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New treatment option for Non-muscle-invasive Bladder Cancer
Official title Vesical Imaging-Reporting and Data System (VI-RADS) Followed by Photodynamic Trans-urethral Resection of Bladder Tumours (PDD-TURBT) to Avoid Secondary Resections (Re-TURBT) in Non-Muscle Invasive Bladder Cancers (NMIBCs)
ClinicalTrials.gov ID: NCT05962541
What this study is testing
What is PDD-TURBT with hexaminolevulinate (Hexvix®)?
PDD-TURBT with hexaminolevulinate (Hexvix®) is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for non-muscle-invasive bladder cancer.
Also referred to as Hexvix®.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Background: In European Association of Urology (EAU) Guidelines, the vast majority of non-muscle-invasive bladder cancers (NMIBCs) undergo a primary transurethral resection of the bladder tumor (TURBT) followed by a repeat TURBT (Re-TURBT). The Re-TURBT is recommended due to the possibility of residual bladder cancer but is unnecessary in many cases by constituting overtreatment.
- Phase 4: studies an already-approved treatment
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Female and Male patients at least 18 years old referred for clinical suspicion of primary or recurrent BCa who have been advised to undergo TURBT.
- Patients with a TUR-confirmed diagnosis of NMIBC and candidate for second look and resection (Re-TURBT) according to EAU Guidelines [6].
- No imaging evidence (i.e., mpMRI/VI-RADS score 1 or 2) of muscle-invasive, locally advanced, or metastatic BCa (i.e., only confirmed CIS, Ta, T1, N0...
- Patients who did or did not receive previous BCG immunotherapy (i.e., BCG naïve and non-naïve patients).
- Fit to undergo all procedures listed in protocol.
You likely can't join if
- Contraindication to TURBT and/or Re-TURBT.
- Initial TURBT diagnosis of MIBC (i.e., T2) or locally advanced BCa (i.e., T3-T4).
- Preoperative evidence of metastatic disease (i.e., cN1 - N3 and/or cM1).
- Visual evidence of low-risk NMIBC (solitary tumor, \< 1 cm) before initial TURBT.
- Visual evidence of MIBC on preliminary cystoscopy (i.e., non-papillary or sessile mass attached directly by its base without a stalk).
- TURBT diagnosis of NMIBCs not eligible for Re-TURBT according to EAU Guidelines (i.e., Ta-LG; Ta-HG with detrusor muscle in the specimen; primary...
See the full eligibility criteria
- Female and Male patients at least 18 years old referred for clinical suspicion of primary or recurrent BCa who have been advised to undergo TURBT.
- Patients with a TUR-confirmed diagnosis of NMIBC and candidate for second look and resection (Re-TURBT) according to EAU Guidelines [6].
- No imaging evidence (i.e., mpMRI/VI-RADS score 1 or 2) of muscle-invasive, locally advanced, or metastatic BCa (i.e., only confirmed CIS, Ta, T1, N0, M0 will be considered eligible).
- Patients who did or did not receive previous BCG immunotherapy (i.e., BCG naïve and non-naïve patients).
- Fit to undergo all procedures listed in protocol.
- Able to provide written informed consent.
- Contraindication to TURBT and/or Re-TURBT.
- Initial TURBT diagnosis of MIBC (i.e., T2) or locally advanced BCa (i.e., T3-T4).
- Preoperative evidence of metastatic disease (i.e., cN1 - N3 and/or cM1).
- Visual evidence of low-risk NMIBC (solitary tumor, \< 1 cm) before initial TURBT.
- Visual evidence of MIBC on preliminary cystoscopy (i.e., non-papillary or sessile mass attached directly by its base without a stalk).
- TURBT diagnosis of NMIBCs not eligible for Re-TURBT according to EAU Guidelines (i.e., Ta-LG; Ta-HG with detrusor muscle in the specimen; primary CIS) [6].
- Concomitant Upper tract (kidney or ureteric) tumours on imaging.
- Contraindication to adjuvant intravesical BCG immunotherapy.
- Unfit to undergo any procedures listed in protocol.
The study team makes the final eligibility decision.
Where it's taking place
- Rome, Lazio, Italy
Compensation & support
Compensation likely.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Rome, Lazio, Italy. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.