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Study on the Effectiveness of Hexaminolevulinate in Bladder Cancer Surgery for Patients with Non-Muscle Invasive Bladder Cancer

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a type of bladder cancer known as non-muscle invasive bladder cancer (NMIBC). The study will use a treatment called Hexvix, which contains the active substance hexaminolevulinate. This treatment is used as an intravesical solution, meaning it is administered directly into the bladder. The purpose of the study is to compare two different methods used during a surgical procedure called Transurethral Resection of Bladder Tumor (TURB). One method uses a special light technique called Photodynamic Diagnosis (PDD), and the other uses standard white light (WL).

The study will observe how well these methods help in removing the bladder tumor completely and whether there is any remaining cancer or changes in the cancer stage when the procedure is repeated. Participants will be randomly assigned to either the PDD or WL group. The study will also look at the recurrence of cancer three months after the procedure, the quality of life of participants, and any side effects experienced. Quality of life will be assessed using specific questionnaires designed for bladder cancer patients.

The trial aims to provide valuable information on the effectiveness of using PDD compared to WL during TURB for patients with NMIBC. This could potentially lead to better treatment outcomes and improved quality of life for patients with this type of bladder cancer. The study is expected to continue until 2028, with recruitment starting in 2025.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, you will be required to provide a voluntarily signed informed consent. This is a document that confirms your agreement to participate in the study and that you understand the procedures involved.

    You must be at least 18 years old and scheduled for a procedure called transurethral resection of bladder tumor (TURB) for a suspected bladder cancer larger than 1.5 cm.

  2. Step 2

    Initial procedure

    You will undergo a procedure called TURB, which is a surgical method used to diagnose and treat bladder cancer.

    During this procedure, a special solution containing hexaminolevulinate will be used. This solution is administered directly into the bladder through a process called intravesical use.

  3. Step 3

    Follow-up assessments

    After the initial procedure, you will be monitored for any residual disease or changes in your condition. This may involve additional procedures or imaging tests.

    Your quality of life will be assessed using specific questionnaires at different time points: after randomization, one month after the first TURB, and three months after any additional procedures.

  4. Step 4

    Additional procedures

    If necessary, a second procedure called re-TURB may be performed to ensure all cancerous tissue has been removed.

    The study aims to compare the effectiveness of using the special solution with standard methods in terms of detecting any remaining cancer.

  5. Step 5

    Completion of study

    The study is expected to continue until April 2028, but your participation will depend on your individual treatment plan and follow-up schedule.

    Throughout the study, any adverse events or changes in your condition will be closely monitored and addressed by the medical team.

Who can join the trial?

6 criteria

  • The patient must have non-muscular invasive bladder cancer.
  • The patient must have voluntarily signed informed consent, which means they agree to participate in the study after being fully informed about it.
  • The patient must be 18 years or older.
  • The patient must be planned for a procedure called TURB (Transurethral Resection of the Bladder) for a primary bladder cancer that is suspected to be larger than 1.5 cm. This size is determined using an abdomen ultrasound or a flexible cystoscopy (a procedure where a thin tube with a camera is used to look inside the bladder).
  • Both male and female patients can participate.
  • The study does not include vulnerable populations, which means groups that might need special protection or care.

Who cannot join the trial?

3 criteria

  • Patients with **muscular invasive bladder cancer** cannot participate. This means if the cancer has spread into the muscle layer of the bladder, the patient is not eligible.
  • Patients who are not within the specified age range cannot participate. The study is open to certain age groups only.
  • Patients who are part of a vulnerable population are not eligible. This refers to groups of people who might be at a higher risk of harm or exploitation.
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Investigated drugs

  • PDD

    stands for Photodynamic Diagnosis. It is a special technique used during bladder cancer surgery to help doctors see cancerous tissues more clearly. In this trial, PDD is used during a procedure called TURB, which stands for Transurethral Resection of Bladder Tumor. PDD involves using a light-sensitive drug that makes cancer cells glow under a special blue light, helping the surgeon to remove the tumor more completely.

  • WL

    stands for White Light. It is the standard method used during bladder cancer surgery to visualize the bladder and any tumors present. In this trial, WL is used during the TURB procedure to help the surgeon see and remove the bladder tumor. Unlike PDD, WL does not use any special drugs or lights to enhance the visibility of cancer cells.

What is already known about the treatment

PDD (Photodynamic Diagnosis) – PDD is a method used during bladder cancer surgery to help doctors see cancerous tissues more clearly. It is administered by applying a special light-sensitive drug to the bladder, which makes cancer cells glow under a specific type of light. This technique is currently being studied in clinical trials to determine its effectiveness in improving the thoroughness of bladder cancer surgery. The main therapeutic indication for PDD is non-muscle invasive bladder cancer, where it helps in identifying and removing cancerous tissues more completely. At the molecular level, the light-sensitive drug used in PDD accumulates in cancer cells and, when exposed to a specific light, emits a fluorescent glow, making it easier for surgeons to distinguish cancerous tissues from healthy ones. PDD is classified under diagnostic techniques in oncology.

Investigated diseases

Non-muscle invasive bladder cancer – This type of bladder cancer is characterized by cancer cells that are confined to the inner layers of the bladder wall and have not spread into the muscle layer. It often begins with the formation of small growths or tumors on the bladder lining. As the disease progresses, these tumors can grow in size and number, potentially leading to symptoms such as blood in the urine, frequent urination, or pain during urination. The progression of the disease can vary, with some tumors remaining superficial and others potentially becoming more aggressive. Monitoring and regular check-ups are crucial to track any changes in the condition. The disease can recur, necessitating ongoing surveillance and management.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-514316-27-00Protocol codeCDS01FSEstimated enrolment300 patientsSponsorAzienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino

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