Are patient outcomes improved by surgery that uses a glowing dye to illuminate a cancerous tumour?

Plain English summary of protocol

Background and study aims
Sarcomas are rare types of cancer, making up only 1% of all cancer cases in the UK, with about 5300 new diagnoses each year. What sets sarcomas apart is that they affect people across a wide range of ages, especially younger individuals. On average, patients are diagnosed with sarcomas at the age of 56. Unfortunately, the survival rates for sarcomas aren't great, with only about 65% of patients surviving five years after diagnosis. For those with higher grade sarcomas, the survival rate drops to 50%, and these numbers haven't improved much over the last 30 years.

The main treatment for sarcomas is surgery, with the goal of removing the tumor completely while preserving as much healthy tissue as possible. But here's the problem: during surgery, it's often challenging for the surgeon to distinguish between the tumor and healthy tissue by sight and touch alone.

One of the most critical factors in predicting a patient's outcome after surgery is the "resection margin." This margin is determined by pathologists who examine the removed tissue in a lab. A "negative margin" means that the tumor was completely surrounded by healthy tissue, suggesting that no cancer was left behind. On the other hand, a "positive margin" means that tumor cells are still present at the edge of the removed tissue. This is a bad sign because it's linked to a higher risk of cancer recurrence and poorer overall survival for the patient.

To improve outcomes for sarcoma patients, we're exploring a promising technology called fluorescence-guided surgery (FGS). FGS involves injecting a special dye called indocyanine green (ICG) into the patient before surgery. The tumor absorbs this dye, making it glow when viewed through a special camera during surgery. ICG has been used safely for years in other medical procedures. Recent research has shown that it can also help surgeons identify healthy tissue from diseased or poorly vascularized tissue during surgery.

A recent case series suggested that using FGS with ICG for high-grade sarcoma removal may reduce the rate of positive margins. Therefore, we're conducting a randomized controlled trial to investigate this further. This trial will include sarcoma patients of all ages and subtypes, except low-grade sarcomas that don't fluoresce. It's an important step toward improving outcomes for sarcoma patients by reducing the risk of positive margins, which are associated with worse short-term and long-term outcomes.

Our study aims to compare the rate of positive margins between FGS using ICG and standard surgery. This is crucial because positive margins are linked to a higher risk of cancer recurrence and poorer survival for patients. Ultimately, this research could lead to better surgical techniques and better outcomes for sarcoma patients.

Who can participate?
Any individual of any age who has been diagnosed with an intermediate to high-grade sarcoma in their bones or soft tissues, and can undergo surgery with the aim of curing the disease, can join the study. However, if someone is currently pregnant or breastfeeding, they won't be able to participate. Also, those with certain conditions won't be eligible. This includes individuals with tumors that have come back, tumors located in specific places like the inner organs, abdomen, or brain, anyone who's allergic to a substance called ICG, iodine, iodine dyes, or shellfish, and those who can't provide written consent for the study.

What does the study involve?
Once a patient has agreed to participate in the trial, the research team will use a method called "randomization" to decide which group they will be in. Both the patient and their doctor will be informed about this randomization outcome.

If a participant is placed in the group that gets the special surgery called "Fluorescence Guided Surgery using Indocyanine Green" (FGS with ICG), they will need to come to the hospital one day before their surgery.

On the other hand, participants in the control group will come to the hospital as inpatients either on the day before their surgery or on the day of surgery, depending on what their care team decides based on their specific medical needs.

For those in the FGS with ICG group, they'll come to the hospital a day before surgery to receive an injection of ICG dye. A nurse or doctor will give this injection through a vein, and it will be done 12-24 hours before the actual surgery.

For participants in the control group, they will receive the standard surgery. This involves surgeons using pre-operative images to locate the sarcoma in the body and using their hands to feel for the edges of the tumor to help with the removal.

However, participants in the FGS with ICG group will have an extra step during surgery. They will also use a special near-infrared camera that shows real-time images of the tumor, which has absorbed the ICG dye and glows. The surgeon will use these images to guide them during the tumor removal.

After the surgery, all participants will receive the usual post-operative care, just like any other patient in a standard care setting.

We will gather information about the surgery from the surgeon, including how long it took, how much of the tumor they think might still be in the patient, if there were any complications during surgery, and if using the camera had any impact on the surgeon's decisions.

Additionally, at baseline and 1, 3, 6, and 12 months after the surgery, participants will be asked to fill out some questionnaires like EQ-5D-5L/EQ-5D-Y and TESS/pTESS (if applicable) to help us track their progress and well-being.

What are the possible benefits and risks of participating?
There is no direct benefit to the participants for taking part in the trial. However, they may have access to a treatment (i.e., FGS using ICG) not normally provided as standard of care on the NHS. Patients in the future may potentially benefit from the information gained.

Both surgical methods for resection of sarcoma are used in NHS hospitals although FGS using ICG is not currently standard of care. Therefore the risk to patients taking part in the trial are no greater than their risks of having the surgery outside of the trial.
The burden to the participants are considered to be low. Aside from the surgery and follow up appointments at 6- and 12-months, which would be taking place in side or outside the trial, participants will be asked to complete some questionnaires. All participants will be asked to complete the quality of life questionnaire the EQ-5D-5L/ EQ-5D-Y and if they have had a sarcoma effect on of their extremities they will also be asked to complete the Toronto Extremity Salvage Score. Both questionnaires take about 10-15 minutes each to complete. The questionnaires will be completed at baseline, then at 1-, 3-, 6- and 12 months post surgery. Completing the questionnaires will not require extra hospital visits and will be sent to participants electronically.

Where is the study run from?
Newcastle Clinical Trials Unit, part of Newcastle University (UK)

When is the study starting and how long is it expected to run for?
July 2023 to April 2028

Who is funding the study?
1. NIHR Efficacy and Mechanism Evaluation Programme (UK)
2. Stryker (UK)

Who is the main contact?
sarcosight@newcastle.ac.uk

https://www.cancerresearchuk.org/about-cancer/find-a-clinical-trial/a-trial-of-fluorescence-guided-surgery-for-sarcoma-sarcosight

Contact information

Mr Kenneth Rankin
Scientific, Principal investigator

Freeman Hospital
High Heaton
Newcastle upon Tyne
NE7 7DN
United Kingdom

ORCID ID	0000-0001-6302-0269
Phone	+44 (0) 191 213 9953
Email	kenneth.rankin1@nhs.net

Newcastle Clinical Trials Unit
Public, Scientific

Newcastle University
Baddiley-Clark Building
Richardson Road
Newcastle upon Tyne
NE2 4AX
United Kingdom

Email	sarcosight@newcastle.ac.uk

Study information

Eligibility

Locations

Countries of recruitment

• United Kingdom
• England
• Northern Ireland
• Scotland
• Wales

Study participating centres

Results and Publications

Study outputs

Editorial Notes

01/05/2026: The IRAS number was changed from 324220 to 1012390.
21/04/2026: The following changes were made to the study record:
1. The ethics approval (2) was added.
2. The key secondary outcome(s) were changed.
3. The key inclusion criteria were changed.
4. The key exclusion criteria were changed.
5. The Date of final enrolment was changed from 30/04/2026 to 30/04/2027.
17/04/2026: Contact details updated.
17/12/2024: Recruitment to the SarcoSIGHT trial was paused on 14th November 2024 and will remain paused for recruitment while certain MHRA requirements are being addressed. The study team are continuing to follow-up existing trial patients and to collect information from them. An update on the status of the trial will be provided as soon as it becomes available.
24/09/2024: Website link added.
24/04/2024: Cancer Research UK link added to plain English summary field.
12/02/2024: The recruitment start date was changed from 01/02/2024 to 01/03/2024.
08/11/2023: The recruitment start date was changed from 01/11/2023 to 01/02/2024.
03/10/2023: Trial's existence confirmed by the National Institute for Health and Care Research (NIHR) (UK).