RecruitingPhase IIInterventional

A trial of indocyanine green and near-infrared fluorescence in paediatric oncology surgery

Surgery is an important part of treatment for many young people with cancer, but fully removing a tumour without harming healthy tissue can be difficult. The GLO-Surgery study is testing a special medical dye called indocyanine green (ICG) to see if it makes operations safer and more effective. ICG is injected into the body before surgery. When doctors shine a special near-infrared light camera on the area, the dye glows. This helps surgeons clearly see the edges of tumours in the chest or tummy, as well as nearby lymph nodes where cancer cells might hide. Patients taking part are chosen by a computer to either have their surgery with the dye or have standard surgery without it. Because ICG has been safely used in medicine for over 60 years, researchers hope this trial will show whether it can help improve surgical outcomes for young cancer patients.

At a glance

Status

Recruiting

Phase

Phase II

Sponsor

University of Birmingham

Enrolment target

290

Start

06 May 2025

Estimated completion

31 Mar 2027

Non-central nervous system solid tumours, or pulmonary metastasis, where complete resection by keyhole or open surgery is planned

What is this study about?

For many children and young people with cancer, an operation to remove the tumour is a vital step toward getting better. However, operating on solid tumours can be tricky. It is hard for surgeons to see where the cancer ends and healthy body parts begin. If tiny pieces of a tumour are missed, the cancer could return. At the same time, surgeons must be extremely careful not to damage nearby healthy organs or take away healthy tissue by accident.

This clinical study, known as GLO-Surgery, is testing a technique called fluorescence-guided surgery. It uses a medical dye named indocyanine green (ICG). When doctors inject this dye into the bloodstream or near a tumour, it gathers in cancer cells and nearby lymph nodes (small glands that filter body fluid). During the operation, surgeons use a camera that shines an invisible near-infrared light. This causes the dye to light up on their monitors, acting like a glowing map inside the body.

The goal of the study is to find out if this glowing dye makes cancer surgery safer, easier, and more thorough. By clearly lighting up the tumour and hidden lymph nodes, it could help surgeons remove all the disease in one go while protecting healthy organs. This could lead to better long-term recoveries for children and young people undergoing major cancer operations.

Key takeaways

The study tests whether a glowing dye (ICG) helps surgeons see tumours and lymph nodes more clearly.
It is open to children and young people having planned surgery for solid tumours in the chest or tummy.
Most patients are randomly assigned to either receive the dye or have standard surgery without it.
The dye has been used safely in medicine for over 65 years, with very low risk of side effects.
Taking part will not change the standard medical care or the timing of the planned operation.

Who may be eligible?

This trial is open to children, teenagers, and young adults who have a solid tumour in their chest, their tummy (abdomen), or a tumour that has spread to their lungs, and who are already scheduled to have surgery to remove it. Because some rare cancers need special attention, all patients with a specific type of tumour called paratesticular rhabdomyosarcoma will automatically receive the dye.

Patients cannot take part if they have a known allergy to indocyanine green or iodine, or if they have an overactive thyroid gland (hyperthyroidism). It is also not suitable for people with severe kidney problems, those who are breastfeeding, or anyone planning to have radioactive iodine therapy soon.

Because the safety of the dye during pregnancy is unknown, female patients of childbearing age must have a negative pregnancy test before joining. Sexually active young people who could become pregnant or father a child must also agree to use reliable contraception while taking part in the trial.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

You or your child has a solid tumour in the chest, tummy, or lungs planned for surgical removal.
You do not have a known allergy to iodine or indocyanine green.
You do not have severe kidney problems or an overactive thyroid (hyperthyroidism).
You are not currently pregnant or breastfeeding.
If applicable, you agree to take a pregnancy test and use reliable contraception during the study period.

Answer every question to see your result.

What does participation involve?

If you or your child take part, you will have your planned operation as scheduled at your hospital. In most cases, a computer will randomly place you into one of two groups: one group will receive the glowing dye alongside their surgery, while the other group will have standard surgery without the dye. Both groups will receive the full standard care and surgical treatment.

If chosen to receive the dye, it will be given through a drip or as a small injection into the tissue before the operation starts. The surgical team will use special cameras during your keyhole or open surgery to look for glowing areas. Aside from receiving the dye and having the camera used during the procedure, your hospital stay and recovery will follow the usual path for your type of surgery. The overall study will run from May 2025 until April 2028, and your medical team will check on your recovery during regular post-surgery follow-up appointments.

Potential risks and benefits

The main hope of this study is that the glowing dye helps the surgeon see the cancer more clearly, making the operation safer and ensuring all of the tumour is removed. However, there is no guarantee that taking part will bring direct personal benefits. Indocyanine green has been used safely in medicine for over 65 years, but there is a very small risk of an allergic reaction (less than 1 in 10,000 people). You can choose to stop taking part at any time without giving a reason, and your regular medical care will not be affected in any way.

Locations (7)

Birmingham Childrens Hospital
Approximate
Birmingham, England
Oxford University Hospitals
City only
Oxford, England
Southampton General Hospital
Approximate
Southampton, England
Addenbrooke's Hospital
Approximate
Cambridge, England
Great Ormond Street Hospital for Children
Approximate
London, England
Royal Hospital for Sick Children (Glasgow)
Unverified
Glasgow, Scotland
Prinses Maxima Centrum Voor Kinderoncologie
Unverified
Utrecht, Netherlands

Common questions

What is indocyanine green (ICG)?

It is a medical dye that has been safely used in healthcare for decades. When viewed under a special near-infrared light camera, it glows bright green, helping doctors see blood vessels, tumours, and lymph nodes.

Will taking part delay the planned surgery?

No. The dye is given shortly before your already planned operation, so joining the trial should not cause any delays to your surgical care.

Can I choose whether to receive the dye?

For most patients, a computer randomly decides who receives the dye and who does not. This is done to make sure the trial results are completely fair. The only exception is for patients with a very rare cancer called paratesticular rhabdomyosarcoma, who will all receive the dye.

Will the dye change the colour of my skin?

The dye does not typically change your visible skin colour in ordinary light, but it will glow on the surgeon's special camera monitor during the operation.

What happens if I change my mind later?

Joining the trial is entirely voluntary. You or your family can choose to leave the study at any time, and you will continue to receive the best standard care available.

How to find out more

GLO-Surgery Trial Management Team

glosurgery@trials.bham.ac.uk +44 (0)121 415 9877 Official trial record

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