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Title: Study of 5-Aminolevulinic Acid for detecting tumor tissue during surgery in patients with ovarian cancer

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What is this trial about?

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

This study focuses on patients with ovarian cancer and investigates the use of a medication called 5-aminolevulinic acid (also known as 5-ALA) during surgery. The medication comes as a powder that is mixed with liquid and taken by mouth before the surgical procedure. 5-ALA is designed to help surgeons better identify cancer tissue during the operation by making tumor areas visible in a special light.

The purpose of this research is to determine if using 5-ALA during surgery can help doctors find cancer tissue that might not be visible under normal lighting conditions or through physical examination. The medication is given as a single oral dose of up to 20 milligrams per kilogram of body weight before the surgery.

During the operation, surgeons will examine the surgical area using both normal and special lighting conditions to identify areas of cancer. They will document any additional cancer tissue found with the help of 5-ALA that would not have been detected otherwise. Tissue samples will be taken to confirm the presence of cancer cells. The study will also monitor patients for any side effects that may occur from using this medication.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Medication administration

    You will receive Gliolan, a medication in the form of an oral solution that contains aminolevulinic acid hydrochloride

    The solution needs to be taken by mouth before the surgical procedure

  2. Step 2

    Surgical procedure

    You will undergo a planned surgical treatment through laparotomy (a surgical cut in the abdomen)

    During the surgery, special imaging will be used to detect ovarian cancer tissue

    The surgical team will examine the areas using both normal light and special fluorescent imaging

    Any suspicious areas identified during the procedure may be removed for examination

  3. Step 3

    Post-surgical monitoring

    Your recovery will be monitored for 30 days after the surgery

    The medical team will track any side effects or complications that may occur

    Tissue samples taken during surgery will be analyzed in the laboratory

  4. Step 4

    Follow-up assessment

    The results of your surgery and tissue analysis will be evaluated

    Your cancer staging will be reviewed based on the surgical findings

    Any changes in your condition will be documented

Who can join the trial?

9 criteria

  • Must provide written informed consent to participate in the clinical trial
  • Must be female
  • Must be 18 years or older
  • Must have either:
    • Confirmed ovarian cancer, or
    • Suspected ovarian cancer, or
    • Recurring ovarian cancer (cancer that has returned after previous treatment)
    • Must be scheduled for surgical treatment through one of these procedures:
      • Staging laparotomy (surgery to determine how far cancer has spread), or
      • Debulking laparotomy (surgery to remove as much tumor as possible), or
      • Interval debulking (surgery performed after initial chemotherapy)

Who cannot join the trial?

10 criteria

  • Patients who are male (only females can participate)
  • Patients who are under 18 years old
  • Patients who are pregnant or breastfeeding
  • Patients with known allergies or hypersensitivity to 5-ALA (the imaging agent used in the study)
  • Patients with severe liver disease that could affect the metabolism of the study medication
  • Patients with severe kidney disease that could affect the elimination of the study medication
  • Patients who are unable to give informed consent
  • Patients who are participating in other clinical trials
  • Patients with conditions that could interfere with the imaging procedure
  • Patients who have received certain types of chemotherapy within the past 4 weeks
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Investigated drugs

5-Aminolevulinic Acid (5-ALA) is an imaging agent used during surgery. When given to patients before surgery, it helps surgeons see cancer cells more clearly during the operation. The substance is absorbed by cancer cells and makes them glow under special blue light, making it easier for surgeons to identify and remove tumors that might be difficult to see under normal light. This is particularly useful in ovarian cancer surgery where small tumors might otherwise be missed. This is not a treatment medication, but rather a diagnostic tool used to improve the accuracy of cancer surgery.

What is already known about the treatment

5-Aminolevulinic Acid (5-ALA) - A diagnostic imaging agent administered orally before surgery that helps surgeons better visualize cancer tissue during operations. This compound works by being metabolized into protoporphyrin IX, which accumulates in cancer cells and fluoresces under specific wavelengths of light, making tumors clearly visible during surgery. Currently approved and actively used in surgical procedures, particularly for detecting and visualizing malignant tissue in various types of cancer, including ovarian cancer. This substance belongs to the class of optical imaging agents and represents a significant advancement in intraoperative tumor detection technology, helping surgeons achieve more precise and complete tumor resection.

Investigated diseases

Ovarian Cancer - A disease that develops in the ovaries, which are part of the female reproductive system. It begins when abnormal cells in the ovaries start to multiply uncontrollably and form tumors. The cancer can spread from its original site to other parts of the body through local extension or through the bloodstream and lymphatic system. Early in the disease, many women experience few or subtle symptoms, which may include bloating, pelvic pain, or changes in bathroom habits. The disease can affect one or both ovaries, and in some cases can involve nearby tissues in the pelvis.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-510614-33-00Protocol codeGYN-202301Estimated enrolment30 patientsSponsorRheinische Friedrich-Wilhelms-Universitaet Bonn

sourced from the EU Clinical Trials Register and site verification

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