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Feasibility of Photodynamic Diagnosis Using Intravesical Hexaminolevulinate with Sub‑One‑Hour Instillation in Patients with Primary or Recurrent Papillary 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

The study looks at people who have primary or recurrent papillary bladder cancer. The treatment being tested is an intravesical solution that contains the active substance hexaminolevulinate, sold under the name HEXVIX®. After the solution is placed directly into the bladder, a special imaging method called blue light cystoscopy, which is part of photodynamic diagnosis, is used to make any cancer cells glow. The purpose of the study is to evaluate how clearly the tumors light up when the examination begins 30 minutes after the solution is instilled.

Participants will receive the bladder‑instilled solution, wait about half an hour, and then undergo the blue‑light examination. Doctors will record how strong the glow appears and compare it with the view under normal white light, noting any additional tumors or early‑stage lesions that are seen. The study will also monitor participants for any side effects or complications during the procedure.

The research process

The trial runs in 9 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Enrollment and baseline assessment

    After agreeing to take part, personal and medical information is recorded to confirm the presence of primary or recurrent papillary bladder cancer.

    The study team reviews the eligibility criteria and explains the planned procedure in simple language.

  2. Step 2

    Pre‑procedure preparation

    On the day of the visit, you are asked to empty your bladder completely.

    A thin tube (catheter) is gently inserted through the urethra into the bladder to allow the medication to be delivered.

  3. Step 3

    Administration of <b>hexvix</b> (<b>intravesical instillation</b>)

    A solution containing 85 mg of hexaminolevulinate (hexvix) is placed into the bladder through the catheter.

    The exact amount and time of the instillation are recorded by the medical staff.

  4. Step 4

    Waiting period after instillation

    You remain lying down while the medication is absorbed by any cancer cells in the bladder.

    The protocol requires at least a 30‑minute interval before the next examination; a brief assessment may also be made at 15 minutes.

    During this time you may be asked to stay still and keep the catheter in place.

  5. Step 5

    <b>blue light cystoscopy</b> at 30 minutes

    After the 30‑minute waiting period, the doctor uses a special camera that emits blue light to look inside the bladder.

    The blue light causes cancerous tissue to glow, allowing the doctor to evaluate the tumor fluorescence quality.

    The findings are recorded using a short questionnaire.

  6. Step 6

    Optional assessment at 15 minutes

    If required by the study, a second blue light cystoscopy may be performed 15 minutes after the instillation to compare the glow intensity.

    The same evaluation method is used as for the 30‑minute assessment.

  7. Step 7

    Completion of the procedure

    The catheter is removed and the bladder is drained of any remaining solution.

    The doctor may perform a brief check with normal white light to compare findings.

  8. Step 8

    Post‑procedure observation

    You are monitored for a short period to ensure there are no immediate complications such as pain or bleeding.

    Any adverse events are recorded by the study team.

  9. Step 9

    Follow‑up visit

    A later appointment may be scheduled for the doctor to discuss the results of the fluorescence assessment and any further care recommendations.

    The study team records whether the planned instillation was performed as described in the protocol.

Who can join the trial?

4 criteria

  • Be a man or woman who is at least 18 years old.
  • Have a diagnosis of primary or recurrent papillary bladder cancer that has been confirmed by a cystoscopy (a camera exam of the bladder) or other imaging tests, and be scheduled for a procedure called TURB (trans‑urethral resection of bladder tumor) using the medicine Hexvix®.
  • Be covered by a health‑care system (for example, have health insurance).
  • Provide a signed informed consent before any study‑related procedures, showing you understand the study and agree to follow its requirements.

Who cannot join the trial?

14 criteria

  • Having a cystoscopy or bladder biopsy when no tumor had been found beforehand.
  • Having a flat bladder lesion that is not a papillary (finger‑like) tumor.
  • Having undergone a maximal transurethral resection of bladder (TURB) for a tumor that has grown into the bladder muscle before receiving combined radiation and chemotherapy.
  • Having any other TURB procedure that does not require the study drug Hexvix to be placed in the bladder first.
  • Having a urethral stricture, which means a narrowing of the tube that carries urine out of the body.
  • Having had previous pelvic radiotherapy, meaning radiation treatment to the lower abdomen.
  • Having a serious medical problem that is not well controlled and that the doctor believes makes using the study drug unsafe.
  • Being pregnant, possibly becoming pregnant without reliable birth control, or breastfeeding.
  • Being allergic (hypersensitivity) to the active ingredient hexaminolevulinate hydrochloride or to any of the other ingredients in the medication.
  • Having a previous diagnosis of porphyria, a rare condition that affects the skin and nerves.
  • Having bladder inflammation caused by a long‑term urinary infection, a catheter left in place, or recent bladder treatments with BCG or chemotherapy.
  • Having a bladder that cannot hold enough fluid to retain the Hexvix solution.
  • Being an adult who is under legal protection such as guardianship, curatorship, or other judicial protection.
  • Being unable to attend the required medical follow‑up visits because of distance, personal circumstances, or psychological reasons.
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Investigated drugs

Hexvix is a liquid that is placed directly into the bladder. It contains a substance called hexaminolevulinate, which makes cancer cells glow when a special blue light is used during a cystoscopy. In this study, the medicine is put into the bladder and left for a short time (about 30 minutes) before the doctor looks inside with the blue light. The goal is to see how well the glowing helps doctors spot bladder tumors quickly.

What is already known about the treatment

HEXVIX 85 mg, poudre et solvant pour solution intravésicale - It is given as a sterile solution that is poured directly into the bladder (intravesical administration) and left for about 30 minutes before a blue‑light cystoscopy is performed. Hexvix contains hexaminolevulinate, a pro‑drug that bladder cells change into a fluorescent substance, making cancerous areas glow under blue light. The product is already approved in many countries for photodynamic diagnosis of bladder cancer and is well documented in the medical literature. It is classified as a photosensitizing agent used for photodynamic diagnostic procedures.

Investigated diseases

Primary or recurrent papillary bladder cancer - It is a type of bladder cancer that forms finger‑like growths on the inner lining of the bladder. The tumors are usually limited to the superficial layer but can infiltrate deeper tissue as they enlarge. After an initial tumor is removed, new growths may develop in the same area, which is called recurrence. Over time the disease can progress to larger or multiple lesions if not identified early.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2026-526917-27-00Protocol codeHex-SUB1-IPC 2025-06Estimated enrolment50 patientsSponsorInstitut Paoli Calmettes

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