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Study on the Effectiveness of [18F]FAPI-74 PET/CT for Detecting Lymph Node Spread in Patients with 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 pancreatic cancer, a disease where cells in the pancreas grow uncontrollably. The trial will use a special imaging technique called 18F-FAPI-74 PET/CT. This method involves a solution for injection that helps doctors see the cancer more clearly in scans. The purpose of the study is to determine how accurately this imaging technique can detect cancer that has spread to nearby lymph nodes in patients with pancreatic cancer.

Participants in the study will receive an injection of the 18F-FAPI-74 solution, which is a chemical substance designed to highlight cancerous areas during a scan. The scan, known as a PET/CT, combines two types of imaging to provide detailed pictures of the inside of the body. This helps doctors identify if the cancer has spread to lymph nodes, which are small glands that are part of the immune system.

The study will follow patients who have either primary or recurrent pancreatic cancer. It aims to see if the 18F-FAPI-74 PET/CT scan can detect cancer spread with at least 70% accuracy. This research could improve how doctors diagnose and treat pancreatic cancer by providing more precise information about the disease's progression.

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 assessment
Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying the presence of primary or recurrent pancreatic cancer and ensuring the individual is between 18 and 85 years old with a WHO performance score of 0-2.
Step 2
Informed consent
The individual is provided with written information about the study. After reviewing this information, the individual signs an informed consent form to participate in the trial.
Step 3
Administration of <b>[18F]FAPI-74</b>
The individual receives an intravenous bolus injection or IV infusion of [18F]FAPI-74, which is a solution for injection. This step is crucial for the subsequent imaging process.
Step 4
PET/CT scan
A PET/CT scan is performed to assess the accuracy of [18F]FAPI-74 in detecting local lymph node metastasis. This imaging process helps in evaluating the spread of cancer at the patient level.
Step 5
Follow-up and results
The results of the PET/CT scan are analyzed to determine the sensitivity of [18F]FAPI-74 in detecting metastatic lymph nodes. The primary endpoint is to achieve a 70% sensitivity rate.

Who can join the trial?

5 criteria

The patient must have either a new or returning case of pancreatic cancer.
The patient may also be suspected of having a new or returning case of pancreatic cancer.
The patient can be either male or female and must be between the ages of 18 and 85 years old.
The patient must have a WHO performance score between 0 and 2. This score is a way to measure how well a patient can perform daily activities. A score of 0 means fully active, while 2 means the patient is up and about more than half the day but may not be able to work.
The patient must agree to participate by signing a consent form after being given written information about the study.

Who cannot join the trial?

3 criteria

Patients who do not have primary pancreatic cancer cannot participate. This means the study is only for those who have been diagnosed with pancreatic cancer that has not spread from another part of the body.
Patients who are not within the specified age range cannot participate. The study is for adults, so children and teenagers are excluded.
Patients who are part of a vulnerable population cannot participate. This means people who might need special protection or care, like those with certain disabilities or who are unable to make decisions for themselves, are not included.

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Verified sites

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Turku University Hospital
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Turku, Finland

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Investigated drugs

18F-FAPI-74 is a special imaging agent used in PET/CT scans. It helps doctors see if pancreatic cancer has spread to nearby lymph nodes. This medication is injected into the body, and it lights up areas where cancer might be present, making it easier for doctors to diagnose and plan treatment.

[Al[18F]F]Fapi-74

What is already known about the treatment

18F-FAPI-74 – This medication is administered through an intravenous injection and is used in combination with PET/CT imaging. It is currently being studied in clinical trials for its effectiveness in diagnosing pancreatic cancer, particularly in detecting local lymph node metastasis. The main therapeutic indication is for diagnostic imaging in patients with pancreatic cancer. At the molecular level, 18F-FAPI-74 targets fibroblast activation protein, which is often overexpressed in cancerous tissues, allowing for enhanced imaging contrast. It is classified as a radiopharmaceutical used in diagnostic imaging.

Investigated diseases

Pancreatic cancer – Pancreatic cancer is a disease where malignant cells form in the tissues of the pancreas, an organ located behind the stomach that helps with digestion and blood sugar regulation. It often begins in the cells that produce digestive juices or hormones. As the cancer progresses, it can invade nearby organs and spread to other parts of the body. Symptoms may include jaundice, weight loss, and abdominal pain, but they often appear only in advanced stages. The disease can grow and spread quickly, making early detection challenging. It is typically diagnosed at a later stage due to its subtle early symptoms.