Diagnostic Accuracy Study of Indocyanine Green for Parathyroid Perfusion Assessment

Thyroid Cancer Clinical Trial

Official title:

Diagnostic Accuracy Study of Indocyanine Green for Parathyroid Perfusion Assessment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03969108
• Other study ID #: 19-5447
• Status: Completed
• Phase: Phase 4
• Start date: August 6, 2019
• Est. completion date: November 13, 2019

Study information

• Verified date: March 2020
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: November 13, 2019
• Est. primary completion date: November 12, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Graves Disease
• Thyroid Cancer
• Thyroid Diseases
• Thyroid Goiter
• Thyroid Neoplasms

Intervention

Drug:
• Indocyanine Green
ICG is a fluorescent dye which binds tightly to plasma proteins and becomes confined to the vascular system.

Locations

Country	Name	City	State
Canada	University Health Network	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quantification of the fluorescent signal of ICG	Quantification of the fluorescent signal of ICG	At time of surgery
Secondary	Appearance of parathyroid gland	Vascularization appearance of parathyroid gland intraoperatively (1= surgeon thinks parathyroid gland is well vascularized, 2 = surgeons thinks parathyroid gland is devascularized)	At time of surgery
Secondary	Duration of surgery	Duration of surgery in minutes	From start to end of surgery
Secondary	Postoperative calcium concentration	Postoperative albumin-corrected calcium concentration in blood	Postoperative day 1 and at the first out-patient clinic visit (between 2 to 30 days postoperative)
Secondary	Postoperative PTH concentration	Postoperative PTH concentration in blood	Postoperative day 1 and at the first out-patient clinic visit (between 2 to 30 days postoperative)
Secondary	Rate of prescribed postoperative calcium medication	Rate of prescribed postoperative calcium medication	Postoperative day 1 and at the first out-patient clinic visit (between 2 to 30 days postoperative)
Secondary	Rate of prescribed postoperative vitamin D 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)