be submitted to the corresponding author for consideration