Recruiting

Study on Changes in [18F]F-AraG Uptake After Radiotherapy in Patients with Non-Small Cell Lung Cancer, Melanoma, Breast Cancer, and Esophageal 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 the effects of a treatment in patients with certain types of cancer, including Melanoma, Breast Cancer, Non-small Cell Lung Cancer, and Esophageal Cancer. The treatment involves the use of a special imaging agent called [18F]F-AraG, which is a modified form of a drug known as Nelarabine. This agent is used to observe changes in cancer cells after they have been treated with radiotherapy, a type of treatment that uses high-energy rays to kill cancer cells.

The purpose of the study is to understand how the uptake of [18F]F-AraG changes in tumor lesions after radiotherapy. This will help researchers learn more about how cancer cells respond to treatment. Participants in the study will receive radiotherapy and will undergo imaging scans to track the uptake of the imaging agent in their tumors. These scans will be done at different times to see how the uptake changes over time.

Throughout the study, participants will continue their ongoing treatment with immunotherapy, which is a type of cancer treatment that helps the immune system fight cancer. The study aims to provide valuable insights into the effectiveness of radiotherapy in combination with immunotherapy by using the [18F]F-AraG imaging agent to monitor changes in the cancer cells. This research could lead to better understanding and improvements in cancer treatment strategies.

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
Joining the study
Upon joining the study, eligibility is confirmed based on specific criteria, including a diagnosis of non-small cell lung cancer, melanoma, esophageal, or breast cancer. Participation requires ongoing immunotherapy with an anti-PD-(L)1 agent and a plan for high-dose radiotherapy.
Written informed consent is required, and participants must be 18 years or older with a performance status of 0-2 on the ECOG Performance Scale.
Step 2
Initial imaging and treatment
The study involves imaging to assess the uptake of [18F]F-AraG in tumor lesions. This imaging is done before starting radiotherapy.
Participants receive high-dose radiotherapy, specifically 24Gy, as part of their treatment plan.
Step 3
Follow-up imaging
After radiotherapy, follow-up imaging is conducted to measure changes in [18F]F-AraG uptake in tumor lesions and lymphoid organs.
This imaging occurs at two intervals: one week and three weeks after completing radiotherapy.
Step 4
Assessment of results
The primary goal is to assess the change in [18F]F-AraG uptake in tumor lesions during anti-PD-1 treatment.
The study aims to define tracer uptake using specific parameters and to evaluate changes from baseline through the follow-up periods.

Who can join the trial?

6 criteria

You must have a confirmed diagnosis of one of the following cancers: Non-small Cell Lung Cancer (NSCLC), melanoma, esophageal cancer, or breast cancer. This means a doctor has checked your tissue under a microscope to confirm the type of cancer.
You must be currently receiving immunotherapy with a medicine called an anti-PD-(L)1 agent. Immunotherapy is a treatment that helps your immune system fight cancer.
You must be scheduled to receive a high dose of radiotherapy (24Gy) as part of your treatment plan. Radiotherapy uses high-energy rays to kill cancer cells.
You must be willing and able to sign a document called informed consent, which explains the details of the trial and confirms your agreement to participate.
You must have a performance status of 0-2 on the ECOG Performance Scale. This scale measures how well you can carry out daily activities. A score of 0 means you are fully active, while a score of 2 means you are up and about more than half the day but may not be able to work.
You must be over 18 years old on the day you sign the informed consent.

Who cannot join the trial?

8 criteria

Patients who are pregnant or breastfeeding cannot participate.
Individuals with a history of severe allergic reactions to similar drugs or treatments are excluded.
Patients with uncontrolled medical conditions, meaning their health issues are not well-managed, are not eligible.
People who have participated in another clinical trial within the last 30 days cannot join this study.
Individuals with a known infection, such as a virus or bacteria, that is not treated or controlled are excluded.
Patients with a history of another type of cancer, other than the ones being studied, in the last 5 years are not eligible.
Individuals with a mental health condition that might affect their ability to follow the study instructions are excluded.
Patients who are unable to provide informed consent, meaning they cannot fully understand and agree to the study, cannot participate.

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Amsterdam UMC
Amsterdam, The Netherlands

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Investigated drugs

[18F]F-AraG
is a special imaging agent used in this study to help visualize changes in tumor cells. It is used to see how the tumor in the lungs takes up this agent before and after receiving radiotherapy. This helps doctors understand how the cancer is responding to the treatment.
Radiotherapy
is a treatment that uses high doses of radiation to kill cancer cells and shrink tumors. In this trial, it is used to treat non-small cell lung cancer, and the study aims to observe how the cancer cells change after receiving this therapy.

Nelarabine

What is already known about the treatment

[18F]F-AraG – This medication is administered as an injectable radiotracer used in imaging studies. It is currently being investigated in clinical trials to assess its uptake in tumor lesions, particularly in conditions like melanoma, breast cancer, non-small cell lung cancer, and esophageal cancer. The main therapeutic indication is to evaluate changes in tumor activity following radiotherapy. At the molecular level, [18F]F-AraG works by targeting specific cellular processes within cancer cells, allowing for detailed imaging of tumor response. It is classified as a radiopharmaceutical used in diagnostic imaging.

Investigated diseases

Melanoma
Melanoma is a type of skin cancer that develops from the pigment-producing cells known as melanocytes. It often appears as a new mole or a change in an existing mole, with irregular shapes and multiple colors. Melanoma can occur anywhere on the body, but it is more common in areas exposed to the sun. As it progresses, melanoma can grow deeper into the skin and spread to other parts of the body. Early stages may be confined to the skin, but advanced stages can involve lymph nodes and internal organs. The progression of melanoma is influenced by factors such as genetic predisposition and UV exposure.
Breast Cancer
Breast cancer is a disease where cells in the breast grow uncontrollably, forming a tumor. It can begin in different parts of the breast, most commonly in the ducts or lobules. As the cancer progresses, it may spread to nearby lymph nodes and other parts of the body. Symptoms can include a lump in the breast, changes in breast shape, or skin dimpling. The progression of breast cancer varies depending on the type and stage at diagnosis. Hormonal, lifestyle, and environmental factors can influence its development.
Non-small Cell Lung Cancer
Non-small cell lung cancer (NSCLC) is the most common type of lung cancer, accounting for about 85% of cases. It typically starts in the epithelial cells lining the lungs and can grow slowly or rapidly, depending on the subtype. As NSCLC progresses, it can invade nearby tissues and spread to other parts of the body, such as the brain or bones. Symptoms may include a persistent cough, chest pain, and shortness of breath. The progression of NSCLC is influenced by factors like smoking history and genetic mutations. Early detection is crucial for managing its spread.
Esophageal Cancer
Esophageal cancer occurs in the esophagus, the tube that carries food from the throat to the stomach. It usually begins in the cells lining the esophagus and can be classified into two main types: squamous cell carcinoma and adenocarcinoma. As the cancer progresses, it can cause difficulty swallowing, weight loss, and chest pain. It may spread to nearby lymph nodes and other organs, such as the liver or lungs. The progression of esophageal cancer is influenced by factors like smoking, alcohol consumption, and chronic acid reflux. Early stages may be asymptomatic, making early detection challenging.