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Testing F-18-AraG imaging scan reliability in patients with lung cancer using repeat scans

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 study involves people who have lung cancer. The research uses a special imaging tracer called [18F]F-AraG, which is a modified form of nelarabine that has been changed into a substance that can be detected by scanning equipment. This tracer is given through a vein and helps doctors see tumors and organs during imaging scans.

The purpose of this study is to measure how much the uptake of the tracer in tumors and organs varies between two scans that are done close together in time. During the study, participants will receive the tracer and undergo PET scans, which are special imaging tests that create pictures of the inside of the body. The scans will be repeated within a short time period to compare the results and see how consistent the imaging measurements are.

The study looks at whether the amount of tracer that appears in the tumor stays the same or changes between the two scans. This information helps researchers understand how reliable this imaging method is for looking at lung tumors. Participants must have at least one tumor that measures two centimeters or larger to be part of this research.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Confirmation of diagnosis and eligibility
Your lung cancer diagnosis will be confirmed through tissue examination.
At least one tumor in your body must measure 2 centimeters or larger.
Your disease will be assessed using a measurement system called RECIST 1.1, which is a standard way to measure tumors.
Step 2
First imaging scan
You will receive an imaging scan using a tracer called [18F]F-AraG.
This tracer is a radioactive substance that helps visualize tumors and organs on a PET scan, which is a type of imaging test that creates pictures of your body.
The tracer will be administered through a vein in your arm (intravenous administration).
The scan will measure how much of the tracer accumulates in your tumor and organs.
Step 3
Second imaging scan
You will receive a second [18F]F-AraG PET scan shortly after the first one.
The second scan will be performed in the same way as the first scan, with the tracer administered through a vein.
This repeat scan is done to compare the results and measure how consistent the imaging is between the two scans.
Step 4
Comparison of scan results
The two scans will be compared to measure differences in tracer uptake.
The measurements will include SUV (standardized uptake value), which indicates how much tracer is absorbed by the tumor, and TBR (tumor-to-background ratio), which compares the tumor uptake to surrounding tissue.
These measurements help determine the reliability of the imaging method.

Who can join the trial?

5 criteria

You must have lung cancer that has been confirmed by examining tissue samples under a microscope, which is called histologically confirmed
You must have at least one tumor that measures 2 centimeters or larger in size
You must be willing and able to sign a written document that shows you understand and agree to participate in the trial, which is called informed consent
You must be 18 years of age or older when you sign the consent form
You must have disease that can be measured using specific guidelines called RECIST 1.1, which is a standard way doctors measure tumors to track how they respond to treatment

Who cannot join the trial?

8 criteria

Pregnant women cannot participate in this study because the imaging test uses a radioactive substance that could harm the developing baby
Breastfeeding mothers are not allowed to join because the radioactive tracer used in the scan could pass into breast milk
People who have had a severe allergic reaction to the imaging agent or similar substances in the past cannot take part
Patients with uncontrolled diabetes, meaning their blood sugar levels are not well managed, are excluded because this can affect the scan results
People who cannot lie still for extended periods or have severe claustrophobia, which is an extreme fear of enclosed spaces, may not be able to participate since the scanning procedure requires staying still inside the imaging machine
Patients who have received another investigational drug, meaning an experimental medication being tested in research, within a certain time period before this study cannot join
People with conditions that prevent them from giving informed consent, meaning they cannot understand and agree to participate in the study on their own, are excluded
Patients with active infections or other serious medical conditions that could interfere with the study procedures or put them at risk are not eligible

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Verified sites

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Verified
Amsterdam UMC
Amsterdam, The Netherlands

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Investigated drugs

[18F]F-AraG is a radioactive tracer used in PET scans, which are special imaging tests that help doctors see inside your body. This tracer is designed to help doctors see and measure activity in lung tumors and organs. In this study, the tracer will be used twice in a short period of time to check how consistent the imaging results are when the scans are repeated.

Nelarabine

What is already known about the treatment

[18F]F-AraG – This is a radioactive imaging agent administered through injection into a vein, used in PET scans to visualize and measure activity in tumors and organs. It is currently being studied in clinical trials, particularly for evaluating lung cancer, and is not yet widely available as a standard treatment. The substance works by being taken up by activated immune cells, allowing doctors to see where the immune system is responding to cancer in the body. This medication belongs to the class of diagnostic radiopharmaceuticals, which are substances used to create images of what is happening inside the body at a cellular level.

Investigated diseases

Lung Cancer – Lung cancer is a disease where abnormal cells grow uncontrollably in the tissues of the lungs. These cells form masses called tumors that can interfere with normal lung function. As the disease progresses, the tumor may grow larger and spread to nearby tissues. The cancerous cells can also break away and travel through the bloodstream or lymphatic system to other parts of the body. This spreading process affects how well the lungs can take in oxygen and release carbon dioxide. The growth of these abnormal cells disrupts the normal structure and function of the lung tissue.