RecruitingPHASE2INTERVENTIONAL

Preoperative Planning With PSMA-PET in Melanoma Surgery Trial

This research study is for men (aged 18 and over) who have melanoma, a type of skin cancer, that has spread to their lymph nodes or a few other places. The study is trying out a new type of scan called a PSMA PET/CT scan. This scan uses a special dye (68Ga-PSMA) to highlight cancer cells. Doctors want to see if this new scan can pinpoint melanoma spread more accurately than the usual scans, especially in tricky areas. If it works better, it could help surgeons plan operations more precisely, potentially leading to less extensive surgery and a quicker recovery. We are comparing it to the standard PET/CT scan to see if it offers a clearer picture by reducing background signals, which could make it easier to spot cancer.

At a glance

Status

Recruiting

Phase

PHASE2

Sponsor

Royal Marsden NHS Foundation Trust

Enrolment target

Start

11 Mar 2025

Estimated completion

31 Dec 2025

Malignant Melanoma

What is this study about?

This research is looking at a new way to find out if melanoma, a serious form of skin cancer, has spread in men. When melanoma spreads, it often goes to nearby lymph nodes (small glands that are part of your immune system). Surgeons need to know exactly where the cancer is to plan the best possible operation.

The study uses a special type of scan called a PSMA PET/CT scan. Before this scan, a small amount of a special dye called 68Ga-PSMA is put into your body. This dye is designed to stick to melanoma cells, making them light up on the scan. We want to see if this new scan can show the spread of melanoma more clearly and accurately than the scans currently used. Often, standard scans can show other parts of the body, like the brain and liver, lighting up, which can sometimes make it harder to see the cancer.

By getting a clearer picture, doctors hope to better understand exactly where the cancer is. This could mean surgeons can remove only the necessary parts, leaving more healthy tissue. This might lead to less extensive surgery, potentially meaning you recover faster and have fewer side effects from the operation.

Key takeaways

This study is testing a new scan (PSMA PET/CT) for men with melanoma.
It aims to find melanoma spread more precisely than standard scans.
Better pictures could help surgeons plan operations more accurately.
Participation involves having the new scan and comparing it to your usual scan.
This is a research study to improve future melanoma care.
You can stop participating at any time.

Who may be eligible?

This study is specifically for men aged 18 or older. You would be considered for the study if you have melanoma that doctors can feel in your lymph nodes or has spread a little bit to other areas.

To be considered, you must have already had a standard scan (called an FDG PET-CT scan) as part of your usual care, and your doctors must be planning surgery to remove the main melanoma area.

There are certain reasons you wouldn't be able to join. For example, if you can’t give your permission in writing, or if you can't complete all the study appointments. Also, if you're taking certain medicines for prostate issues, have had prostate cancer, or have had certain treatments or tests recently, you wouldn't be able to take part. Only men who are fluent in English can participate.

Quick self-check

Are you a man aged 18 or older?
Do you have melanoma that has spread to your lymph nodes or a few other places?
Have you already had a standard FDG PET-CT scan?
Are you scheduled for surgery for your melanoma?
Can you provide written consent and attend all study appointments?
Are you not currently receiving or have recently received certain prostate-related treatments or had prostate cancer?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you join this study, you will have a special scan called a PSMA PET/CT scan. This means a small amount of a dye (68Ga-PSMA) will be put into your body, and then you'll have the scan. You will already have had a standard FDG PET-CT scan as part of your routine care, and both scans will be compared. The study involves attending specific appointments for these scans and following the study instructions. The total duration of your involvement will depend on the scheduling of these scans and your planned surgery.

Potential risks and benefits

Taking part in this study might help doctors learn more about finding melanoma spread, which could benefit future patients. For you, it might provide a more detailed picture of your cancer, which could help your surgical team plan your operation more precisely. As with any medical procedure, there are minor risks associated with the scans, such as a small amount of radiation exposure or a reaction to the dye, but these are generally low. Remember, you can choose to leave the study at any time, for any reason, without it affecting your medical care.

Locations (1)

The Royal Marsden NHS Foundation Trust
London, United Kingdom· Recruiting

Common questions

What is melanoma?

Melanoma is a serious type of skin cancer that can spread to other parts of the body.

What is a PET/CT scan?

It's a medical imaging scan that combines two types of images to show detailed pictures of your body and how your cells are working.

What is 68Ga-PSMA?

It's a special 'tracer' or dye used in the new scan. It's designed to stick to certain cancer cells so they can be seen on the scan more clearly.

Will this scan change my treatment?

The goal is to provide more information to plan surgery better, but it's a research study comparing scans. Your doctors will discuss your treatment plan with you.

Is this a new medicine?

No, this study is testing a new way of using a scan to find cancer, not a new medicine or treatment for melanoma itself.

How to find out more

Reyhaneh Sadegh Zadeh

reyhaneh.sadeghzadeh@rmh.nhs.uk 020 7352 8171 Official trial record

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