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Study of Indocyanine Green Angiography to Prevent Hypoparathyroidism in Patients Undergoing Total Thyroid Removal

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What is this trial about?

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

This clinical trial studies the use of indocyanine green during total thyroidectomy (complete removal of the thyroid gland) to help prevent hypoparathyroidism and hypocalcemia. Hypoparathyroidism is a condition where the body doesn't produce enough parathyroid hormone, which can lead to low blood calcium levels after thyroid surgery. Hypocalcemia occurs when calcium levels in the blood become too low, which can cause various symptoms.

The study aims to determine if using indocyanine green, a special dye that helps surgeons see blood vessels and tissues more clearly during surgery, can reduce the occurrence of low calcium levels after thyroid surgery. During the procedure, some patients will receive an injection of indocyanine green at a dose of up to 0.5 milligrams per kilogram of body weight, while others will undergo standard surgery without the dye.

The study will monitor patients' calcium levels in their blood for up to 6 months after surgery. Doctors will check how well the parathyroid glands are working and whether patients develop any signs of low calcium levels. They will also track if using the dye helps surgeons better identify and preserve important structures during the operation.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial surgery preparation

    You will be scheduled for a total thyroidectomy (complete removal of thyroid gland).

    Before the surgery, your medical team will determine if you will receive indocyanine green imaging during the procedure.

  2. Step 2

    Surgery day

    If you are in the treatment group, you will receive INFRACYANINE (25 mg/10 mL) as an injection during surgery.

    The surgical team will use special imaging to monitor your parathyroid glands (small glands near the thyroid) and their blood supply.

    The entire thyroid gland will be removed during the procedure.

  3. Step 3

    First 48 hours after surgery

    Your blood calcium levels will be monitored regularly.

    Medical staff will check for signs of hypocalcemia (low blood calcium levels of 2 mmol/L or less).

    You will be monitored for any reactions to the surgical procedure or medications used.

  4. Step 4

    Follow-up period

    Your calcium levels will be checked at day 8 after surgery.

    Additional follow-up appointments will occur at 1 month and 6 months after surgery.

    During each visit, your blood calcium levels and parathyroid hormone levels will be measured.

    Medical staff will monitor for any ongoing signs of low calcium or parathyroid issues.

Who can join the trial?

7 criteria

  • You must be an adult (18 years or older)
  • You must need a total thyroidectomy (complete surgical removal of the thyroid gland)
  • You must sign an informed consent form agreeing to participate in the study
  • You must be covered by a social security scheme (have active health insurance coverage)
  • You can be either male or female
  • You must be able to understand and agree to the study procedures
  • You must not be part of a vulnerable population (such as prisoners or persons unable to give consent)

Who cannot join the trial?

12 criteria

  • Age below 18 or above 65 years
  • Previous surgery on the thyroid gland (operation on the thyroid)
  • Known hypocalcemia (low blood calcium levels) before surgery
  • Allergic reaction to indocyanine green (the dye used in the study)
  • Pregnancy or breastfeeding
  • Current participation in other clinical trials
  • Unable to provide informed consent
  • Known kidney disease (as it may affect calcium levels)
  • Taking medications that affect calcium levels in the blood
  • History of parathyroid gland disorders (small glands near the thyroid that control calcium)
  • Serious heart, liver, or blood disorders
  • Mental conditions that may affect ability to follow study procedures
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Investigated drugs

Indocyanine green (ICG) is a medical dye that helps surgeons see blood vessels and tissues more clearly during surgery. In this trial, it is used to help identify parathyroid glands during thyroid surgery. The dye is injected into the bloodstream and glows under special infrared light, making it easier for surgeons to locate and preserve the parathyroid glands, which are important for maintaining normal calcium levels in the body. Albumin is a protein naturally present in the blood that helps transport calcium. While not a medication itself, blood albumin levels are measured to correctly interpret calcium levels in patients undergoing thyroid surgery. The trial compares surgical outcomes between patients who receive ICG imaging during surgery and those who undergo standard thyroid surgery without ICG assistance.

What is already known about the treatment

Indocyanine Green (ICG) - A diagnostic dye administered intravenously that is used for fluorescence angiography to visualize blood vessels and tissue perfusion during surgical procedures. This FDA-approved contrast agent is particularly valuable in thyroid surgery for identifying and preserving parathyroid glands, helping to prevent post-surgical hypoparathyroidism and hypocalcemia. ICG works by binding to plasma proteins and fluorescing when exposed to near-infrared light, allowing surgeons to see real-time blood flow patterns in the parathyroid glands. It belongs to the class of fluorescent imaging agents and has a well-established safety profile with rapid clearance from the body through hepatic excretion.

Investigated diseases

  • Hypocalcemia

    A condition where calcium levels in the blood become too low. The body needs calcium for proper nerve, muscle, and heart function. It can develop gradually or suddenly, causing symptoms like muscle spasms, numbness in fingers and toes, and tingling sensations. The condition can affect various body systems and may be temporary or ongoing.

  • Hypoparathyroidism

    A disorder where the parathyroid glands don't produce enough parathyroid hormone. This hormone helps control calcium levels in the blood and bones. The condition leads to low calcium levels and can occur after neck surgery or due to other medical conditions. It affects how the body manages calcium and phosphorus balance.

  • Thyroid Disease

    A group of conditions affecting the thyroid gland, which produces hormones that regulate metabolism, growth, and body temperature. These disorders can cause the thyroid to make too much or too little thyroid hormone. The condition can affect many body functions and may develop slowly over time.

Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-516255-41-00Protocol code29BRC20.0208Estimated enrolment242 patientsSponsorCentre Hospitalier Regional Et Universitaire De Brest

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