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Study on [68Ga]Ga-FAPI-46 PET/CT Imaging for Better Diagnosis in Patients with Pancreatic and Gastroesophageal Cancer

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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 improving the way doctors diagnose and plan treatment for two types of cancer: pancreatic cancer and gastroesophageal cancer, which includes cancers of the esophagus, the junction between the esophagus and stomach, and the stomach itself. The study will use a special imaging technique called total body PET/CT with a tracer known as [68Ga]Ga-FAPI-46. A tracer is a substance that helps highlight certain areas in the body during imaging tests. This new method will be compared to standard imaging techniques to see if it provides better information for doctors.

The purpose of the study is to evaluate how well the [68Ga]Ga-FAPI-46 tracer works in detecting cancerous lesions, which are areas of abnormal tissue that may indicate cancer. Participants in the study will receive an injection of the tracer, and then undergo a PET/CT scan, which combines two types of imaging: positron emission tomography (PET) and computed tomography (CT). This scan will be done shortly after the injection to see how sensitive the tracer is in identifying cancerous areas compared to the usual imaging methods.

The study will help determine if using [68Ga]Ga-FAPI-46 can improve the accuracy of cancer diagnosis and assist in planning surgeries or other treatments. By comparing the new imaging method with current practices, researchers aim to find out if it can lead to better management of these cancers. The study will also look at how the tracer is taken up by cancerous lesions, which could provide additional insights into its effectiveness.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial visit and consent
Upon joining the study, the patient will attend an initial visit where detailed information about the trial will be provided. The patient will be required to read and understand the study details and provide informed consent to participate.
The patient must be able to read and understand the information in Danish to give informed consent.
Step 2
Eligibility confirmation
The patient's eligibility will be confirmed based on specific criteria. For group A, patients must be 18 years or older, have suspected pancreatic cancer, and be considered suitable for curative surgery.
For group B, patients must be 18 years or older, have a confirmed carcinoma from the lower esophagus, gastroesophageal junction, or stomach, and be considered operable and resectable.
Step 3
Preparation for imaging
The patient will be prepared for imaging procedures. This involves ensuring that the patient is ready for the administration of the imaging tracer [68Ga]Ga-FAPI-46.
Step 4
Tracer administration
The patient will receive an intravenous injection of the imaging tracer [68Ga]Ga-FAPI-46. This is a solution for injection administered through a vein.
Step 5
Imaging procedure
After the tracer injection, the patient will undergo a total body PET/CT scan. This imaging procedure will take place within 30 minutes of the tracer injection to evaluate the sensitivity of detecting cancerous lesions.
A second scan may be conducted 60 minutes after the tracer injection to further assess the accuracy and specificity of the imaging.
Step 6
Follow-up and results
The patient will have follow-up appointments to discuss the results of the imaging and any potential impact on their treatment plan.
The study aims to improve diagnostic sensitivity and preoperative staging for patients with gastroesophageal and pancreatic cancer.

Who can join the trial?

6 criteria

Must be a male or female who is 18 years or older.
For Group A: Must have suspected pancreatic cancer based on imaging tests like CT or MRI, with no signs of cancer spreading to other parts of the body.
For Group A: Must be considered suitable for curative surgery, meaning surgery that aims to remove all cancer.
For Group B: Must have a confirmed diagnosis of cancer in the lower esophagus, gastroesophageal junction (GEJ), or stomach.
For Group B: Must be considered operable and resectable, meaning the cancer can be removed by surgery.
Must be able to read and understand the patient information provided in Danish to give informed consent.

Who cannot join the trial?

3 criteria

Patients who do not have **pancreatic cancer** or **gastroesophageal cancer** (cancer of the esophagus, gastroesophageal junction, or stomach) cannot participate.
Patients who are not within the specified age range for the study cannot participate.
Patients who are part of a vulnerable population, which means they might need special protection or care, cannot participate.

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Verified sites

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Rigshospitalet
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Copenhagen, Denmark

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Investigated drugs

[68Ga]Ga-FAPI-46 is a special substance used in a type of medical imaging called PET/CT scans. This imaging helps doctors see inside the body to find cancer. In this study, the goal is to see if this substance can help doctors find cancer more accurately and quickly in patients with gastroesophageal and pancreatic cancer. The substance works by attaching to certain parts of cancer cells, making them visible on the scan. This can help doctors understand the extent of the cancer and plan the best treatment for the patient.

What is already known about the treatment

[68Ga]Ga-FAPI-46 – This medication is administered through an injection and is used in a special type of imaging test called PET/CT, which helps doctors see inside the body. It is currently being studied for its effectiveness in diagnosing and staging cancers of the pancreas and the gastroesophageal region, which includes the esophagus and stomach. The main purpose of this medication is to improve the accuracy of cancer detection compared to standard imaging methods. At the molecular level, it works by targeting a specific protein found in cancer cells, allowing doctors to see these cells more clearly on the scan. It is classified as a radiopharmaceutical, which means it is a radioactive substance used for medical 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 ducts that carry pancreatic juices. As the disease progresses, it can invade nearby organs and spread to other parts of the body. Symptoms may include jaundice, weight loss, and abdominal pain. The progression can be slow or rapid, depending on the type and location of the cancer within the pancreas. It is often diagnosed at an advanced stage due to its subtle early symptoms.
Gastroesophageal Cancer
Gastroesophageal cancer refers to malignancies that occur in the esophagus, gastroesophageal junction, or stomach. It typically begins in the cells lining these organs and can grow to invade deeper layers and nearby structures. As the disease advances, it may spread to lymph nodes and distant organs. Symptoms can include difficulty swallowing, chest pain, and unintentional weight loss. The progression of the disease can vary, with some types growing more aggressively than others. Early stages may not present noticeable symptoms, leading to later-stage diagnoses.