A trial of fluorescence guided surgery for sarcoma (sarcoSIGHT)
Cancer type:
Status:
Phase:
This trial is comparing fluorescence guided surgery to 
for people with .
It is open to anyone who is due to have surgery with the aim to cure for:
- bone sarcoma or
- soft tissue sarcoma
More about this trial
Surgery is one of the main treatments for many types of soft tissue sarcoma and sarcoma of the bone. The aim of the surgery is to remove the sarcoma with a clear margin. The clear margin is normal tissue surrounding the sarcoma that has no sarcoma cells in it. Having a clear margin means it is less likely that any sarcoma is left in the body and therefore that the sarcoma will come back.
But getting a clear margin can be difficult because sarcoma can be large and deep in the body. This means that sarcoma cells may be left and could start to regrow.
So researchers are looking for ways to improve the surgery.
Before surgery you have scans of your sarcoma. This helps to guide the surgeon during the operation. But it can be difficult to relate the scan results to what they see during surgery.
In this trial they are looking at using a fluorescent dye during surgery that collects in the sarcoma. This is called fluorescence guided surgery. This might help the surgeon to see the sarcoma better and successfully remove it along with a clear margin. But they don’t know this for sure. So the team want to compare standard surgery with fluorescence guided surgery.
The aims of the trial are to find out:
- whether fluorescence guided surgery is better than standard surgery to remove the sarcoma with a clear margin
- whether there are fewer complications with fluorescence guided surgery
- how both surgeries affect
quality of life
Who can enter
The following bullet points are a summary of the entry conditions for this trial. Talk to your doctor or the trial team if you are unsure about any of these. They will be able to advise you.
Who can take part
You may be able to join this trial if all of the following apply. You:
- have bone sarcoma that is intermediate to high grade or soft tissue sarcoma that is intermediate to high grade
- are due to have surgery with the aim to cure
This trial is open to people of any age. If you are under the age of 16 your parent or legal guardian must give consent for you to take part.
Who can’t take part
You cannot join this trial if any of these apply. You:
- are having surgery to relieve symptoms such as pain. This is palliative surgery.
- have sarcoma that has come back
- have sarcoma in certain areas of the body. Your doctor will know which areas these are.
- are pregnant or breastfeeding
- are allergic to medical dye called ICG, iodine, iodine dyes or shellfish
Trial design
The team need 500 people to take part.
This is a randomised trial. A computer puts you into 1 of 2 groups. Neither you nor your doctor can choose which group you are in. The 2 groups are:
- fluorescent guided surgery
- standard surgery
Everyone has their surgery as planned.
Fluorescent guided surgery
Those having fluorescent guided surgery go into hospital the day before surgery. This is to have a dye called indocyanine green (ICG). You have ICG as a drip into a vein. The dye collects in the sarcoma and glows when the surgeon shines a special light on it during surgery.
Your surgeon plans your operation using the scans you have before your surgery. During surgery the surgeon can see the glowing of the dye using a special camera that uses near infra-red light. They use the glow as a guide to remove the sarcoma.
Standard surgery
Those having standard surgery don’t have the injection of ICG. Your surgeon plans your operation using the scans you have before your surgery. You might go into hospital the day before surgery or on the day of your operation. Your surgeon will go through what is going to happen in your situation.
Quality of life
Everyone fills in a questionnaire before having surgery and then after surgery at:
- 1 month
- 3 months
- 6 months
- 1 year
The questions ask about:
- how well you get around
- how you look after yourself
- your usual daily activities
- pain and discomfort
- whether you are feeling anxious or depressed
People who have sarcoma of the arm or leg
This part of the study is for people who have surgery to remove a sarcoma from their arm or leg, but don’t need to have a removal (amputation) of their limb. Surgery to the arm or leg can affect how well it works and the team want to assess this. So you also fill in a questionnaire about how difficult it is to do certain tasks using the affected limb.
These are quality of life questionnaires. You fill in the questionnaires online around the same time as some of your routine clinic appointments. The team send out an email with a link to the questionnaires around the time your clinic appointments are due.
Other studies
The team are doing 2 other studies that are linked to this study and are taking place alongside it:
- fluorescence mapping
- fluorescence microscopy
Fluorescence mapping
This is open to people having fluorescence guided surgery. The team want to develop a computer process. They hope that surgeons can use this to better understand and read the images taken by the near infra-red camera.
For this the team will use the images taken during your surgery. You cannot be identified from the images.
You don’t have to agree to this. You can still take part in the main trial.
Fluorescence microscopy
This study is only open to people who are having their treatment at the Newcastle upon Tyne hospitals.
After surgery the tissue samples from both groups are sent to the laboratory.
For the fluorescence guided surgery, the surgeon uses the dye to make sure all of the sarcoma is removed. They also remove some normal tissue around the sarcoma.
For the standard surgery, a In the laboratory stains the tissue samples to check that all of the sarcoma is removed. They also check that there are no sarcoma cells in the normal tissue around the tumour.
The team need 25 tissue samples from the fluorescent guided group and 25 tissue samples from the standard surgery group.
They will compare the tissue samples from the 2 groups. This is to find out which method is better at removing the sarcoma with a clear margin.
You don’t have to agree to this. You can still take part in the main trial.
Hospital visits
You see the doctor before taking part. This is to talk about the trial and see if you can join.
People in the fluorescent guided surgery group go into hospital the day before their surgery to have the IGC infusion. Those who have standard surgery might go into hospital the day before surgery or on the day of their operation.
Everyone has their surgery as planned.
After your surgery you stay in hospital until you recover. Then your surgeon will tell you how often they want to see you after the surgery. You don’t have any extra hospital visits after your operation as a result of taking part in this trial.
Side effects
The surgical team monitor you during surgery and afterwards until you recover enough to go back to the ward.
There is a small risk of an allergic reaction to the fluorescent dye. This happens in about 1 person in every 2,000 people.
With fluorescent guided surgery, there is a risk that the surgeon might rely too heavily on the camera and the fluorescent dye. This could result in them leaving
behind some sarcoma or taking out too much normal tissue.
We have more information about:
Your doctor will talk to you about the possible complications of surgery and the possible side effects of the fluorescent dye before you agree to take part. They will also answer any questions you might have.
Location
Recruitment start:
Recruitment end:
How to join a clinical trial
Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.
Chief Investigator
Mr Kenneth Rankin
Supported by
Newcastle upon Tyne Hospitals NHS Foundation Trust,
Newcastle Clinical Trials Unit, Newcastle University
NIHR Efficacy and Mechanism Evaluation (EME) Programme
If you have questions about the trial please contact our cancer information nurses
Freephone 0808 800 4040
