Bladder CancerPhase 4TUR_BLUENCT06548438
The Impact of PDD During TURB for NMIBC
A Phase 4 study testing Transurethral resection of the bladder performed with PDD tecnique and Hexvix in people with Bladder Cancer, run by A.O.U. Città della Salute e della Scienza.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bladder Cancer
- What is being tested?
- Transurethral resection of the bladder performed with PDD tecnique and Hexvix
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2024to 1 Sep 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Lisa Giacometti contact
About this study
Official title: The Impact of PDD During TURB for NMIBC: a Prospective Randomized Controlled 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
Read the detailed description
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).
- Conditions
- Bladder Cancer
- Being tested
- Transurethral resection of the bladder performed with PDD tecnique and Hexvix
- Keywords
- TURB, re-TURB, photodynamic diagnosis-PDD, Hexvix
- Medical subject headings
- Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transurethral resection of the bladder performed with PDD tecnique and HexvixProcedure or 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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 to 8 weeks from the intervention
Secondary outcomes (5)
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
Measured: 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
The scale range from 24 (better outcome) to 96 (worse outcome)
Measured: from date of randomization until 20 weeks from randomization
EQ-5D-5L
The scale range from 5 (better outcome) to 25 (worse outcome)
Measured: from date of randomization until 20 weeks from randomization
EQ VAS
A self-rating question of overall health status, measured on a 0 (worse outcome) to 100 (better outcome) visual analogue scale
Measured: from date of randomization until 20 weeks from randomization
Adverse events
Assess treatment changes and adverse events associated with each technique
Measured: from date of randomization until 20 weeks from randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2024
- Study start1 Sep 2024 (estimated)
- Primary completion31 Mar 2027 (estimated)
- Study completion1 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bladder CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- A.O.U. Città della Salute e della Scienza
- Sponsor type
- University, hospital or other
- Collaborators
- Photocure
- Responsible party
- Principal investigator, Francesco Soria, A.O.U. Città della Salute e della Scienza
- Investigators
- Francesco Soria, Principal investigator, AOU Città della Salute e della Scienza
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06548438
- Sponsor's protocol ID
- CDS01FS
- Acronym
- TUR_BLUE
- Status last verified
- Aug 2024
- First submitted
- 29 Jul 2024
- Last updated
- 12 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All Individual Participant Data requests should be submitted to the corresponding author for consideration. Access to deidentified participant data may be granted following review, after the publication of major results
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of PDD During TURB for NMIBC: a Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06548438
- Acronym / sponsor ID
- TUR_BLUE / CDS01FS
- Conditions
- Bladder Cancer
- Keywords
- TURB, re-TURB, photodynamic diagnosis-PDD, Hexvix
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- A.O.U. Città della Salute e della ScienzaUniversity, hospital or other
- Collaborators
- Photocure
- Study start
- 1 Sep 2024 (estimated)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 1 Sep 2027 (estimated)
- First posted
- 12 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
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).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| Photodynamic diagnosis using Hexvix | Experimental | Procedure: Transurethral resection of the bladder performed with PDD tecnique and HexvixTransurethral 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 |
| White light | No intervention | –Transurethral resection of the bladder (TURB) is performed using the standard white light procedure |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transurethral resection of the bladder performed with PDD tecnique and HexvixFor 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. | Procedure or surgery | Photodynamic diagnosis using Hexvix |
Primary outcome
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
5 secondary outcomes
Number of Participants diagnosed with malignant lesions
Time frame: 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
Time frame: from date of randomization until 20 weeks from randomization
EQ-5D-5L
Time frame: from date of randomization until 20 weeks from randomization
EQ VAS
Time frame: from date of randomization until 20 weeks from randomization
Adverse events
Time frame: from date of randomization until 20 weeks from randomization
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2024.
- Individual participant dataSharing planned: Yes. All Individual Participant Data requests should be submitted to the corresponding author for consideration. Access to deidentified participant data may be granted following review, after the publication of major results
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lisa Giacometti contact
Francesco Soria principal investigator
AOU Città della Salute e della Scienza
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Transurethral resection of the bladder performed with PDD tecnique and Hexvix in people with Bladder Cancer, run by A.O.U. Città della Salute e della Scienza.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 12 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Francesco Soria (0116336594, francesco.soria@unito.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Residual disease and/or upstaging (time frame: 6 to 8 weeks from the intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2024.