RecruitingOBSERVATIONAL

Immune Checkpoint Inhibitor Therapy for Cancer and Risk of Myocarditis or Cardiomyopathy

This study is investigating a potential heart problem that can arise from certain cancer treatments. Newer cancer medications, known as immune checkpoint inhibitors, have greatly improved the lives of many patients, particularly those with serious cancers like melanoma. However, these powerful drugs can sometimes lead to side effects, including inflammation of the heart muscle (myocarditis) or other heart conditions. The study aims to use a special type of heart scan called Cardiac MRI (CMR) to detect early changes in heart tissue. By identifying these changes sooner, doctors hope to better understand and manage these heart-related side effects, potentially preventing serious heart problems and improving patient safety during cancer treatment.

At a glance

Status

Recruiting

Sponsor

Sunnybrook Health Sciences Centre

Enrolment target

Start

01 Jun 2024

Estimated completion

31 Dec 2025

Cardio-Oncology Cardiomyopathy Due to Drug

What is this study about?

This study focuses on a specific challenge that can arise for people undergoing modern cancer treatments. Over recent years, new medications called immune checkpoint inhibitors (ICI for short) have revolutionised how we treat many cancers, including advanced skin cancer (melanoma). These drugs help your body's immune system fight cancer more effectively, leading to much better outcomes and longer lives for many patients.

While these treatments are fantastic for fighting cancer, like all powerful medicines, they can have side effects. One particular concern that doctors are learning more about is the potential for these drugs to affect the heart. In some cases, they can cause inflammation of the heart muscle (called myocarditis), which can be very serious. Other heart problems or changes might also occur. At the moment, it's difficult for doctors to predict who might be at risk or to spot these issues early.

That's where this study comes in. We want to use a special, detailed type of MRI scan for the heart, called a Cardiac MRI (CMR). This scan is very good at looking closely at the heart muscle and can help us see tiny changes in the tissue. By doing these scans during treatment, we hope to find early signs of heart problems before they become serious. This could help doctors understand why these problems happen, identify patients who need extra care sooner, and potentially develop ways to prevent or better treat these heart side effects, ensuring patients can continue to benefit from their cancer treatment safely.

Key takeaways

This study investigates how certain cancer drugs might affect your heart.
It uses special heart MRI scans to look for early changes in heart tissue.
The goal is to better understand and manage potential heart side effects from cancer treatment.
Better monitoring could help prevent serious heart problems for patients.
This research focuses on patients receiving immune checkpoint inhibitors for skin cancer.

Who may be eligible?

To be considered for this study, you would need to be at least 18 years old and have skin cancer that your doctor plans to treat with specific immune checkpoint inhibitor drugs such as nivolumab, pembrolizumab, or ipilimumab. It's also important that you are able to understand the study information and agree to take part, and that you can travel to the hospital (SHSC) for the heart scans.

There are certain reasons why you might not be able to join. For example, if your doctors expect you to live for less than 12 months, or if you're already taking part in another research study. You also couldn't join if you've had immune checkpoint inhibitor treatment before, or if you have a history of certain heart problems like heart failure, a past heart attack, or an irregular heartbeat (atrial fibrillation).

Other reasons for not being able to take part include if you are pregnant, have severely reduced kidney function, or if you have any medical devices in your body (like a pacemaker) that would make having an MRI scan unsafe.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Do you have skin cancer and are you planned to receive nivolumab, pembrolizumab, or ipilimumab?
Are you able to travel to SHSC for heart scans?
Have you NOT had previous immune checkpoint inhibitor treatment?
Do you NOT have a history of serious heart problems (e.g., heart failure, past heart attack)?
Are you NOT pregnant and do you NOT have an MRI-unsafe device (like a pacemaker)?

Answer every question to see your result.

What does participation involve?

The detailed description of what taking part involves is not fully provided in the summary. However, based on the information, if you join this study, it would involve regular visits to the hospital (SHSC). During these visits, you would have special heart scans called Cardiac MRI (CMR). These scans allow doctors to look closely at your heart muscle. The study aims to follow how your heart changes during your cancer treatment. The exact number of visits, how long each scan takes, and the total length of your participation are not specified but would be fully explained by the study team after you've expressed interest.

Potential risks and benefits

Taking part in this study could potentially offer benefits by allowing doctors to closely monitor your heart health during your cancer treatment, possibly catching any heart-related side effects earlier than usual. This might lead to quicker or better management of any heart issues that arise. However, there are also potential risks. MRI scans, while generally safe, involve being in a confined space and can sometimes cause discomfort. There's also the risk of receiving information about your heart that might lead to further tests or worry. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Sunnybrook Health Sciences Center
Verified postcode
Toronto, Canada· Recruiting

Common questions

What are immune checkpoint inhibitors?

They are a type of cancer drug that helps your body's immune system recognise and attack cancer cells more effectively.

What is myocarditis?

Myocarditis is inflammation of the heart muscle, which can sometimes be a side effect of certain cancer treatments.

What is a Cardiac MRI (CMR)?

It's a special type of scan that uses magnets and radio waves to create detailed pictures of your heart, helping doctors see its structure and how well it's working.

Will taking part in this study change my cancer treatment?

The study aims to monitor your heart, but it does not specify any changes to your planned cancer treatment itself.

Is the Cardiac MRI safe?

CMR is generally safe, but there are certain conditions (like having a pacemaker) that make it unsuitable. The study team would check this carefully.

How to find out more

Christian Houbois, MD

christian.houbois@sunnybrook.ca (416) 480-6100 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.