Not recruiting

Study on [68Ga]Ga-FAPI-46 and Iodixanol for Better Imaging in Patients with Pancreatic and Gastroesophageal Cancer

Verified siteRegistered drugNo 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 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 study aims to see if this new method can provide better images than the standard imaging techniques currently used.

Participants in the study will receive an injection of the tracer [68Ga]Ga-FAPI-46, which will help doctors see the cancer more clearly during the PET/CT scan. The study will compare these images to those obtained from standard imaging methods like CT or MRI. Another substance, iodixanol, which is a type of contrast used in imaging, may also be used to help improve the clarity of the images. The goal is to determine if the new imaging method can detect cancer more accurately and help in planning the best treatment approach.

The study will take place over a period of time, with participants undergoing the imaging process and then being monitored to see how the new imaging method affects their treatment plan. The researchers hope that this new approach will lead to better outcomes for patients by providing more detailed information about the cancer, which can help in making more informed decisions about surgery and other treatments.

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 assessment
Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes reviewing medical history and current health status.
Eligibility criteria include being 18 years or older, having a diagnosis of pancreatic or gastroesophageal cancer, and being able to read and understand the patient information in Danish.
Step 2
Preparation for imaging
Before the imaging procedure, preparation involves understanding the process and what to expect during the scan.
The imaging procedure uses a tracer called [68Ga]Ga-FAPI-46, which is administered through an intravenous injection.
Step 3
Imaging procedure
The imaging procedure involves a total body positron emission tomography (PET) and computed tomography (CT) scan.
The [68Ga]Ga-FAPI-46 tracer is injected, and the scan is performed within 30 minutes to evaluate the sensitivity of detecting cancerous lesions.
Step 4
Follow-up imaging
A follow-up scan may be conducted 60 minutes after the initial injection to further assess the accuracy and specificity of the imaging results.
This step helps in understanding the uptake of the tracer in suspicious lesions.
Step 5
Evaluation of results
The results from the imaging are evaluated to determine the sensitivity and potential impact on patient management.
This evaluation helps in comparing the new imaging method with standard imaging techniques like CT, MRI, or [18F]FDG PET/CT.
Step 6
End of trial participation
Participation in the trial concludes after the final evaluation of imaging results.
The study aims to improve diagnostic sensitivity and preoperative staging in patients with pancreatic and gastroesophageal cancer.

Who can join the trial?

11 criteria

Must be a male or female who is 18 years old or older.
For Group A: Must have suspected pancreatic cancer based on findings from standard imaging tests.
For Group A: Must have had a CT, MRI, or PET/CT scan showing no initial signs of cancer spreading to distant parts of the body.
For Group A: Must be considered suitable for surgery aimed at curing the cancer at the time of referral.
For Group A: Must be able to read and understand the patient information in Danish to give informed consent.
For Group B1: Must have a confirmed diagnosis of carcinoma (a type of cancer) from the lower esophagus, gastroesophageal junction (GEJ), or stomach.
For Group B1: Must be considered operable and resectable, meaning the cancer can be surgically removed, at the time of referral.
For Group B1: Must be able to read and understand the patient information in Danish to give informed consent.
For Group B2: Must have a confirmed diagnosis of SRCC (signet ring cell carcinoma) or PCC (poorly cohesive carcinoma) from the lower esophagus, GEJ, or stomach.
For Group B2: Must have localized disease and be assigned to chemotherapy before surgery, or have metastatic disease and be assigned to treatment aimed at relieving symptoms.
For Group B2: Must be able to read and understand the patient information 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 belong to 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
Verified
Copenhagen, Denmark

Trial locations

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Investigated drugs

[68Ga]Ga-FAPI-46 is a tracer used in total body PET/CT scans. It helps doctors see cancer more clearly in patients with gastroesophageal and pancreatic cancer. This tracer is being studied to see if it can improve the accuracy of cancer diagnosis and help in planning surgery by providing better images than standard imaging methods.

What is already known about the treatment

[68Ga]Ga-FAPI-46 – This medication is administered through an injection and is used in total body PET/CT scans. It is currently being studied for its effectiveness in diagnosing gastroesophageal and pancreatic cancers. The main therapeutic indication is to improve diagnostic sensitivity and preoperative staging in these cancers. At the molecular level, it works by targeting fibroblast activation protein, which is often overexpressed in cancerous tissues, allowing for better imaging. It is classified as a radiopharmaceutical used in diagnostic imaging.

Investigated diseases

Pancreatic Cancer
This is a type of cancer that begins in the tissues of the pancreas, an organ located behind the lower part of the stomach. It often progresses silently, with symptoms appearing only in advanced stages. As the disease advances, it may cause abdominal pain, weight loss, and jaundice. The cancer can spread to nearby organs and blood vessels, complicating its progression. It is known for its aggressive nature and tendency to metastasize early.
Gastroesophageal Cancer
This term encompasses cancers of the esophagus, gastroesophageal junction, and stomach. It typically begins in the cells lining these areas and can progress to invade deeper layers and nearby structures. Symptoms may include difficulty swallowing, chest pain, and unintentional weight loss. As the disease progresses, it can spread to lymph nodes and distant organs. The progression can vary depending on the specific location and type of cancer cells involved.