AuthorisedTherapeutic use (Phase IV)Interventional

The impact of PDD during TURB for NMIBC: a prospective randomized controlled trial

This study is for people with early-stage bladder cancer that hasn't spread deep into the bladder wall. We're investigating if using a special blue light during surgery (called 'photodynamic diagnosis' or PDD) helps surgeons find all the cancerous cells more effectively than standard white light. The aim is to see if PDD can reduce the amount of cancer left behind after the first operation and lower the chance of the cancer returning quickly. We'll be comparing patients who have this special light treatment with those who have the usual surgery to understand its benefits and any side effects. This research helps us improve how we treat this type of bladder cancer.

At a glance

Status

Authorised

Phase

Therapeutic use (Phase IV)

Sponsor

Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino

Enrolment target

300

Start

19 May 2025

Not muscular invasive bladder cancer

What is this study about?

This study is looking into a type of bladder cancer that's caught early and hasn't grown deep into the bladder muscle. It's called 'non-muscle invasive bladder cancer'. The main treatment for this is an operation to remove the cancer from the bladder. Doctors often use a special camera during this surgery to see inside the bladder and remove any abnormal areas.

We're testing a special approach called 'photodynamic diagnosis' (PDD). This involves putting a harmless liquid (called Hexvix) into the bladder before surgery. This liquid is absorbed by cancer cells, making them glow a bright pink or red under a special blue light that the surgeon uses during the operation. This is different from the usual surgery where doctors only use normal white light to spot the cancer.

The main goal of our study is to see if using this special blue light (PDD) helps surgeons find more cancer cells that might otherwise be missed. If they can find more cancer the first time, it might mean less cancer is left behind, and hopefully, reduce the chance of it growing back. We'll be comparing patients who have this blue light treatment with those who have the standard white light surgery to see if PDD makes a real difference in how much cancer is found and if it comes back sooner.

Key takeaways

Targets early-stage bladder cancer that hasn't spread deeply.
Compares standard surgery with a special blue-light technique (PDD) using Hexvix.
Aims to see if the blue light helps doctors find more cancer cells.
Measures if finding more cancer reduces recurrence and improves long-term outcomes.
Includes follow-up appointments and quality of life questionnaires.
Open to adults aged 18 and over, both men and women.

Who may be eligible?

This study is open to both men and women aged 18 or older. You might be able to join if you have been diagnosed with non-muscle invasive bladder cancer.

Before you can take part, the study team will need to check some things to make sure the study is right for you and that it's safe for you to participate. This will involve reviewing your medical history and current health.

It's important to remember that not everyone with bladder cancer will be able to join. There are specific health requirements that your doctor will discuss with you. If you're interested, you should talk to your hospital doctor or nurse, who can tell you more about whether this study might be suitable for your situation.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Have you been diagnosed with non-muscle invasive bladder cancer?
Are you able to attend follow-up appointments as required?
Are you able to fill out questionnaires about your health and quality of life?
Are you generally in good health apart from your bladder cancer?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you'll be put into one of two groups by chance (like flipping a coin). One group will receive the standard bladder surgery using white light, and the other group will have the surgery with the special blue light (PDD) using Hexvix. You won't be able to choose which group you're in. Before your surgery, for PDD, a liquid will be put into your bladder through a thin tube.

After your first surgery, some patients will have a second procedure, called a re-TUR, a few weeks later. This is a common practice for this type of bladder cancer to make sure all cancer cells have been removed. We will monitor your progress closely through a series of check-ups. You'll also be asked to fill out questionnaires about your quality of life at specific times: before your treatment, about a month after your first surgery, and about three months after your re-TUR (if you have one). The total time you'll be involved in the study will depend on your treatment plan and follow-up, but generally, it involves monitoring for several months.

Potential risks and benefits

Participating in this study might offer a potential benefit if the special blue light technique helps your surgeon find more cancer cells, which could lead to a more complete removal of the tumour and potentially reduce the chance of the cancer coming back. However, there's no guarantee of personal benefit, and for some, the standard treatment might be just as effective. Potential risks could include side effects from the Hexvix solution, such as bladder discomfort, or potential side effects related to any surgical procedure. You will be closely monitored for any adverse events. Remember, your participation is completely voluntary, and you have the right to withdraw from the study at any time without affecting your future medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Italy

Common questions

What is 'non-muscle invasive bladder cancer'?

It's an early form of bladder cancer that has not grown into the deep muscle layer of the bladder wall.

What is Hexvix?

Hexvix is a liquid that's put into the bladder before surgery. It helps make cancer cells glow when a special blue light is used, making them easier for the surgeon to see.

What does a 're-TUR' mean?

A re-TUR is a second operation, usually a few weeks after the first, to make sure all cancer has been removed and to check for any missed cells.

Will I definitely get the new treatment?

No. Patients are randomly assigned to either get the new blue light treatment or the standard white light treatment, like drawing lots.

How long will I be in the study?

You'll be monitored for several months, with visits for your surgeries, check-ups, and filling out questionnaires. The exact duration depends on your individual treatment pathway.