AuthorisedTherapeutic confirmatory (Phase III)Interventional

Contribution of ICG Angiography in the Detection of Parathyroids and the Prevention of Hypoparathyroidism Post Total Thyroidectomy (HYPOCAAVI)

This research study, named HYPOCAAVI, is exploring if using a special dye called indocyanine green (ICG) can improve thyroid surgery. Thyroid surgery sometimes affects small glands nearby, called parathyroids, which control calcium levels. If these glands are accidentally damaged or removed, calcium levels can drop too low (hypoparathyroidism or hypocalcaemia), causing various symptoms. Surgeons will inject the ICG dye, which glows under a special light, to help them see the parathyroid glands more clearly during the operation. The main aim is to see if finding these glands better helps prevent low calcium levels in the first 48 hours after surgery. The study also checks calcium levels over six months and looks for any side effects from the dye. This is a Phase III study, which means it's one of the final stages of testing to confirm if this new approach is effective and safe.

At a glance

Status

Authorised

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Centre Hospitalier Regional Et Universitaire De Brest

Enrolment target

242

Start

31 Jul 2024

Thyroid Diseases Hypoparathyroidism Hypocalcemia

What is this study about?

When someone needs their thyroid gland removed, surgeons try very hard to protect tiny glands nearby called parathyroid glands. These parathyroid glands are essential because they make a hormone that controls the amount of calcium in your blood. If these glands are accidentally damaged or not working well after surgery, your calcium levels can drop too low. This condition, called hypoparathyroidism or hypocalcaemia, can cause problems like muscle cramps, tingling, and feeling tired.

This study is looking at a new way to help surgeons see these important parathyroid glands better during surgery. They will use a special dye called indocyanine green (ICG). When this dye is injected, it glows under a special camera, making the parathyroid glands stand out. The idea is that if surgeons can see the parathyroid glands and their blood supply more clearly, they might be able to avoid damaging them, reducing the risk of low calcium levels after surgery.

The main goal of this study is to see if using this dye helps prevent low calcium levels in the first two days after thyroid surgery. They will also keep an eye on calcium levels for up to six months and check if the dye itself causes any problems. This research is important because it could lead to safer thyroid operations with fewer side effects for patients.

Key takeaways

The study uses a special dye to help surgeons see parathyroid glands better during thyroid surgery.
The main goal is to prevent low calcium levels after surgery.
It involves regular checks of your calcium levels for up to 6 months.
Participants will have a total thyroidectomy for thyroid disease.
This research aims to improve the safety and outcomes of thyroid surgery for future patients.

Who may be eligible?

To join this study, people must be at least 18 years old. The study is open to both men and women who are having their entire thyroid gland removed, a procedure known as a total thyroidectomy.

Patients would typically need to be in good general health, aside from the reasons they are having thyroid surgery, and be able to understand and agree to take part in the study. Your doctor will carefully review your medical history to make sure that taking part in this study is safe and appropriate for you.

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.

Are you 18 years old or older?
Are you having your entire thyroid gland removed (total thyroidectomy)?
Are you able to agree to take part in a research study?
Are you generally in good health other than your thyroid condition?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will have the special indocyanine green (ICG) dye injected during your thyroid surgery. Surgeons will use a special camera to observe how the dye highlights your parathyroid glands. After your surgery, doctors will regularly check your blood calcium levels, especially in the first 48 hours, and then again at 8 days, 1 month, and 6 months post-surgery. You will also be monitored for any side effects from the dye. The total duration of your participation, including follow-up, will be around 6 months.

Potential risks and benefits

Taking part in a clinical trial offers potential benefits, such as contributing to medical knowledge that could improve future surgical outcomes for others, and potentially receiving cutting-edge procedures or close monitoring of your health. However, there are also potential risks. The indocyanine green dye is generally safe, but like any medication, it could cause an allergic reaction in a small number of people. While the aim is to reduce complications, there's no guarantee that participating will prevent low calcium levels. You always have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
France

Common questions

What are parathyroid glands?

They are tiny glands near your thyroid that control your body's calcium levels, which are important for strong bones and proper muscle and nerve function.

What is hypocalcaemia?

This is when the calcium levels in your blood are too low, which can cause symptoms like tingling, muscle cramps, and tiredness.

What is indocyanine green (ICG)?

It's a special dye that glows under a specific light, helping surgeons see certain body parts, like the parathyroid glands, more clearly.

Will ICG make my surgery different?

The ICG is injected during surgery to help the surgeon see the parathyroid glands better, potentially changing how they approach identifying and preserving these glands, but the core surgery remains the same.

How long will the study follow me?

You will be followed for about 6 months after your surgery to check your calcium levels and overall well-being.