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Completed

NCT Number: NCT03969108

Diagnostic Accuracy Study of Indocyanine Green for Parathyroid Perfusion Assessment

This study aims to develop a standardized universal imaging protocol for ICG-guided fluorescent total thyroidectomy, including quantitative evaluations of the fluorescent signal. Therefore, patients will undergo thyroid surgery (total thyroidectomy) with the use of ICG fluorescence.

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Key information

Conditions

Thyroid Cancer Autoimmune Diseases Endocrine Gland Neoplasms Endocrine System Diseases Exophthalmos Eye Diseases Goiter Graves Disease Head and Neck Neoplasms Hyperthyroidism Hypoparathyroidism Immune System Diseases Neoplasms Neoplasms by Site Orbital Diseases Parathyroid Diseases Thyroid Diseases Thyroid Goiter Thyroid Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University Health Network

Toronto, Ontario, M5G 2C4, Canada

About this study

Background Thyroid surgery volume continues to increase worldwide over the past few decades. During a total thyroidectomy (TTx), the ultimate goal is to remove all thyroid tissue, whereas damage to adjacent tissue is prevented. However, iatrogenic hypoparathyroidism, as a result of surgical removal or damage to the parathyroid glands, occurs in approximately 30% of the cases. In 2016 near-infrared fluorescence guided surgery with indocyanine green (ICG) was proposed for visualizing viability and blood supply of parathyroid glands during TTx. ICG can visualize tissue perfusion, since it becomes completely and permanently fixed to plasma proteins once in the bloodstream, and circulates in the intravascular compartment only. However, one of the limitations of ICG imaging is the subjectivity of the interpretation of fluorescence, which makes the assessment of images inconsistent among studies. There is a clear need for standardization of the evaluation of the perfusion with ICG, since visual evaluation of the fluorescent signal of ICG is not sufficient to reliably predict the perfusion of parathyroid glands.

Main research question To develop a standardized universal imaging protocol for ICG-guided fluorescent total thyroidectomy including quantitative evaluations of the fluorescent signal.

Design This will be a proof-of-concept , prospective cohort study of patients undergoing a total thyroidectomy with ICG-guided fluorescent surgery to evaluate tissue perfusion The main study endpoint is quantification of the fluorescent signal of ICG. Secondary outcomes are data from surgery, postoperative lab values (including calcium, PTH, albumin) and postoperative medication use.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients ≥ 18 years
  • Patients undergoing total thyroidectomy as surgical procedure for thyroid cancer, Graves' disease or goiter
  • Patients are eligible for surgery
  • Patients are mentally competent and are able and willing to comply with study procedures
  • Written informed consent

Exclusion criteria

  • Patients with a known allergy to ICG or iodinated contrast
  • Pregnant or lactating women
  • Patients with previous neck surgery

Treatment and study plan

Indocyanine green

Drug

ICG is a fluorescent dye which binds tightly to plasma proteins and becomes confined to the vascular system.

Primary outcomes

  1. Quantification of the fluorescent signal of ICG

    Time frame: At time of surgery

    Quantification of the fluorescent signal of ICG

Secondary outcomes

  1. Appearance of parathyroid gland

    Time frame: At time of surgery

    Vascularization appearance of parathyroid gland intraoperatively (1= surgeon thinks parathyroid gland is well vascularized, 2 = surgeons thinks parathyroid gland is devascularized)

  2. Duration of surgery

    Time frame: From start to end of surgery

    Duration of surgery in minutes

  3. Postoperative calcium concentration

    Time frame: Postoperative day 1 and at the first out-patient clinic visit (between 2 to 30 days postoperative)

    Postoperative albumin-corrected calcium concentration in blood

  4. Postoperative PTH concentration

    Time frame: Postoperative day 1 and at the first out-patient clinic visit (between 2 to 30 days postoperative)

    Postoperative PTH concentration in blood

  5. Rate of prescribed postoperative calcium medication

    Time frame: Postoperative day 1 and at the first out-patient clinic visit (between 2 to 30 days postoperative)

    Rate of prescribed postoperative calcium medication

  6. Rate of prescribed postoperative vitamin D medication

    Time frame: Postoperative day 1 and at the first out-patient clinic visit (between 2 to 30 days postoperative)

    Rate of prescribed postoperative vitamin D medication

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Registry information

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
May 31, 2019
Registry last updated
Mar 27, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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