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Phase II study of [68Ga]BED003 PET imaging and liquid biopsy for staging bladder cancer in bladder cancer patients

Verified siteInvestigationalNo placebo
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What is this trial about?

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

The study involves patients with bladder cancer. The investigation uses a diagnostic approach that combines a special imaging technique called FAPI PET imaging with a blood test known as liquid biopsy. The imaging requires an injection of a radiotracer named [68Ga]BED003 injection, which contains the substance GA68-ONCOFAP. The radiotracer is given through a vein and then a scanner takes pictures that show areas where the cancer may be active.

The purpose of the study is to assess whether this combined method can more accurately determine the stage of the disease than standard scans such as CT, MRI, and the commonly used tracer [18F]FDG. Participants will receive the injection, undergo the imaging session, and provide a blood sample for the biopsy. The study follows them for a short period to compare the findings from the new approach with the results of the usual imaging.

PET imaging is a type of scan that uses a tiny amount of radioactive material to highlight active cells, while a liquid biopsy looks for cancer‑related material in the bloodstream, avoiding the need for tissue removal. The information gathered helps doctors decide the best treatment plan.

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 Confirmation

    After agreeing to take part, you sign the informed consent form and become an official participant in the Phase II study.

  2. Step 2

    Baseline Clinical Evaluation

    The study team records your medical history, performs a physical examination, and obtains routine laboratory tests to establish a baseline before any study procedures.

  3. Step 3

    Conventional Imaging

    You undergo standard imaging studies such as CT (computed tomography), MRI (magnetic resonance imaging), or a conventional [18F]FDG PET scan. These images are used for comparison with the study imaging.

  4. Step 4

    Preparation for FAPI PET

    You are scheduled for a special PET scan that uses a fibroblast activation protein‑alpha inhibitor. No special preparation such as fasting is required unless instructed by the imaging center.

  5. Step 5

    [68Ga]BED003 Injection

    On the day of the scan, a healthcare professional injects a single dose of [68Ga]BED003 (also called ga68‑oncofap) into a vein. The dose is 250 MBq (megabecquerels) given as an intravenous bolus or short infusion.

  6. Step 6

    FAPI PET Scan

    Shortly after the injection, you lie on a scanner table while the PET camera acquires images of your bladder and surrounding tissues. The scan typically lasts about 30 to 60 minutes.

  7. Step 7

    Liquid Biopsy

    A blood sample is taken to analyze circulating tumor material. This test, called a liquid biopsy, is performed once during the study and is compared with the imaging results.

  8. Step 8

    Follow‑Up Visit

    After the imaging and blood test, you meet with the study physician to discuss the findings. The results help determine the stage of your bladder cancer and guide future treatment decisions.

  9. Step 9

    End of Study Participation

    You complete any remaining questionnaires or assessments required by the protocol. No further study‑specific procedures are performed after this visit.

Who can join the trial?

7 criteria

  • Be willing and able to sign a consent form that explains the study (informed consent).
  • Be a man or woman who has been diagnosed with bladder cancer that starts in the lining of the bladder (urothelial carcinoma), either a high‑grade non‑muscle‑invasive type (high‑grade NMIBC) or a muscle‑invasive type (MIBC).
  • Be 18 years old or older.
  • Have a good overall health score, meaning an ECOG performance status lower than 2 (you can perform most daily activities without needing help).
  • Be able to have the required scans and give blood and urine samples (imaging study procedures and blood/urine collection).
  • If you could become pregnant, you must use a reliable birth‑control method (highly effective contraception) from the time you are screened until one week after any study medication is given.
  • If you are part of the first sub‑group of the study, you must have a baseline FAPI PET scan and a liquid biopsy taken before starting any systemic (whole‑body) bladder cancer treatment.

Who cannot join the trial?

5 criteria

  • Pregnant or breast‑feeding women cannot take part.
  • Anyone who has had systemic treatment (medicine that works throughout the whole body) for another oncological disease (cancer) in the last two years is excluded.
  • People who have already had systemic (whole‑body) or locoregional (treatment aimed at a specific area) therapies for bladder cancer are not allowed, except for a special group of patients defined in the study. TURB (a common bladder surgery) does not count as an exclusion.
  • If a person has a condition such as severe claustrophobia (extreme fear of tight spaces) or severe, uncontrolled psychiatric disorders (serious mental health problems) that the investigators feel would make participation unsafe or difficult, they cannot join.
  • Being in another clinical trial is not automatically a reason to be excluded, but if a person is already in an interventional study (a trial testing a new treatment) and the researchers think it could affect safety, following the study rules (protocol), or the results, they may be excluded.
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Investigated drugs

  • [68Ga]BED003 injection

    is a special medicine that doctors give through a quick IV injection. It contains a tiny amount of a radioactive substance that looks for a protein called fibroblast activation protein‑alpha, which is often found in bladder cancer cells. After it is injected, a special scanner called a PET scanner can see where the medicine goes in the body, helping doctors see the exact size and spread of the cancer.

  • Liquid biopsy

    is a simple blood test that checks for tiny pieces of cancer DNA or other markers that tumors release into the bloodstream. By analyzing these markers, doctors can learn more about the cancer’s characteristics and how advanced it is, without needing extra invasive procedures.

What is already known about the treatment

[68Ga]BED003 injection - It is given as an intravenous bolus injection of a clear solution, usually 250 MBq. The agent is currently investigational and is being studied in clinical trials, so it is not yet approved for routine medical use. It is used to help doctors see bladder cancer and determine its stage by PET imaging. The compound binds to fibroblast activation protein on certain cells, and the attached gallium‑68 emits signals that the PET scanner can detect, classifying it as a radiopharmaceutical PET imaging agent.

Investigated diseases

Bladder cancer - A malignant growth that begins in the lining of the bladder and can grow into deeper layers of the bladder wall. As it enlarges, it may invade the muscle layer of the bladder, making it harder to remove. The cancer can then spread to nearby lymph nodes and other organs such as the pelvis or lungs. Early stages are usually confined to the inner lining, while later stages involve deeper tissue invasion and distant spread. The disease’s progression is typically assessed by imaging and tissue sampling to determine how far it has extended.
Trial detailsLast updated 12 Nov 2026
Age18+ yearsPhasePhase IITrial ID2026-526990-40-00Protocol codeFUTUREEstimated enrolment129 patientsSponsorUniversita' Vita-salute S. Raffaele

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