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Indocyanine Green Fluorescence Imaging for Flap Perfusion in Head and Neck Cancer Reconstruction Surgery

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is being done in Head and neck cancer. It studies the use of indocyanine green, given into a vein, during surgery to help check blood flow in a tissue flap used for head and neck reconstruction. A flap is a piece of tissue moved during surgery to rebuild an area after cancer treatment. The purpose of the study is to see whether this imaging method can help reduce the risk of part of the flap not getting enough blood and needing another operation.

People in the study are placed into one of two groups. One group has the blood flow checked with indocyanine green fluorescence imaging, which means the dye is used so the surgeon can see how blood moves through the flap. The other group is checked with standard clinical assessment, which means the usual way of judging the flap during surgery. After the operation, the flap is followed for a short time to see how it heals and whether any further treatment is needed.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Start of the trial
You enter the trial after joining it. The trial is called the VISION Trial and is for people having head and neck reconstruction because of head and neck cancer.
During the operation, your flap, which is a piece of tissue used to rebuild the area, is checked in one of two ways: either with indocyanine green fluorescence imaging or with standard clinical assessment. Standard clinical assessment means the usual doctor checks used to judge blood flow in the flap.
Step 2
Study medicine during surgery
If you are assigned to the imaging group, you receive indocyanine green as a 75 mg dose given by intravenous administration. Intravenous administration means the medicine is given into a vein.
The medicine is supplied as a solution for injection. It is used during the operation to help check flap blood flow.
Step 3
Immediate surgical assessment
During the operation, your flap is assessed to see whether it has enough blood flow. This assessment is done either with the imaging method using indocyanine green or with standard clinical methods.
The result of this assessment is used to guide the surgical care of the flap during the operation.
Step 4
First month after surgery
For 1 month after surgery, the trial checks whether there is partial flap loss that requires surgical intervention. Partial flap loss means that part of the tissue used for reconstruction does not survive and needs another operation.
During this same period, the trial also checks for total flap loss, flap-related re-exploration under general anaesthesia, and flap salvage. General anaesthesia means medicine is given so that you are asleep during surgery. Flap salvage means saving the flap after a problem is found.
Step 5
Up to three months after surgery
For 3 months after surgery, the trial records postoperative complications. Postoperative complications means health problems that happen after the operation.
These complications are graded using the Clavien-Dindo classification, which is a system used to describe how serious a complication is.

Who can join the trial?

4 criteria

The person must be able to give informed consent, which means they understand the study and agree to take part voluntarily.
The person must be older than 18 years.
The person must be scheduled to have microvascular free flap reconstruction, which is surgery that moves tissue with very small blood vessels to rebuild an area.
The surgery must be for a head and neck defect caused by cancer or by trauma, meaning an injury or physical harm.

Who cannot join the trial?

5 criteria

Allergy to indocyanine green, a dye used during the procedure to help check blood flow.
Allergy to iodine, a common substance found in some medicines and contrast dyes.
Severe liver impairment, meaning the liver is badly damaged and not working well.
Severe kidney impairment, meaning the kidneys are badly damaged and not working well.
Pregnancy.

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Region Skane Skanes Universitetssjukhus
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Lund, Sweden

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Investigated drugs

Indocyanine green is a dye given into a vein during surgery. In this trial, it is used to help the surgical team see blood flow in the flap with a special camera that detects fluorescence. The goal is to check whether the flap is getting enough blood during the operation, so the team can spot poor circulation early and decide if any surgical changes are needed to help prevent partial flap loss.

Indocyanine Green

What is already known about the treatment

Indocyanine green - Indocyanine green is given as a solution for injection into a vein, usually during surgery, and it is used with a special camera to help doctors see blood flow in real time. It is a well-known substance in medical practice and research, especially for checking circulation, liver function, and tissue blood supply; in this trial, it is used to assess flap perfusion in head and neck reconstruction. Its main effect is that it binds to proteins in the blood and then gives off near-infrared light when exposed to the right imaging system, which lets doctors see how well blood is reaching the tissue. It is classified as a diagnostic imaging agent and a dye used for medical imaging.

Investigated diseases

Head and Neck Cancer - Head and neck cancer is a group of cancers that begin in the tissues of the mouth, throat, voice box, nose, or nearby areas. It usually starts as an abnormal growth of cells that can slowly enlarge and spread into surrounding tissues. As it progresses, it may involve nearby structures and form more extensive disease in the head and neck region.