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The Impact of PDD During TURB for NMIBC

NCT06548438 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2024-08-12

No results posted yet for this study

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

Interventions

PROCEDURE

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 and subsequent resection.

Sponsors & Collaborators

  • Photocure

    collaborator INDUSTRY

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

    lead OTHER

Principal Investigators

  • Francesco Soria · AOU Città della Salute e della Scienza

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-09-01
Primary Completion
2027-03-31
Completion
2027-09-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06548438 on ClinicalTrials.gov