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Feasibility Study of Fluorescence Bronchoscopy Using bevacizumab-800CW in Patients with Suspected Lung 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 focuses on people who have a lung lesion or lymph node that looks like it could be cancer, known as lung cancer. A specially labeled version of a medicine called bevacizumab-800CW will be given through an intravenous injection. After the medicine is given, doctors will perform a procedure called bronchoscopy, where a thin tube with a light and camera is passed down the airway. During this procedure a type of fluorescence imaging will be used, which means a special light helps the medicine glow so that abnormal tissue can be seen more clearly. The purpose of the study is to assess the feasibility of this approach for identifying malignant lung lesions and abnormal lymph nodes.

Participants will receive the study drug, then undergo the bronchoscopy with the glow‑light technique. Any tissue that appears abnormal may be sampled in the usual way for laboratory analysis. After the procedure, patients will be monitored for a short period to check for any side effects from the medicine or the procedure. The overall time spent in the study is limited to the day of the procedure and a brief follow‑up visit.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial visit and consent

    You attend the study site on the day you are assigned to the trial and sign the informed consent form.

    The study staff confirms eligibility based on the presence of a suspected malignant lung lesion.

  2. Step 2

    Administration of bevacizumab-800cw

    A single intravenous injection of bevacizumab-800cw is given.

    The medication is supplied as a 25 mg/ml solution; the dose is 25 mg, delivered in a 1 ml volume.

    The infusion is performed in a clinical setting and lasts a few minutes.

  3. Step 3

    Fluorescence bronchoscopy

    After the infusion, you undergo a bronchoscopy, a procedure that inserts a thin tube through the airway to view the lungs.

    The bronchoscope is equipped for fluorescence imaging to detect the fluorescent signal from the drug that highlights malignant tissue.

    The imaging is performed on the pulmonary nodule or suspicious lymph node.

  4. Step 4

    Tissue sampling during bronchoscopy

    While the bronchoscope is in place, small tissue samples are collected from the lesion and any lymph nodes that show fluorescence.

    The samples are sent for histopathology or cytology to confirm the diagnosis.

  5. Step 5

    Post‑procedure safety monitoring

    You are observed for a period after the bronchoscopy for any immediate adverse reactions to the drug or the procedure.

    Any symptoms are recorded and graded according to standard safety criteria.

  6. Step 6

    Final study assessment

    The results of the fluorescence imaging and the pathology analysis are compared.

    The study team documents the safety findings and the overall feasibility of the imaging method.

Who can join the trial?

4 criteria

  • You must sign a written informed consent form, which means you agree to join the study after the doctors explain what will happen.
  • You must be 18 years old or older.
  • You must have at least one lung lump called a pulmonary nodule that is either near the airway (intrabronchial or near‑to‑airway) or farther out in the lung (peripheral), and doctors think it could be cancer, even if it might be another type of tumor. This lump may be present with or without abnormal (called pathological) lymph nodes, which are small glands that can show disease.
  • You must be healthy enough to have a bronchoscopy, a test where a thin tube is passed into the breathing tubes to look at the lungs and take a small piece of tissue. The procedure may use virtual navigation (computer‑guided help) or endobronchial ultrasound (sound imaging), and it can be done with mild sleep medicine called propofol sedation or with full sleep called general anesthesia. The doctors will collect tumor material following normal care rules.

Who cannot join the trial?

3 criteria

  • History of infusion reactions to bevacizumab or other monoclonal antibodies (meaning you have previously had allergic‑type reactions when these medicines were given through an IV).
  • Medical or psychiatric conditions that make it hard for you to understand the study and give informed consent (meaning you cannot fully understand or agree to the trial procedures).
  • Pregnancy or breast‑feeding. Women who could become pregnant must have a negative pregnancy test on the day the tracer is given (a test showing they are not pregnant). This includes women who have not gone through menopause or who are less than two years after menopause.
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Investigated drugs

Bevacizumab is a medication that targets a protein that helps tumors grow new blood vessels. In this study it is given through an IV infusion before the bronchoscopy. The drug helps the fluorescent dye attach to any cancer cells, making them easier to see with special imaging equipment.

Fluorescence imaging with bevacizumab‑800CW is a technique where the bevacizumab drug is linked to a harmless fluorescent dye. During the bronchoscopy, doctors shine a light that makes the dye glow, allowing them to spot malignant lung lesions or affected lymph nodes that might be difficult to detect with normal vision.

What is already known about the treatment

Bevacizumab - It is administered as an intravenous infusion of a clear solution; the drug is approved and widely documented in medical literature. It is mainly used to treat various cancers such as lung, colon, and kidney cancers. It works by attaching to a protein called VEGF, which blocks the growth of new blood vessels that supply the tumor. It is classified as a monoclonal antibody that inhibits angiogenesis.

Investigated diseases

Lung cancer - Lung cancer is a disease where abnormal cells begin to grow in the lung tissue. It often starts in the lining of the airways and may appear as a small nodule or mass. As the cells multiply, they can invade surrounding lung structures and become larger. The disease can spread to nearby lymph nodes, and later may travel to other parts of the body through the bloodstream. The pattern of growth varies, with some lesions remaining limited while others expand and affect normal lung function.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-510793-24-00Protocol code20210028Estimated enrolment20 patientsSponsorUniversitair Medisch Centrum Groningen

sourced from the EU Clinical Trials Register and site verification

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