Recruiting

Study on [18F]FAPI-74 for Better Cancer Imaging in Patients with Esophagogastric and Pancreatic 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 studying different types of cancer, specifically oesophagogastric adenocarcinoma and pancreatic ductal adenocarcinoma. The study also includes patients with other challenging cancer situations. The trial will use a special imaging method called [18F]AlF-FAPI-74 PET/CT to help detect cancer cells. This imaging method involves a solution for injection that helps highlight cancer-associated fibroblasts, which are cells that can support cancer growth. The study aims to see if this new imaging method is better at detecting cancer than the current standard methods, such as [18F]FDG PET/CT or other conventional imaging techniques.

The trial will involve the use of two main treatments. The first is [18F]FAPI-74, a solution for injection that helps in imaging cancer cells. The second is Telebrix Gastro, a solution taken orally or rectally, which is used as a bowel opacifier to improve imaging results. The study will compare the effectiveness of these treatments in detecting cancer in newly diagnosed patients who have not yet received treatment. The goal is to determine if the new imaging method can provide better information about the cancer, which could help in planning the best treatment approach.

Participants in the study will undergo imaging tests using the new method, and the results will be compared to those from standard imaging techniques. The study will take place over a period of time, with the aim of gathering enough data to understand the benefits of the new imaging method. This research could potentially lead to improved ways of diagnosing and managing cancer, providing doctors with more accurate information to guide treatment decisions.

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 the diagnosis of oesophagogastric adenocarcinoma or pancreatic ductal adenocarcinoma, or other malignancies in a clinically challenging situation.
A [18F]FDG PET/CT scan is required, either already completed or planned within the next four weeks.
Step 2
Consent and documentation
Voluntary written informed consent is obtained from the participant or their legally authorized representative before any further procedures.
Step 3
Administration of imaging agent
The imaging agent [18F]AlF-FAPI-74 is administered through intravenous injection. This agent is used for PET/CT imaging to detect cancer-associated fibroblasts.
Step 4
Imaging procedure
A PET/CT scan is performed to evaluate the presence and extent of cancer. This scan aims to provide a superior detection ratio compared to conventional imaging methods.
Step 5
Evaluation of results
The results of the PET/CT scan are analyzed to determine the detection ratio for lymph node and distant metastases.
The scan results are used to assess whether the imaging agent can effectively identify malignant or non-malignant lesions.
Step 6
Follow-up and conclusion
The trial is expected to continue until October 2026, with ongoing assessments and follow-ups as needed.
The primary goal is to demonstrate the clinical utility of [18F]AlF-FAPI-74 PET/CT in detecting cancer-associated fibroblasts in various tumor types.

Who can join the trial?

11 criteria

The participant or their legally authorized representative must provide voluntary written informed consent before any screening procedures begin. This means they agree to take part in the study after understanding what it involves.
The participant must be **18 years old or older**.
For participants with **oesophagogastric adenocarcinoma (OGA)**:
- They must have a new diagnosis confirmed by a test that looks at cells or tissues under a microscope.
- They must have had a special type of scan called **[18F]FDG PET/CT** or be scheduled to have one within the next 4 weeks.
- Their cancer must be classified as **cT1-4N0-3M0** according to a system that describes the size and spread of cancer.
- For participants with **pancreatic ductal adenocarcinoma (PDAC)**:
  - They must have a new diagnosis confirmed by a test that looks at cells or tissues under a microscope.
  - They must have had a **[18F]FDG PET/CT** scan or be scheduled to have one within the next 4 weeks, or they must have had or be scheduled to have a conventional scan of the upper abdomen using **CT** or **MRI** within the next 4 weeks.
  - Their cancer must be classified as **cT1-4N0-2M0-1**, except for those whose cancer can be surgically removed right away.
  - For oncology patients in a clinically challenging situation:
    
    They must have a diagnosis of cancer confirmed by a test that looks at cells or tissues under a microscope.
    They must have had a **[18F]FDG PET/CT** scan or be scheduled to have one within the next 4 weeks.
    They must have unexplained symptoms, complaints, or unusual findings from tests or scans.

Who cannot join the trial?

6 criteria

Patients who have already received treatment for their cancer cannot participate. This means if you have started any cancer treatment, you are not eligible.
Patients with other serious health conditions that might interfere with the study are not eligible. This includes any major health issues that could affect the study results.
Pregnant or breastfeeding women cannot participate. This is to ensure the safety of both the mother and the baby.
Patients who are unable to give informed consent are not eligible. This means you must be able to understand the study and agree to participate.
Patients with allergies to the substances used in the study cannot participate. This is to prevent any allergic reactions during the study.
Patients who are part of another clinical trial at the same time are not eligible. This is to avoid any interference between different studies.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Katholieke Universiteit te Leuven
Responsive
Leuven, Belgium
Universitair Ziekenhuis Gent
Responsive
Gent, Belgium
University Of Antwerp
Verified
Edegem, Belgium

Trial locations

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Investigated drugs

[18F]AlF-FAPI-74
is a new imaging agent used in PET scans to detect cancer-associated fibroblasts. These fibroblasts are cells that play a role in the growth and spread of tumors. This agent helps doctors see these cells more clearly in different types of tumors, which can improve the diagnosis and treatment planning for cancer patients.
[18F]FDG
is a commonly used imaging agent in PET scans. It helps to identify areas of high glucose metabolism, which is often seen in cancer cells. This agent is used to compare the effectiveness of the new imaging agent, [18F]AlF-FAPI-74, in detecting cancerous tissues.

[Al[18F]F]Fapi-74

What is already known about the treatment

[18F]AlF-FAPI-74 – This medication is administered through a PET/CT scan, where it is used as a radiotracer to image cancer-associated fibroblasts in various tumor types. It is currently being studied in clinical trials to assess its effectiveness in detecting certain cancers, such as oesophagogastric adenocarcinoma and pancreatic ductal adenocarcinoma, compared to traditional imaging methods. The main therapeutic indication is to improve cancer detection in patients with challenging clinical situations. At the molecular level, it targets fibroblast activation protein, which is often overexpressed in cancer-associated fibroblasts, allowing for enhanced imaging of tumors. It falls under the pharmacological classification of radiopharmaceuticals used in diagnostic imaging.

Investigated diseases

Oesophagogastric adenocarcinoma
This is a type of cancer that occurs in the esophagus and stomach, specifically in the glandular cells that line these organs. It typically begins in the inner layer and can grow outward, potentially affecting nearby tissues and organs. As it progresses, it may spread to lymph nodes and other parts of the body. Symptoms can include difficulty swallowing, weight loss, and stomach pain. The disease is often diagnosed at an advanced stage due to its subtle early symptoms.
Pancreatic ductal adenocarcinoma
This is a common form of pancreatic cancer that originates in the ducts of the pancreas. It is characterized by the uncontrolled growth of cells in the pancreatic ducts, which can invade nearby tissues and organs. The disease often progresses silently, with symptoms like jaundice, abdominal pain, and weight loss appearing in later stages. It can spread to lymph nodes and distant organs, complicating its management. Early detection is challenging due to the deep location of the pancreas and the non-specific nature of initial symptoms.
Clinically challenging oncological situations
This term refers to complex cancer cases where standard diagnostic and treatment approaches may not be straightforward. These situations can involve unusual presentations, ambiguous imaging results, or cancers that do not respond predictably to typical therapies. The progression of such cases can vary widely, requiring personalized assessment and management. The complexity may arise from the cancer's location, its interaction with other medical conditions, or its atypical behavior. These cases often necessitate advanced imaging techniques and multidisciplinary collaboration to determine the best course of action.