Not recruiting

Study on 68Ga-FAPI-46 and Fludeoxyglucose (18F) for Diagnosing Stomach and Gastroesophageal Junction Cancer in Patients Undergoing Chemotherapy

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 studying two types of cancer: gastric cancer and gastroesophageal junction cancer. The study aims to evaluate the effectiveness of a new imaging method using a substance called 68Ga-FAPI-46 compared to the standard imaging method using Fluor-18-FDG. Both substances are injected into the body and help doctors see the cancer more clearly using a special type of scan called PET/CT, which combines positron emission tomography and computed tomography to create detailed images of the inside of the body.

The purpose of the study is to compare how well these two imaging methods work in detecting cancer at different stages, both before and after chemotherapy treatment. Participants will undergo scans using both 68Ga-FAPI-46 and Fluor-18-FDG to see which method provides more accurate information about the cancer's location and size. This will help doctors determine the best way to stage the cancer, which means understanding how far it has spread, and to plan the most effective treatment.

Throughout the study, researchers will also explore how feasible it is to use 68Ga-FAPI-46 in routine practice and identify any potential limitations of this new imaging method. The study will involve several visits for scans and assessments, but it does not require any surgical procedures. The information gathered from this trial could lead to improved imaging techniques for patients with gastric and gastroesophageal junction cancer, potentially leading to better treatment outcomes.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, eligibility is confirmed based on specific criteria, including a diagnosis of gastric or gastroesophageal junction cancer.
Participants must be 18 years or older and able to provide consent.
Step 2
Initial assessment
An initial assessment is conducted to establish a baseline for the study. This includes a FDG PET/CT scan, which uses a radioactive sugar solution to highlight areas of cancer in the body.
Step 3
First imaging session
Participants undergo a 68Ga-FAPI PET/CT scan. This involves the injection of a solution called 68Ga-FAPI-46 through an intravenous infusion.
The scan helps to visualize cancerous tissues by targeting specific proteins in the body.
Step 4
Neoadjuvant chemotherapy
Participants may receive chemotherapy treatment aimed at reducing the size of the tumor before surgery. This phase is known as neoadjuvant chemotherapy.
Step 5
Restaging imaging session
After chemotherapy, a second 68Ga-FAPI PET/CT scan is performed to assess changes in the cancer.
This scan is compared to the initial scan to evaluate the effectiveness of the chemotherapy.
Step 6
Data analysis
The results from the FAPI PET/CT and FDG PET/CT scans are analyzed to determine the accuracy of the imaging techniques in detecting cancer.
The study aims to compare the findings from both types of scans to a standard reference.
Step 7
Follow-up
Participants may be monitored for any changes in their condition and to assess the long-term outcomes of the imaging techniques used in the study.

Who can join the trial?

6 criteria

Must have a new diagnosis of **gastric cancer** or **gastroesophageal junction cancer** (GEJ cancer) confirmed by a biopsy, which is a small sample of tissue taken from the body to check for disease.
Must be referred for a primary staging **FDG PET/CT** scan, which is a type of imaging test that helps doctors see how the cancer is affecting the body.
Must be considered suitable for surgery and able to have the tumor removed, with or without having had **neoadjuvant chemotherapy**, which is treatment given before the main treatment to shrink a tumor.
Must be physically and mentally capable of participating in the research study.
Must be able to read and understand Danish.
Must be 18 years or older and able to give consent to participate in the study.

Who cannot join the trial?

4 criteria

Patients with any other type of cancer besides Gastroesophageal junction cancer or Gastric cancer 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.
Patients who do not meet the specific health requirements set by the study cannot participate.

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Verified sites

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Aalborg University Hospital
Aalborg, Denmark

Trial locations

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Investigated drugs

68Ga-FAPI PET/CT
This is a type of imaging test used to help diagnose and stage cancer. It involves a special radioactive substance called 68Ga-FAPI, which is injected into the body. This substance helps highlight cancer cells during a PET/CT scan, making it easier for doctors to see where the cancer is located and how much it has spread. This test is being studied for its accuracy in detecting cancer in patients with gastric and gastro-esophageal junctional cancer, both at the initial diagnosis and after chemotherapy treatment.
FDG PET/CT
This is another imaging test that uses a different radioactive substance called FDG to detect cancer. Like the 68Ga-FAPI PET/CT, it helps doctors see cancer cells in the body during a PET/CT scan. This test is commonly used to stage cancer and check how well the treatment is working. In this trial, it is being compared to the 68Ga-FAPI PET/CT to see which test provides more accurate information about the cancer.

What is already known about the treatment

68Ga-FAPI – This medication is administered through an intravenous injection and is used in conjunction with PET/CT scans. It is currently being studied for its effectiveness in diagnosing and staging gastric cancer and gastroesophageal junction cancer. The main therapeutic indication is to improve the accuracy of cancer staging and restaging, particularly after chemotherapy. At the molecular level, 68Ga-FAPI targets fibroblast activation protein, which is often overexpressed in cancerous tissues, allowing for better imaging of tumors. It falls under the pharmacological classification of radiopharmaceuticals used in diagnostic imaging.

Investigated diseases

Gastroesophageal Junction Cancer
This type of cancer occurs where the esophagus meets the stomach. It often begins in the cells lining the inside of this area and can spread to nearby tissues. As it progresses, it may invade deeper layers of the esophagus and stomach, potentially affecting nearby lymph nodes. Symptoms can include difficulty swallowing, chest pain, and weight loss. The disease may advance to involve distant organs if not managed. It is often associated with risk factors such as gastroesophageal reflux disease and obesity.
Gastric Cancer
Also known as stomach cancer, this disease originates in the stomach lining. It typically begins in the mucus-producing cells and can grow to invade deeper layers of the stomach wall. As it progresses, it may spread to nearby lymph nodes and other organs such as the liver and lungs. Symptoms can include indigestion, stomach pain, nausea, and loss of appetite. The disease can develop over many years and is often linked to factors like infection with Helicobacter pylori and certain dietary habits.