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Study on the Use of 68Ga-EVG321 for Diagnosing Small Cell Lung Cancer in Patients

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 Small Cell Lung Cancer (SCLC), a type of lung cancer known for its rapid growth and spread. The study will use a special diagnostic treatment called 68Ga-EVG321, which is administered through an injection. This treatment involves a combination of two substances: Gallium (68Ga), a radioactive chemical, and EVG321, a protein-based compound. The purpose of the study is to understand how this treatment spreads throughout the body and to gather information on its safety and effectiveness in detecting SCLC.

Participants in the study will receive an intravenous injection of 68Ga-EVG321. After the injection, they will undergo imaging tests, such as PET/CT scans, to observe how the treatment moves and accumulates in different parts of the body, particularly in areas affected by cancer. These tests will help researchers measure the radioactivity levels in various organs and tissues over time. The study will also monitor participants for any side effects or changes in health indicators, such as lab test results, heart function, and vital signs.

The trial aims to compare the imaging results with traditional methods of diagnosing SCLC to see if 68Ga-EVG321 can provide more accurate information about the presence of cancer. By doing so, the study hopes to improve the understanding of how this diagnostic tool can be used in the future to help detect and manage Small Cell Lung Cancer more effectively.

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
Initial visit
Upon joining the study, you will attend an initial visit. During this visit, you will be asked to sign an informed consent form, which confirms your understanding and agreement to participate in the study.
You will undergo a series of assessments to confirm your eligibility, including a review of your medical history and a physical examination. If you are a woman of childbearing potential, a pregnancy test will be conducted.
Step 2
Administration of 68Ga-EVG321
You will receive an injection of the study medication, 68Ga-EVG321, through an intravenous injection. This means the medication will be administered directly into your vein.
The purpose of this medication is to help visualize certain areas of your body during imaging tests.
Step 3
Imaging tests
After receiving the injection, you will undergo a series of imaging tests, such as PET/CT scans. These tests will help assess the distribution of the medication in your body.
The scans will be performed at several time points to gather detailed information about how the medication is distributed in your body.
Step 4
Follow-up assessments
Throughout the study, you will have regular follow-up assessments to monitor your health and any potential side effects.
These assessments may include blood tests, ECGs (which are tests that measure the electrical activity of your heart), and checks of your vital signs, such as blood pressure and heart rate.
Step 5
End of study
At the end of the study, you will have a final visit to assess your overall health and review any findings from the study.
You will be informed about the next steps, if any, and any additional follow-up that may be required.

Who can join the trial?

7 criteria

Signed and dated ICF (Informed Consent Form) before any study-related procedure.
Male or female participants aged 18 years and older at the time of signing the ICF.
ECOG performance status of 0, 1, or 2. (This is a scale used to assess how a disease affects a patient's daily living abilities. 0 means fully active, and 2 means capable of all self-care but unable to carry out any work activities.)
Participants with histologically or cytologically confirmed small cell lung cancer (SCLC). (This means the cancer has been confirmed by examining cells or tissues under a microscope.)
Participants with evaluable ex-vivo tumor tissue. (This means there is tumor tissue available outside the body that can be evaluated.)
Participants of childbearing potential must have a negative urine or blood pregnancy test. If they are sexually active, they must use a highly effective method of contraception from the first visit until at least 14 days after stopping the study treatment. Acceptable methods include non-hormonal contraception, sexual abstinence, or having a partner who has had a vasectomy (a procedure to prevent sperm from being released).
Male participants who are sexually active with a partner of childbearing potential must agree to use a male condom from the day of receiving the study treatment until at least 14 days after. They must also agree not to donate semen during the study and for 14 days after the study ends. Alternatively, they must have documented permanent sterilization by vasectomy.

Who cannot join the trial?

3 criteria

Patients who do not have a confirmed diagnosis of Small Cell Lung Cancer 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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Azienda Ospedaliera Papa Giovanni XXIII
Bergamo, Italy
Verified
Klinikum der Technischen Universitaet Muenchen (TUM Klinikum)
Munich, Germany
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Medizinische Universitaet Innsbruck
Innsbruck, Austria

Trial locations

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Investigated drugs

68Ga-EVG321 is a special type of imaging agent used in this clinical trial. It is designed to help doctors see inside the body using a type of scan called a PET scan. This medication is particularly used to look at small cell lung cancer. When injected into the body, it travels to specific areas, allowing doctors to see how the cancer is distributed throughout the body. This helps in understanding how the cancer is behaving and can assist in planning further treatment.

What is already known about the treatment

68Ga-EVG321 – This medication is administered as an injection and is used in diagnostic imaging for patients with small cell lung cancer (SCLC). It is currently being studied in clinical trials to understand how it spreads throughout the body and how much radiation it delivers to different tissues. The main purpose of 68Ga-EVG321 is to help visualize cancerous tissues in the body, aiding in the diagnosis and management of SCLC. It works by binding to specific targets in the cancer cells, allowing them to be seen more clearly on imaging scans. This medication is classified as a radiopharmaceutical, which means it is a radioactive compound used for medical imaging.

Investigated diseases

Small Cell Lung Cancer – Small Cell Lung Cancer is a type of lung cancer characterized by small cells that multiply quickly and form large tumors. It typically begins in the bronchi, which are the main airways of the lungs, and can spread rapidly to other parts of the body, including the lymph nodes, liver, bones, adrenal glands, and brain. The disease progresses in two main stages: limited stage, where cancer is confined to one lung and possibly nearby lymph nodes, and extensive stage, where it has spread beyond the lung to other parts of the body. Small Cell Lung Cancer is known for its aggressive nature and rapid growth, often leading to early metastasis. The cancer cells in this type are smaller than normal cells and have a high nucleus-to-cytoplasm ratio. It is strongly associated with smoking, and symptoms may include coughing, chest pain, and difficulty breathing.