Recruiting

Study on Managing Rheumatological Side Effects in Cancer Patients Using Fludeoxyglucose (18F) and Checkpoint Inhibitors

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 clinical trial is focused on studying cancer and the effects of certain treatments on the immune system. The study involves patients with any type of cancer who are starting treatment with medications known as immune checkpoint inhibitors (ICIs). These medications include anti-PD1, anti-PDL1, and anti-CTLA-4 therapies, which help the immune system recognize and attack cancer cells. The trial aims to gather information on how these treatments might cause immune-related side effects, particularly those affecting the joints and muscles, known as rheumatological adverse events.

Participants in the study will receive a special injection called Fludeoxyglucose (18F)-Curium, which is a solution used to help visualize certain processes in the body. This solution is given through an intravenous infusion, meaning it is delivered directly into the bloodstream. The purpose of the study is to collect data on how often these immune-related side effects occur, how they affect patients with and without existing joint or muscle conditions, and how patients respond to treatment.

The study will follow participants over time to observe the development of these side effects and gather information on their health and treatment responses. This information will help doctors better understand and manage these side effects in the future, improving care for patients undergoing cancer treatment with immune checkpoint inhibitors.

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 informed about the purpose and procedures involved. The study aims to collect clinical data on the diagnosis and management of immune-related rheumatological adverse events, which are side effects that can occur when using certain cancer treatments known as immune checkpoint inhibitors.
Step 2
Eligibility confirmation
To participate, you must be at least 18 years old and have been diagnosed with any type of cancer. You will also need to be starting treatment with immune checkpoint inhibitors, which are a type of cancer therapy.
Step 3
Treatment administration
During the study, you will receive a medication called fludeoxyglucose (18F). This is administered as a solution for injection through an intravenous infusion, which means it is given directly into your vein. The dosage is 185 MBq/ml, but the frequency and duration of administration will be determined by the study team based on your specific needs.
Step 4
Monitoring and data collection
Throughout the study, your health will be closely monitored. The study team will collect data on any side effects you experience, particularly those related to rheumatological conditions, which affect the joints and muscles. This will help in understanding how these side effects occur and how they can be managed.
Step 5
End of study participation
The study is expected to continue until August 1, 2027. Your participation may end earlier if you complete the treatment or if the study team decides it is in your best interest to stop. At the end of your participation, you will have a final assessment to evaluate your health and any effects of the treatment.

Who can join the trial?

3 criteria

Must be at least 18 years old.
Must have been diagnosed with any type of cancer.
Must be starting treatment with immune checkpoint inhibitors (ICI). This includes treatments like anti-PD1, anti-PDL1, anti-CTLA-4, or other newly approved immune therapies. These can be used alone or in combination with other treatments.

Who cannot join the trial?

3 criteria

Patients who do not have any type of cancer.
Patients who are not within the specified age range for the study.
Patients who are part of a vulnerable population, which means groups that might need special protection or care.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Verified
Amsterdam UMC
Amsterdam, The Netherlands
Verified
Reade revalidatie & reumatologie centrum te Amsterdam
Amsterdam, The Netherlands
Verified
UMCG
Groningen, The Netherlands

Trial locations

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Investigated drugs

Checkpoint Inhibitors are a type of medication used in cancer treatment. They work by helping the immune system recognize and attack cancer cells. Normally, the immune system has checkpoints that prevent it from attacking healthy cells. However, cancer cells can use these checkpoints to hide from the immune system. Checkpoint inhibitors block these checkpoints, allowing the immune system to detect and destroy cancer cells more effectively. This study is focused on understanding the side effects related to these medications, particularly those affecting the joints and muscles, and how to manage them.

What is already known about the treatment

Checkpoint Inhibitors – Checkpoint inhibitors are medications administered through intravenous infusion, meaning they are given directly into the bloodstream through a vein. These drugs are currently well-established in medical practice and literature, particularly in the treatment of various types of cancer. They are primarily used to help the immune system recognize and attack cancer cells more effectively. At the molecular level, checkpoint inhibitors work by blocking proteins that prevent the immune system from attacking cancer cells, essentially taking the brakes off the immune response. They belong to a class of drugs known as immunotherapy agents, which harness the body's immune system to fight cancer.

Investigated diseases

Cancer – Cancer is a group of diseases characterized by the uncontrolled growth and spread of abnormal cells. It can develop in almost any organ or tissue, such as the lungs, colon, breast, skin, bones, or nerve tissue. The progression of cancer involves the transformation of normal cells into malignant ones, which can invade nearby tissues and spread to other parts of the body through the blood and lymph systems. As cancer progresses, it can form tumors, which may interfere with the normal function of organs and tissues. The rate of progression varies widely depending on the type of cancer and its location. Some cancers grow slowly and may not cause symptoms for a long time, while others can grow rapidly and cause significant health issues.