A trial using near-infrared florescence imaging during surgery to remove the thyroid (NIFTy)

Cancer type:

Thyroid cancer

Status:

Open

Phase:

Phase 2/3

This trial is looking at using near-infrared fluorescence imaging during thyroid surgery to avoid removing or damaging the parathyroid glands. 

It is open to people who are having all of their thyroid gland removed. It is also open for people who have had part of their  thyroid gland removed and are having surgery to remove the remaining lobe of their thyroid.

More about this trial

There are 4 parathyroid glands Open a glossary item. They are about the size of a grain of rice. They are on either side of the thyroid gland Open a glossary item.

During surgery to remove the thyroid surgeons might accidentally take out the parathyroid glands or damage them.

Their removal can lead to a condition called hypoparathyroidism Open a glossary item. This affects how much calcium there is in your body. Usually this is temporary. But for some people it can be a lifelong condition. And these people need lifelong care and medication. 

Researchers have developed a technique called near-infrared fluorescence imaging (NIRF). This involves using a medical dye called indocyanine green (ICG) and an infrared camera.  

Using ICG the parathyroid glands light up under the infrared light. During the operation the surgeon shines the infrared camera on the thyroid area. The parathyroid glands should glow. This helps the surgeons identify the glands and so minimises any damage to them. They can do this many times during the operation.

They inject the ICG dye towards the end of the operation and use the infrared camera again. They expect it to show the blood supply to the parathyroid gland because the blood vessels should glow green. This helps the surgeons determine if the glands still have a good blood supply. This  means the parathyroid glands should be okay.

The aim of this trial is to find out whether using NIRF can help reduce the number of people who have damage to their parathyroid glands after thyroid surgery.

Who can enter

The following bullet points are a summary of the entry conditions for this trial. Talk to your doctor or the trial team if you are unsure about any of these. They will be able to advise you. 

Who can take part

You may be able to join this trial if all of the following apply. You:

  • are to have surgery to remove the whole thyroid gland or to remove the remaining lobe of the thyroid
  • are willing and able to fulfil the requirements of the trial including filling in questionnaires
  • have satisfactory blood test results
  • are at least 18 years old

Who can’t take part

You cannot join this trial if any of these apply. You:

  • are having your parathyroid glands removed or you are having chest surgery at the same time as your thyroid surgery
  • are having thyroid surgery again. This is unless it is to remove the remaining lobe of the thyroid after previously having one lobe removed.
  • have had a blood test that shows there is too much or too little calcium in the blood. This is if the result was within 3 months of your planned thyroid surgery.
  • have a severe disease or diseases that affect the whole body. These can include heart problems Open a glossary item, lung problems Open a glossary item or other medical conditions.
  • are allergic or sensitive to the dye used in this trial. You also cannot join if you are allergic or sensitive to iodine or dyes containing iodine.
  • are taking calcium or active vitamin D supplements such as alfacalcidol or calcitrol. You also can’t take part if you are to have calcium and or vitamin D supplements before your surgery.
  • are pregnant

Trial design

This is a phase 2/3 trial. The team need 454 people to join. 

It is a randomised trial. A computer puts you into a treatment group. Neither you nor your doctor chooses which group you are in. 

Half of the people have surgery:

  • without the surgeon using near-infrared fluorescence
  • with the surgeon using near-infrared fluorescence

The operation you have is the same whether your surgeon uses near-infrared fluorescence or not. 

We have information about surgery for thyroid cancer.

Near-infrared fluorescence (NIRF) is a type of imaging that uses infrared light. 

You have a dye as an injection into a vein during surgery. The dye is indocyanine green (ICG).

When the surgeon shines infrared light onto the parathyroid glands they should glow. This helps the surgeons see the glands more clearly. After they give the dye the surgeon shines infrared light onto the parathyroid glands and it should help the surgeon see the blood vessels to the glands more clearly.

Quality of life
You fill in questionnaires when you join the trial. And then at 1 month and 6 months after your surgery. The questions ask about:

  • your general health
  • your wellbeing
  • how you are feeling in general
  • your particular condition

This is a quality of life questionnaire.

Hospital visits

There are no extra hospital visits if you join this trial.

Side effects

Surgeons routinely use the indocyanine green (ICG) dye to see blood flow during surgery. It is safe. However as with all medical dyes there is the possibility of an allergic reaction Open a glossary item

The surgeon and the team will monitor you closely during your surgery. 

We have information about thyroid surgery.

Location

London
Sheffield

Recruitment start:

Recruitment end:

How to join a clinical trial

Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Chief Investigator

Professor Saba Balasubramanian

Supported by

Clinical Trials Research Unit (CTRU), University of Leeds
Sheffield Teaching Hospitals NHS Foundation Trust 
NIHR Efficacy and Mechanism Evaluation (EME) Programme

Freephone 0808 800 4040

Last review date

CRUK internal database number:

17383

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Cara took part in a clinical trial

A picture of Cara

"I am glad that taking part in a trial might help others on their own cancer journey.”

Last reviewed:

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