A trial of fluorescence guided surgery for sarcoma

Full title: SarcoSIGHT: A Randomised-Control Trial of Fluorescence Guided Sarcoma Surgery Versus the Standard of Care

Age: Any

Phase: Other

Locations:

Brief summary: 

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.

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

The team are recruiting 500 people.

This is a randomised trial, where people will randomly allocated by a computer into two groups. 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 to have a dye called indocyanine green given as a IV drip into a vein. The dye will show up in the sarcoma under special lighting during surgery. The surgeon will use scans taken before surgery and this dye as a guide to remove sarcoma.

Standard surgery
Those having standard surgery will not receive the dye and will have surgery using the scans taken beforehand.

Quality of life
Everyone will fill in a Quality of Life questionnaire before having surgery and then after surgery at:

• 1 month
• 3 months
• 6 months
• 1 year

To find out more about this trial and whether you could take part, talk to your clinical team.