Diagnostic Accuracy Study of Indocyanine Green for Parathyroid Perfusion Assessment

Phase 4

Completed

• Conditions: Thyroid Cancer; Thyroid Goiter; Graves Disease
• Interventions: Drug: Indocyanine Green

• Registration Number: NCT03969108
• Lead Sponsor: University Health Network, Toronto

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2019-05-24
• Study First Submitted QC: 2019-05-28
• Study First Posted: 2019-05-31
• Study Start: 2019-08-06
• Primary Completion: 2019-11-12
• Study Completion: 2019-11-13
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-26
• Last Update Posted: 2020-03-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

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

Exclusion Criteria

1. Patients with a known allergy to ICG or iodinated contrast
2. Pregnant or lactating women
3. Patients with previous neck surgery

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Indocyanine Green	Indocyanine Green	-

Primary Outcome Measures

Name	Time	Method
Quantification of the fluorescent signal of ICG	At time of surgery	Quantification of the fluorescent signal of ICG

Secondary Outcome Measures

Name	Time	Method
Postoperative calcium concentration	Postoperative day 1 and at the first out-patient clinic visit (between 2 to 30 days postoperative)	Postoperative albumin-corrected calcium concentration in blood
Duration of surgery	From start to end of surgery	Duration of surgery in minutes
Appearance of parathyroid gland	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)
Postoperative PTH concentration	Postoperative day 1 and at the first out-patient clinic visit (between 2 to 30 days postoperative)	Postoperative PTH concentration in blood
Rate of prescribed postoperative calcium medication	Postoperative day 1 and at the first out-patient clinic visit (between 2 to 30 days postoperative)	Rate of prescribed postoperative calcium medication
Rate of prescribed postoperative vitamin D medication	Postoperative day 1 and at the first out-patient clinic visit (between 2 to 30 days postoperative)	Rate of prescribed postoperative vitamin D medication

Trial Locations

Locations (1)

University Health Network; 🇨🇦 Toronto, Ontario, Canada