Health TrialsbyHealthPanel

The Impact of PDD During TURB for NMIBC

ConditionBladder Cancer
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorA.O.U. Città della Salute e della Scienza

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Transurethral resection of the bladder performed with PDD tecnique and Hexvix

    Procedure/Surgery

    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.

Treatment groups

300 Participants
are divided into 2 treatment groups
Group A: Photodynamic diagnosis using HexvixExperimental treatment 1 intervention
Group B: White lightNo intervention 0 interventions

Trial outcomes

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

Time frame
6 to 8 weeks from the intervention

Secondary outcomes

1

Number of Participants diagnosed with malignant lesions

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

Time frame
6 to 8 weeks from the intervention
2

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

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

Time frame
from date of randomization until 20 weeks from randomization
3

EQ-5D-5L

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

Time frame
from date of randomization until 20 weeks from randomization
4

EQ VAS

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

Time frame
from date of randomization until 20 weeks from randomization

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

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

Lead sponsor

Photocure

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: