Diagnostic Accuracy Study of Indocyanine Green for Parathyroid Perfusion Assessment

Sponsor

University Health Network, Toronto (Other)

Overall Status

Completed

CT.gov ID

NCT03969108

Collaborator

(none)

Enrollment

Location

Arm

3.3

Actual Duration (Months)

3.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Thyroid Cancer Thyroid Goiter Graves Disease	Drug: Indocyanine Green	Phase 4

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 Design

Study Type:

Interventional

Actual Enrollment :

10 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

Diagnostic Accuracy Study of Indocyanine Green for Parathyroid Perfusion Assessment

Actual Study Start Date :

Aug 6, 2019

Actual Primary Completion Date :

Nov 12, 2019

Actual Study Completion Date :

Nov 13, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Indocyanine Green	Drug: Indocyanine Green ICG is a fluorescent dye which binds tightly to plasma proteins and becomes confined to the vascular system.

Arm

Intervention/Treatment

Experimental: Indocyanine Green

Drug: Indocyanine Green

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

Outcome Measures

Primary Outcome Measures

Quantification of the fluorescent signal of ICG [At time of surgery]
Quantification of the fluorescent signal of ICG

Secondary Outcome Measures

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)
Duration of surgery [From start to end of surgery]
Duration of surgery in minutes
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
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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