Recruiting

Study on Imaging Non-Small Cell Lung Cancer Using 68GaNOTA-Anti-MMR VHH2 in Patients

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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 non-small cell lung cancer (NSCLC), a common type of lung cancer. The study will use a special imaging agent called 68GaNOTA-Anti-MMR VHH2, which is a solution for injection. This agent is designed to help visualize certain cells in the body using a technique called Positron Emission Tomography (PET). PET is a type of imaging test that helps doctors see how tissues and organs are functioning.

The purpose of the study is to explore how well the imaging agent can highlight specific cells known as macrophages, which are a type of immune cell, in patients with NSCLC. The study will involve patients who are scheduled for surgery to remove or biopsy a lung tumor. Before the surgery, patients will receive an injection of the imaging agent, and a PET scan will be performed to see how much of the agent is taken up by the tumor. After the tumor is removed, it will be examined in the lab to compare the imaging results with the actual presence of macrophages in the tissue.

Participants in the study will receive the imaging agent through an injection into a vein, and the entire process will be closely monitored by medical professionals. The study aims to provide valuable information about the potential of this imaging agent to improve the understanding and treatment of NSCLC by offering a clearer picture of the disease at a cellular level.

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
Joining the study
Upon joining the study, you will be required to provide informed consent. This means you agree to participate after understanding the details and potential risks of the study.
You must be at least 18 years old and have a diagnosis of non-small cell lung cancer that is either local, locally advanced, or metastatic. You should be scheduled for a surgical procedure to remove or biopsy a tumor that meets specific size criteria.
Step 2
Preparation for imaging
Before the imaging procedure, you will receive an injection of a solution called 68Ga-UZBRU-VHH2. This is a special substance that helps to visualize certain cells in your body using a technique called Positron Emission Tomography (PET).
The injection is administered through a vein, a process known as intravenous administration.
Step 3
Imaging procedure
After the injection, you will undergo a PET scan. This imaging test allows doctors to see how the 68Ga-UZBRU-VHH2 is taken up by the cells in your body, particularly in the lung cancer lesion.
The goal is to assess the presence of specific cells in the tumor that express a marker called MMR.
Step 4
Surgical procedure
Following the imaging, you will proceed with the planned surgical procedure to remove or biopsy the tumor.
The tissue obtained from this procedure will be examined to determine the MMR score, which helps in understanding the characteristics of the tumor.
Step 5
Follow-up
After the surgery, there may be follow-up visits to monitor your recovery and gather additional information as needed for the study.
These visits are important to ensure your well-being and to collect data that contributes to the study's objectives.

Who can join the trial?

5 criteria

Patients with non-small cell lung cancer.
Patients who have given informed consent (this means you agree to participate after being told about the study).
Patients who are at least 18 years old.
Patients with local, locally advanced, or metastatic lung cancer who are planned for resection (surgical removal) or surgical biopsy (taking a small sample) of at least one lesion (area of cancer). The tumor should be at least 10 mm in size in certain dimensions.
Patients who have already participated in this study can join again if they meet all the inclusion criteria and none of the exclusion criteria at the time of the second inclusion.

Who cannot join the trial?

3 criteria

Patients who do not have non-small cell lung cancer.
Patients who are not within the specified age range for the study.
Patients who are part of a vulnerable population.

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Verified sites

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Vrije Universiteit Brussel
Jette, Belgium

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Investigated drugs

68GaNOTA-Anti-MMR VHH2 is a special type of imaging agent used in this clinical trial. It is designed to help doctors see certain cells in the body more clearly using a scan called Positron Emission Tomography, or PET. This agent targets specific cells known as MMR-expressing macrophages, which are a type of immune cell. By using this imaging agent, doctors hope to better understand how these cells are involved in non-small cell lung cancer, which can help in planning treatment and understanding the disease better.

Nanobody Against Macrophage Mannose Receptor, Conjugated With 1,4,7-Triazacyclononane-N,N',N''-Triacetic Acid, Labelled With Gallium Ga-68

What is already known about the treatment

68GaNOTA-Anti-MMR VHH2 – This medication is administered through an injection and is used for imaging purposes in patients with non-small cell lung cancer. It is currently being studied in clinical trials to assess its effectiveness in visualizing specific immune cells in the body using a technique called Positron Emission Tomography (PET). The main therapeutic indication is to help doctors see and understand the presence of certain immune cells in lung cancer tissues. At the molecular level, it works by binding to a protein on the surface of these immune cells, allowing them to be seen on PET scans. It is classified as a radiopharmaceutical, which means it is a type of drug that contains a radioactive substance used for diagnostic purposes.

Investigated diseases

Non-Small Cell Lung Cancer – Non-small cell lung cancer (NSCLC) is a type of lung cancer that includes several subtypes, such as adenocarcinoma, squamous cell carcinoma, and large cell carcinoma. It begins in the tissues of the lungs and is characterized by the uncontrolled growth of abnormal cells. As the disease progresses, these cancerous cells can form tumors and potentially spread to other parts of the body. NSCLC typically grows and spreads more slowly than small cell lung cancer. The progression of the disease can lead to symptoms such as persistent cough, chest pain, and difficulty breathing. Over time, the cancer may invade nearby tissues and organs, affecting their function.