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Study on the Use of 68Ga-FAPI-46 and Fludeoxyglucose (18F) for Diagnosing Pleural Mesothelioma in Patients

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What is this trial about?

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

This clinical trial is focused on studying a disease called pleural mesothelioma, which is a type of cancer that affects the lining of the lungs. The study will use a special imaging technique called FAPI PET to see how well it can detect and evaluate this cancer. FAPI PET involves using a substance called 68Ga-FAPI-46, which is injected into the body and helps to highlight cancer cells during imaging. This study will also compare FAPI PET with another imaging method called FDG PET, which uses a substance known as Fluor-18-FDG.

The purpose of the study is to see how accurate FAPI PET is in diagnosing and staging pleural mesothelioma. Participants will undergo imaging with both FAPI PET and FDG PET to compare the results. The study will look at how these imaging techniques can help in planning treatment and assessing how well the treatment is working. The study will also explore if FAPI PET can provide more detailed information about the cancer compared to traditional imaging methods.

Throughout the study, participants will receive injections of the imaging substances and undergo scans to capture images of the cancer. The study will track changes in the cancer over time, especially after a few rounds of cancer treatment. The results from FAPI PET will be compared to those from FDG PET to determine which method provides better information for managing pleural mesothelioma. The study aims to improve understanding of how these imaging techniques can be used to guide treatment decisions and improve outcomes for patients with this type of cancer.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, eligibility is confirmed based on criteria such as age, understanding of the study, and physical and mental ability to participate.

    Participants must have pleural lesions suspicious of pleural mesothelioma and be referred for a pleural biopsy.

  2. Step 2

    Initial imaging

    Participants undergo an FDG PET/CT scan as part of the diagnostic workup for suspicious pleural mesothelioma lesions.

    This imaging helps in assessing the primary tumor, regional lymph nodes, and any distant metastases.

  3. Step 3

    FAPI PET/CT scan

    Participants receive an intravenous infusion of 68Ga-FAPI-46, a solution for injection, to perform a FAPI PET/CT scan.

    This scan aims to evaluate the diagnostic accuracy of FAPI in malignant pleural mesothelioma for primary staging.

  4. Step 4

    Comparison of imaging results

    The results from the FAPI PET/CT scan are compared with those from the FDG PET/CT scan.

    The comparison focuses on the primary tumor, regional lymph nodes, and distant metastases to determine sensitivity and specificity.

  5. Step 5

    Treatment planning

    Based on the imaging results, the location for the intended pleural biopsy may be adjusted.

    The cancer stage is determined using the FAPI PET/CT results, which may lead to changes in the treatment plan.

  6. Step 6

    Follow-up imaging

    After 2-3 series of anticancer treatment, another FAPI PET/CT scan is conducted to assess changes in the tumor and surrounding areas.

    This helps in evaluating the response to treatment and adjusting the treatment plan if necessary.

  7. Step 7

    Long-term follow-up

    A 10-year follow-up is conducted to determine overall survival, recurrence-free survival, and progression-free survival.

    These outcomes are compared between FAPI PET/CT based markers and other clinical practice markers.

Who can join the trial?

5 criteria

  • Patients with pleural lesions that are suspected to be **pleural mesothelioma** and are referred for a pleural biopsy. A pleural biopsy is a procedure where a small sample of tissue is taken from the lining of the lungs to check for disease.
  • Have had or are currently having an **FDG PET/CT** scan as part of the process to diagnose a suspicious pleural mesothelioma lesion. An FDG PET/CT scan is an imaging test that helps to show how tissues and organs are functioning.
  • Considered physically and mentally able to take part in the research project.
  • Understands the information about the study and is able to give consent to participate in the project.
  • Must be 18 years old or older.

Who cannot join the trial?

4 criteria

  • Patients who are not diagnosed with Pleural Mesothelioma cannot participate. Pleural Mesothelioma is a type of cancer that affects the lining of the lungs.
  • Patients who are not within the specified age range cannot participate. The age range is typically defined by the study.
  • Patients who belong to certain clinical trial groups that are not included in this study cannot participate. Clinical trial groups are categories of patients based on specific characteristics.
  • Patients who are part of a vulnerable population cannot participate. A vulnerable population includes groups that may need special protection, such as children or the elderly.
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Investigated drugs

FAPI PET is a type of imaging test used in this clinical trial. It helps doctors see how well the body is responding to treatment for pleural mesothelioma, a type of cancer that affects the lining of the lungs. This test uses a special substance that highlights cancer cells, making them easier to see on a PET scan. The goal is to improve the accuracy of diagnosing and staging the cancer, as well as to evaluate how well the treatment is working.

What is already known about the treatment

FAPI PET – This medication is administered through a PET scan, which is a type of imaging test. It is currently being studied in clinical trials for its effectiveness in diagnosing and staging pleural mesothelioma, a type of cancer affecting the lining of the lungs. The main therapeutic indication is to improve the accuracy of diagnosis and staging of this cancer. FAPI works by targeting specific proteins in cancer cells, allowing for clearer imaging results. It is classified as a diagnostic agent in the field of nuclear medicine.

Investigated diseases

Pleural Mesothelioma – Pleural Mesothelioma is a type of cancer that affects the lining of the lungs, known as the pleura. It is primarily caused by exposure to asbestos fibers, which can lead to the development of malignant cells in the pleural tissue. The disease often begins with symptoms such as chest pain, shortness of breath, and persistent cough. As it progresses, it can cause fluid buildup around the lungs, known as pleural effusion, which exacerbates breathing difficulties. The cancer can spread to nearby tissues and organs, including the chest wall and diaphragm. Over time, it may also metastasize to distant parts of the body, complicating the condition further.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-514301-62-00Estimated enrolment70 patientsSponsorAalborg University Hospital

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).