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Study on 68Ga-FAPI-46 for Imaging in Patients with Non-Metastatic Pancreatic Cancer

Verified siteInvestigationalNo placebo

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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 type of cancer known as non-metastatic pancreatic ductal adenocarcinoma. The trial will use a new imaging method involving a special substance called 68Ga-FAPI-46, which is given through an intravenous infusion. This substance is a radiotracer, which means it helps to create detailed images of the body using a technique called Positron Emission Tomography (PET). The purpose of the study is to explore how these images can be used to understand the patient's condition better and predict their future health outcomes.

Participants in the study will undergo repeated PET-CT scans, which combine PET imaging with computed tomography (CT) to provide a comprehensive view of the cancer. These scans will be done at the start of the study and at various points during the trial. The study aims to see if the images can help identify specific markers that indicate how the cancer might progress or respond to treatment. This could potentially lead to earlier and more accurate diagnosis and monitoring of pancreatic cancer.

The trial will track the time from diagnosis to any changes in the disease, such as progression or recurrence, as well as the time from surgery to any return of the disease. These outcomes will be assessed using routine CT scans, which are typically done every three months, although additional scans may be performed if needed. The study will continue until 2027, with the goal of improving the understanding and management of pancreatic cancer through 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.

Step 1
Initial visit
Upon joining the study, you will attend an initial visit. During this visit, you will receive detailed information about the trial and what to expect.
You will be asked to sign an informed consent form, confirming your understanding and willingness to participate.
Step 2
Baseline imaging
You will undergo a PET-CT scan using a new radiotracer called 68Ga-FAPI-46. This is an imaging test that helps visualize certain proteins in your body.
The radiotracer is administered through an intravenous infusion, which means it is injected into a vein. The procedure is designed to be safe and is closely monitored by medical professionals.
Step 3
Follow-up imaging
You will have additional PET-CT scans at specified intervals to monitor your condition. These scans help assess the progression of your disease and the effectiveness of the treatment.
The usual time interval between scans is three months, but additional scans may be performed if necessary, based on your doctor's assessment.
Step 4
Routine care assessments
Throughout the trial, you will continue to receive routine care, including regular CT scans to monitor your health.
These assessments are part of your standard medical care and help track any changes in your condition.
Step 5
End of trial
The trial is expected to conclude by July 15, 2027. At the end of the trial, your participation will be reviewed, and you will receive information about the results and any further steps.
Your doctor will discuss the outcomes with you and provide guidance on your ongoing care.

Who can join the trial?

5 criteria

Recent diagnosis (within the last month) of non-metastatic pancreatic ductal adenocarcinoma. This means the cancer is in the pancreas and has not spread to other parts of the body. The diagnosis must be confirmed by a test that examines cells or tissues (cyto/histologically proven) and must be shown as non-metastatic on a CT scan and MRI.
Participation in the HoMING prospective cohort study. This is another study that you must be enrolled in at the same time.
Must be over 18 years old.
Must be affiliated with a social security scheme. This means you need to be part of a system that provides health insurance or benefits.
Must have signed an informed consent form. This is a document that explains the study and confirms that you agree to participate.

Who cannot join the trial?

3 criteria

Patients with **metastatic** pancreatic ductal adenocarcinoma cannot participate. Metastatic means that the cancer has spread to other parts of the body.
Patients who are not within the specified age range cannot participate. The age range is typically defined in the study details.
Patients who are part of a vulnerable population cannot participate. A vulnerable population includes groups like children, pregnant women, or those unable to give consent.

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Institut Curie - Site Paris
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Paris, France

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Investigated drugs

68Ga-FAPI is a special type of imaging agent used in a PET scan to help doctors see certain types of cells in the body more clearly. In this trial, it is used to detect pancreatic cancer earlier by targeting a protein called the Fibroblast Activation Protein, which is often found in cancerous tissues. This helps doctors get a better picture of the cancer and understand how it might affect the patient's health in the future.

(S)-2,2',2''-(10-(2-(4-(3-((4-(2-(2-Cyano-4,4-Difluoropyrrolidin-1-Yl)-2-Oxoethylcarbamoyl)-Quinolin-6-Yl)(Methyl)Amino)-Propyl)Piperazin-1-Yl)-2-Oxoethyl)-68Ga-[1,4,7,10]-Tetraazacyclododecane-1,4,7-Triyl)Triacetate

What is already known about the treatment

Fibroblast Activation Protein Inhibitor (FAPI) – This medication is administered through an injection and is used in a special type of imaging test called Positron Emission Tomography (PET). It is currently being studied in clinical trials for its potential to help diagnose pancreatic cancer earlier. The main use of FAPI is to help doctors see pancreatic tumors more clearly in imaging tests, especially in cases where the cancer has not spread to other parts of the body. At the molecular level, FAPI works by targeting a specific protein found in cancer cells, which helps highlight these cells during imaging. It is classified as a diagnostic agent in the field of pharmacology.

Investigated diseases

Non-metastatic Pancreatic Ductal Adenocarcinoma – This is a type of cancer that originates in the ducts of the pancreas and has not spread to other parts of the body. It begins when cells in the pancreatic ducts grow uncontrollably, forming a tumor. As the disease progresses, the tumor can grow larger and may invade nearby tissues and organs. The growth of the tumor can lead to symptoms such as abdominal pain, weight loss, and jaundice. Over time, the cancer may obstruct the bile duct or digestive tract, causing further complications. The progression of the disease is typically monitored through imaging techniques like CT scans.