RecruitingNAINTERVENTIONAL

STING MARK Universal Fiducial Marker System

This study is looking at a new type of tiny marker called STING-MARK. Currently, the way doctors mark a tumour's exact spot can be tricky and not always reliable. This new STING-MARK device is designed to be easily and precisely put into an organ using a needle, even after a biopsy. It helps doctors use special imaging to guide treatments to the tumour very accurately. We are testing this device to see how easy it is to use, how well it shows up on X-rays, and if it stays securely in place. We're doing this by testing it on organs that have been removed from patients for other medical reasons.

At a glance

Status

Recruiting

Phase

Sponsor

Centre hospitalier de l'Université de Montréal (CHUM)

Enrolment target

100

Start

28 Feb 2022

Estimated completion

01 Nov 2027

Cancer

What is this study about?

Imagine doctors need to treat a very specific spot inside your body, like a tumour. To do this accurately, they often rely on tiny markers that show up on scans like X-rays. These markers help them aim their treatments precisely.

Right now, the ways doctors place these tiny markers can be a bit tricky and not always perfect. This can make it harder to target treatments exactly where they're needed. This study is testing a brand-new type of marker called STING-MARK. It's designed to be much easier to use, more precise, and more reliable than current markers. It's a tiny, special device that can be put in place with a needle, helping doctors pinpoint the tumour's location for guided treatments.

We want to make sure the STING-MARK works as expected. So, we're testing it on organs that have already been removed from patients for surgery or transplantation. This allows us to see if the device is easy to insert, if it shows up clearly on X-rays, and if it stays where it's supposed to. This study is an important first step to check that the STING-MARK is safe and effective before it can be used in patients. It helps doctors give more focused and effective treatments in the future.

Key takeaways

A new type of marker (STING-MARK) is being tested to improve tumour targeting.
The study uses organs already removed during surgery, not directly on patients.
There are no direct risks or changes to your care if you participate.
Results could help doctors give more precise and effective treatments in the future.
You must be 18 or older and having specific organ surgery to be eligible.
Your decision to participate or not will not affect your medical treatment.

Who may be eligible?

This study is collecting organs from people who are having surgery to remove a solid organ, or from people who are receiving an organ transplant and a damaged organ is being removed.

You wouldn't need to do anything extra. If you are having one of these surgeries, and you agree, a small part of the organ that is already being removed for your medical care would be used for this research after the doctors have finished their usual checks.

There are no specific reasons that would prevent you from being included if you fit one of these groups. You just need to be 18 years old or older. The study includes both men and women.

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?
Are you having surgery to remove a solid organ?
Are you receiving an organ transplant, where a damaged organ is being removed?
Do you want to help research that could improve future cancer treatments?

Answer every question to see your result.

What does participation involve?

This study does not involve patients directly once the organ has been removed. If you choose to take part, it means that suitable organs, which are already being removed from you during surgery (either for an organ removal or a transplant), might be used for this research.

After your surgery, the pathology team (who examine tissues for diagnosis) will first do their routine checks on the removed organ. Once they are finished, if you have given your consent, a part of the leftover organ will be given to the research team. The research team will then insert the STING-MARK devices into this part of the organ and take X-rays to see how well they show up and if they stay in place. The organs are then returned for standard processing. You won't have any extra visits, tests, or changes to your medication. The total duration of your involvement is only the time it takes for the research team to use the removed organ post-surgery.

Potential risks and benefits

Since this study only involves organs that have already been removed from your body for medical reasons, there are no direct risks to you as a patient by participating. Your surgery will proceed as planned, and participation will not affect your recovery or care. There are also no direct benefits to you as an individual patient, however, the information we gain from this study could help improve how doctors precisely target treatments for future patients with cancer, leading to better care for others. You have the right to change your mind and withdraw your consent for your organ to be used for research at any time, without it affecting your medical care.

Locations (1)

CHUM
Verified postcode
Montreal, Canada· Recruiting

Common questions

What is a 'fiducial marker'?

It's a tiny, special marker that doctors place in the body to make a specific spot, like a tumour, show up clearly on scans (like X-rays) for accurate treatment.

Will this study affect my surgery or recovery?

No, absolutely not. The study only uses organs that have already been removed during your surgery for medical reasons, and it happens after your procedure is complete.

What is the purpose of testing the marker on removed organs?

By testing it on removed organs, researchers can safely check how well the marker works, how easy it is to use, and if it stays in place, before it's used in patients.

Will my personal information be shared?

No. Your privacy is very important. Only the removed organ will be used for research, and your personal information will not be shared with the research team carrying out the testing.

Can I still say 'no' to participating?

Yes, you have the right to say no at any time, even if you first agreed. Your medical care will not be affected in any way by your decision.

How to find out more

Moishe Liberman, MD

moishe.liberman@umontreal.ca 514-890-8000 Official trial record

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