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Hexaminolevulinate

Clinical trials are investigating Hexaminolevulinate in people with non-muscle invasive bladder cancer. These studies look at whether it helps doctors remove bladder tumors more completely and reduce the need for repeat surgery. They mainly focus on safety-related study procedures and how well the surgery works in selected patient groups.

Table of contents

Trial overview

Two authorised Phase 3 clinical trials are studying Hexaminolevulinate in bladder cancer surgery.[1][2] Both trials focus on non-muscle invasive bladder cancer, which means the cancer has not grown into the muscle layer of the bladder.[1][2]

These studies compare a photodynamic diagnosis approach during transurethral resection with standard white-light surgery.[1][2] The main question is whether this approach helps doctors remove more disease and reduce the need for repeat surgery.[1][2]

Who is being studied

The target population in both trials is people with non-muscle invasive bladder cancer (NMIBC).[1][2] One trial lists the condition as “Not muscular invasive bladder cancer,” and the other uses the term NMIBC.[1][2]

These studies are designed for patients who are having bladder tumor surgery and may need a second look operation later.[1][2] The second trial explains that it is trying to identify patients who could safely avoid an unnecessary repeat resection.[2]

How the trials are designed

Both studies are interventional, which means the research team assigns a treatment strategy and then measures the results.[1][2] Both are also Phase 3 studies, so they compare the research approach with standard care in larger patient groups.[1][2]

In NCT06548438, the study compares PDD during TURB with white-light cystoscopy (WLC).[1] The trial includes 300 participants and is focused on the completeness of the first tumor removal.[1]

In 2023-507307-64-00, the study compares a primary PDD-guided TURBT strategy with the standard pathway that includes white-light resection and a repeat resection when needed.[2] This trial includes 258 participants and looks at whether some patients can avoid a second operation.[2]

Main endpoints

The main endpoint in NCT06548438 is the proportion of patients with residual tumor or a new diagnosis of carcinoma in situ at the time of repeat TURB.[1] Residual tumor means cancer still found after the first surgery, and carcinoma in situ means an early flat cancer change in the bladder lining.[1]

The main endpoint in 2023-507307-64-00 is the relative proportion of patients with early bladder cancer recurrence at the first follow-up cystoscopy.[2] Early recurrence is defined differently in the two study arms because the treatment timelines are not the same.[2]

Both trials are therefore measuring how well the surgery removes visible and hidden disease, not just whether the procedure can be done.[1][2]

What the trials try to show

The first study aims to compare the completeness of TURB with PDD against TURB with white light.[1] It asks whether the PDD-guided approach leaves fewer patients with remaining tumor or upstaging at repeat surgery.[1]

The second study aims to provide strong evidence that a PDD-guided approach may be safe enough to reduce or avoid unnecessary repeat resections in selected NMIBC patients.[2] The brief summary says the investigators want to show that their approach is not oncologically inferior to standard care, meaning it should not be worse for cancer control.[2]

These studies are important because they focus on a practical question in bladder cancer care: whether better imaging during surgery can improve treatment and possibly reduce extra procedures.[1][2]

Key patient terms

  • TURBT is surgery through the urethra to remove a bladder tumor.[2]

  • Repeat resection means a second surgery after the first tumor removal to check for leftover disease.[1][2]

  • Follow-up cystoscopy is a later bladder check with a camera to look for cancer coming back.[2]

  • Standard of care means the usual treatment doctors already use in regular practice.[2]

  • Oncologically inferior means worse for cancer control, which the second trial aims to rule out.[2]

Trial ID Phase Condition studied Status Enrollment
NCT06548438 Phase 3 Not muscular invasive bladder cancer Authorised 300
2023-507307-64-00 Phase 3 Non-muscle invasive bladder cancer (NMIBC) Authorised 258

FAQ

  • What is being studied in Hexaminolevulinate trials? The trials are studying Hexaminolevulinate used during bladder tumor surgery. They compare surgery with this approach against standard white-light surgery to see which method finds and removes more disease.
  • Who can take part in these studies? The main target group is people with non-muscle invasive bladder cancer. Some studies also select patients who may need a second look surgery after the first tumor removal.
  • What phase are the trials? Both trials in the source data are Phase 3 studies. Phase 3 trials usually compare a new approach with standard care in larger groups of patients.
  • What do the trials measure? They measure how often tumor is left behind, how often cancer is found again early, and whether a repeat resection is needed. One study also looks at carcinoma in situ, which is a flat early cancer change in the bladder lining.
  • Are these trials still active? Both trials listed in the source data are authorised. That means they have been approved to take place.

Ongoing Clinical Trials on Hexaminolevulinate

  • Study on Hexaminolevulinate for Patients with Non-Muscle Invasive Bladder Cancer to Reduce Need for Second Surgery

    Recruiting

    1 1 1 1
    Investigated drugs:
    Italy

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

    Not yet recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    Italy

Glossary

  • Non-muscle invasive bladder cancer (NMIBC): Bladder cancer that has not grown into the muscle layer of the bladder wall. It is often treated with surgery through the urethra.
  • Transurethral resection of bladder tumor (TURBT): A surgery done through the urethra to remove a bladder tumor. It is a common first treatment for bladder cancer found inside the bladder.
  • Photodynamic diagnosis (PDD): An imaging method used during surgery to help doctors see bladder tumors more clearly. In these trials, it is compared with white-light surgery.
  • White-light cystoscopy: A standard way to look inside the bladder using normal light. It is used as the control or standard care in these studies.
  • Re-TURBT: A second bladder tumor removal surgery. It is done after the first surgery to check for any remaining tumor.
  • Residual tumor: Cancer tissue that is still present after the first surgery and has not been removed.
  • Carcinoma in situ (CIS): A flat, early form of bladder cancer found in the lining of the bladder. It can be harder to see during surgery.
  • Upstaging: When a cancer is found to be more advanced than first thought after more testing or surgery.
  • Cystoscopy: A procedure that lets doctors look inside the bladder with a thin camera.
  • Early recurrence: Cancer that comes back soon after treatment. In these trials, it is checked at the first follow-up cystoscopy.

References