Background to SarcoSIGHT
With sarcoma it is important to remove all the tumour and not leave any behind. This can be difficult, because these tumours can be large and deep in the body, which means small amounts of tumour are sometimes missed.
The technology to help guide surgeons in these procedures are the scans you have before the operation. However, it can be difficult for the surgeons to relate these images to what they see during the operation.
Fluorescence guided surgery is a new technique in which a dye is given to patients the day before their surgery. The dye is infused directly into the patient’s veins by inserting a needle attached to a thin tube and releasing the dye into the tube in a short procedure. The infused dye collects in the tumour.
During the operation this dye might help the surgeon to see the tumour better when it is viewed through a special camera using infra-red light. Currently, we do not know whether this technique improves a surgeon’s ability to remove all the tumour more often than when using standard techniques.
We need a trial like SarcoSIGHT to provide the information needed to decide which is the best technique. This information will allow us to provide better care to patients, like yourself, in the future.
Trial Design
SarcoSIGHT is a prospective, 2-arm, open-label, UK multi-centre, randomised control trial comparing fluorescence-guided surgery (FGS) with indocyanine green (ICG) to standard care (no fluorescence guidance) to determine the effect on the unexpected positive margin rate (UPM) in patients with sarcoma.
Aim;
The aim of this trial is to find out if one technique is better than the other for removing the whole tumour.
Trial Population
The SarcoSIGHT (Sarcoma Surgery Intraoperative Guidance to Highlight Tumour) trial will include 500 patients across up to 17 UK sites and compare two different surgical techniques that are currently used in the NHS for sarcoma surgery.
Outcomes
Primary Objectives To determine whether there is a reduction in the unexpected positive margin rate (UPM) in patients receiving fluorescence-guided surgery (FGS) using indocyanine green (ICG) compared to standard of care (SoC).
Secondary Objective(s) To determine the effect of FGS using ICG compared to the SoC over a 12-month period on the following areas:
- Complications
- Length of index operation
- Length of inpatient stay
Related Investigations:
There are two related investigations that will be taking place alongside this main trial; Fluorescence mapping and Fluorescence microscopy.
Fluorescence Mapping
We would like to develop automatic computer processes that will match the fluorescent dye seen on the images produced by the infra-red camera with the information about the tumour detailed in the post-surgery pathology report. The aim is to help the surgeon interpret the images taken on the infrared camera in future.
Fluorescence Microscopy
We would like to see how good the fluorescent dye is at finding all parts of the tumour at a cellular level. We will be comparing this to the current method of applying a stain to the tumour in the laboratory. Specifically, we are looking to see how effective both techniques are at finding the edge of the tumour. This will involve comparing tissue samples from 25 patients who had surgery using the fluorescent dye and tissue samples from 25 patients who had the standard surgery. The tissue samples will be analysed at NovoPath Newcastle MRC Node, which is a research laboratory at the Royal Victoria Infirmary in Newcastle upon Tyne.
Are you eligible?
Inclusion Criteria
1. Patients of any age
2. Capacity to provide written, informed consent (or legal guardian if <16 years of age)
3. Histologically confirmed diagnosis of intermediate to high grade sarcoma
4. Amenable to surgical resection as a part of curative intent for the patient
Exclusion Criteria
1. Due for surgery with palliative intent
2. Recurrent tumours
3. Intracranial, retroperitoneal, and visceral anatomical locations
4. A woman of child bearing potential* who is currently pregnant (as confirmed by urine pregnancy test)
5. A woman who is currently breastfeeding
6. Known allergy to ICG, iodine, iodine dyes or shellfish.
7. Unable to provide written, informed consent
8. Patients with hyper-thyroidism or autonomic thyroid adenomas
9. Premature infants/neonates with exchange transfusion indication due to hyperbilirubinemia