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Study on 68Ga-FAPI-46 for Assessing Fibroblast Activation in Patients with Solid Tumors

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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 solid tumors, which are abnormal masses of tissue that usually do not contain cysts or liquid areas. The trial will use a special imaging technique called 68Ga-FAPI-46 PET-CT. This method involves a solution for infusion that contains a substance known as 68Ga-FAPI-46. The purpose of the study is to evaluate how well this imaging technique can detect and assess the activity of fibroblasts, which are cells that play a role in the formation of connective tissue, in patients with solid tumors. This is particularly useful when other imaging methods, like 18F-FDG PET scans, provide unclear or inconclusive results.

Participants in the study will receive the 68Ga-FAPI-46 solution through an intravenous infusion, which means it will be administered directly into a vein. The study will monitor the uptake of this solution in the body to determine if it highlights areas of interest within the tumors. The trial will also assess the safety of the procedure by tracking any side effects experienced by participants. The study aims to gather information on how effective this imaging method is in identifying and evaluating different types of solid tumors.

The trial will continue until the end of October 2025, with participants being recruited from May 2023. The results will help determine the proportion of patients with positive findings using the 68Ga-FAPI-46 PET-CT method, which could provide valuable insights into the diagnosis and management of solid tumors. This study is an important step in improving the understanding and treatment of these types of tumors by using advanced imaging techniques.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment

    Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying the presence of solid tumors through histological or cytological analysis. If a biopsy is not feasible, a CT or MRI scan strongly suggesting an oncological lesion is required.

    Eligibility criteria include being 18 years or older, having an ECOG performance status of 2 or less, and for females, not being pregnant or breastfeeding. Effective birth control methods are mandatory for participants of childbearing potential.

  2. Step 2

    Informed consent

    Participants must provide informed consent, indicating their willingness and ability to participate in the study.

  3. Step 3

    68Ga-FAPI-46 PET/CT scan

    The main procedure involves a 68Ga-FAPI-46 PET/CT scan. This scan is used to assess fibroblast activation in solid tumors. The scan helps in evaluating the sensitivity of the imaging technique in detecting tumors.

    The solution for infusion is administered intravenously. The scan aims to identify positive lesions where the concentration of the radioligand in the target tissue exceeds that in adjacent tissues.

  4. Step 4

    Evaluation of results

    The primary endpoint is the detection rate of 68Ga-FAPI-46 PET/CT. A positive result is defined as having at least one positive lesion. The evaluation includes assessing the primary tumor, lymph nodes, and metastasis.

    Secondary endpoints involve analyzing the proportion of positive patients and lesions for each tumor histology and site, as well as measuring the uptake of 68Ga-FAPI-46.

  5. Step 5

    Safety monitoring

    Safety is monitored by recording any adverse events from grade 1 to 4 according to CTCAE version 5.0. This monitoring continues until 30 days after the PET/CT scan.

Who can join the trial?

6 criteria

  • Patients must have **solid tumors**, which are abnormal masses of tissue that can occur in any part of the body. If a biopsy, which is a procedure to remove a small piece of tissue for testing, is not possible for technical reasons or due to risk, patients may still join if a CT or MRI scan strongly suggests a cancerous lesion.
  • The patient must have had an **18F-FDG PET/CT scan** or other imaging tests that are unclear or inconclusive. These are special scans that help doctors see how tissues and organs are functioning.
  • Both males and females can participate, but they must be **18 years or older**.
  • The patient must have an **ECOG performance status** of 2 or less. This is a scale used to assess how a patient's disease is affecting their daily living abilities, with lower numbers indicating better functioning.
  • Female participants must not be pregnant or breastfeeding. If they can have children, they must use highly effective birth control methods during the study and for at least 6 months after the last treatment. Male participants and their female partners must also use two acceptable methods of birth control, including a condom, during the study and for 6 months after the last treatment.
  • The participant must be willing and able to give **informed consent**, which means they understand the study and agree to participate.

Who cannot join the trial?

8 criteria

  • Patients who are pregnant or breastfeeding cannot participate.
  • Individuals with severe kidney or liver problems are excluded. These are important organs that help filter and process substances in the body.
  • Patients who have had another type of cancer in the past, except for certain skin cancers, are not eligible.
  • People who have had a major surgery or a significant injury within the last 4 weeks are not allowed to join.
  • Individuals who are currently participating in another clinical trial are excluded.
  • Patients with any condition that the study doctors believe would make it unsafe for them to participate are not eligible.
  • People who have an allergy to the substances used in the study cannot take part.
  • Individuals who cannot follow the study procedures or attend the required visits are excluded.
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Investigated drugs

68Ga-FAPI-46 is a radiotracer used in PET-CT scans to help visualize fibroblast activation in solid tumors. It is designed to provide detailed images that can help doctors assess the risk and characteristics of tumors, especially when other imaging methods like 18F-FDG PET scans are unclear or inconclusive.

What is already known about the treatment

68Ga-FAPI-46 – This medication is administered through an injection and is used in PET-CT scans to assess fibroblast activation in solid tumors. It is currently being studied in clinical trials to determine its effectiveness in providing clearer imaging results compared to traditional methods. The main therapeutic indication is for patients with solid tumors where other imaging techniques have been inconclusive. At the molecular level, 68Ga-FAPI-46 targets fibroblast activation protein, which is often overexpressed in cancerous tissues, allowing for enhanced imaging of tumor sites. It is classified as a radiopharmaceutical used in diagnostic imaging.

Investigated diseases

Solid Tumors – Solid tumors are abnormal masses of tissue that usually do not contain cysts or liquid areas. They can occur in various parts of the body, including organs and bones. These tumors are characterized by the uncontrolled growth of cells that form a solid mass. As they progress, they may invade nearby tissues and organs, potentially causing functional impairments. Solid tumors can be benign, meaning they do not spread to other parts of the body, or malignant, which means they have the potential to metastasize. The progression of solid tumors depends on their type, location, and growth rate.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-511659-17-00Protocol codeIRST100.59Estimated enrolment200 patientsSponsorIstituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l.

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