Not recruiting

Study of 68Ga Satoreotide Trizoxetan PET/CT in Patients with High-Grade Neuroendocrine Lung Cancer

Verified siteInvestigationalNo 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 a type of lung cancer known as high-grade neuroendocrine lung cancer, which includes large cell neuroendocrine lung cancer and small cell lung cancer. The study is investigating a new imaging method using a special tracer called 68Ga-satoreotide trizoxetan. This tracer is used in a type of scan called positron emission tomography or PET scan, which helps doctors see how the cancer is behaving inside the body.

The purpose of the study is to see how well the 68Ga-satoreotide trizoxetan tracer is taken up by cancer cells in patients with these types of lung cancer. During the study, patients will receive an injection of the tracer, and then undergo a PET/CT scan. This scan combines the PET scan with a computed tomography or CT scan, providing detailed images of the cancer. The study will compare these images to previous scans to see if the new tracer can identify cancerous areas more effectively.

The study will also measure certain parameters in the cancerous areas, such as how much of the tracer is absorbed, and compare these measurements to those in normal organs like the lung, kidney, and liver. This will help researchers understand how well the tracer can distinguish between cancerous and non-cancerous tissues. The study is expected to continue until mid-2026.

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, confirmation of eligibility is required. This includes having a pathologically verified diagnosis of either large cell neuroendocrine lung cancer or small cell lung cancer, being at least 18 years old, and providing informed oral and written consent.
Step 2
Initial assessment
An initial assessment is conducted to gather baseline information. This may involve reviewing previous medical records, including CT scans and any available PET/CT scans.
Step 3
Administration of tracer
The study involves the use of a new imaging tracer called 68Ga-satoreotide trizoxetan. This tracer is administered as a solution for injection. The injection is given to help visualize cancerous lesions during imaging.
Step 4
PET/CT scan
After the injection of the tracer, a PET/CT scan is performed. This scan helps in identifying any malignant lesions in the body. The scan results are compared with previous imaging to evaluate the effectiveness of the tracer.
Step 5
Follow-up and analysis
The results from the PET/CT scan are analyzed to determine the number and location of lesions. Measurements such as SUVmax, SUVpeak, and SUVmean are taken to assess the tracer uptake in both the lesions and background organs like the lung, kidney, spleen, liver, lymph nodes, and brain.
The study aims to estimate the tumor-to-background ratio by comparing the tracer uptake in malignant lesions with that in background organs.

Who can join the trial?

3 criteria

Must have a pathologically verified diagnosis of either small cell lung cancer (SCLC) or large cell neuroendocrine lung cancer (LCNEC). This means a doctor has confirmed the type of lung cancer through medical tests.
Must be 18 years of age or older.
Must provide informed consent, which means you agree to participate in the study after being fully informed about it. This consent must be given both orally (spoken) and in writing.

Who cannot join the trial?

3 criteria

Patients with any other type of cancer besides large cell neuroendocrine lung cancer or small cell lung cancer cannot participate.
Patients who are not within the specified age range cannot participate. The age range is typically defined in the study details.
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
Verified
Copenhagen, Denmark

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Investigated drugs

68Ga-satoreotide trizoxetan is a new type of imaging agent used in a special scan called a PET/CT scan. This medication helps doctors see certain types of cancer cells in the body more clearly. In this study, it is used to help find and understand high-grade neuroendocrine lung cancer. The medication is injected into the body, and then it travels to the cancer cells, making them light up on the scan. This helps doctors see where the cancer is located and how much of it is present, which can be very helpful in planning treatment.

Satoreotide Trizoxetan Gallium Ga-68

What is already known about the treatment

68Ga-satoreotide trizoxetan – This medication is administered through an injection and is used in a PET/CT scan to help visualize certain types of lung cancer. It is currently being studied in clinical trials to determine its effectiveness in detecting high-grade neuroendocrine lung cancers, such as large cell neuroendocrine lung cancer and small cell lung cancer. The main therapeutic use of this medication is to improve the imaging of these cancers, which can help doctors in diagnosing and planning treatment. At the molecular level, 68Ga-satoreotide trizoxetan works by binding to specific receptors on cancer cells, allowing them to be seen more clearly on imaging scans. It is classified as a radiopharmaceutical, which means it is a radioactive compound used for diagnosis or treatment in medicine.

Investigated diseases

Large Cell Neuroendocrine Lung Cancer
Large cell neuroendocrine lung cancer is a type of lung cancer characterized by large, abnormal cells that originate from neuroendocrine cells in the lungs. It is considered a high-grade tumor, meaning it tends to grow and spread more quickly than low-grade tumors. The disease often begins in the central part of the lungs and can invade nearby tissues or spread to other parts of the body. As it progresses, patients may experience symptoms such as cough, chest pain, and difficulty breathing. The aggressive nature of this cancer often leads to rapid changes in health status.
Small Cell Lung Cancer
Small cell lung cancer is a fast-growing type of lung cancer that primarily arises in the bronchi, the main airways of the lungs. It is characterized by small, round cancer cells that multiply quickly and form large tumors. This type of cancer often spreads early to other parts of the body, including the lymph nodes, liver, bones, and brain. Symptoms may include persistent cough, chest pain, shortness of breath, and weight loss. Due to its rapid progression, small cell lung cancer can lead to significant health changes in a short period.