Diagnostic Accuracy Study of Indocyanine Green for Parathyroid Perfusion Assessment
Primary Purpose
Thyroid Cancer, Thyroid Goiter, Graves Disease
Status
Completed
Phase
Phase 4
Locations
Canada
Study Type
Interventional
Intervention
Indocyanine Green
Sponsored by
About this trial
This is an interventional other trial for Thyroid Cancer focused on measuring Thyroid surgery, Indocyanine green (ICG), Hypoparathyroidism
Eligibility Criteria
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
Sites / Locations
- University Health Network
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Indocyanine Green
Arm Description
Outcomes
Primary Outcome Measures
Quantification of the fluorescent signal of ICG
Quantification of the fluorescent signal of ICG
Secondary Outcome Measures
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)
Duration of surgery
Duration of surgery in minutes
Postoperative calcium concentration
Postoperative albumin-corrected calcium concentration in blood
Postoperative PTH concentration
Postoperative PTH concentration in blood
Rate of prescribed postoperative calcium medication
Rate of prescribed postoperative calcium medication
Rate of prescribed postoperative vitamin D medication
Rate of prescribed postoperative vitamin D medication
Full Information
NCT ID
NCT03969108
First Posted
May 24, 2019
Last Updated
March 26, 2020
Sponsor
University Health Network, Toronto
1. Study Identification
Unique Protocol Identification Number
NCT03969108
Brief Title
Diagnostic Accuracy Study of Indocyanine Green for Parathyroid Perfusion Assessment
Official Title
Diagnostic Accuracy Study of Indocyanine Green for Parathyroid Perfusion Assessment
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
August 6, 2019 (Actual)
Primary Completion Date
November 12, 2019 (Actual)
Study Completion Date
November 13, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Health Network, Toronto
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thyroid Cancer, Thyroid Goiter, Graves Disease
Keywords
Thyroid surgery, Indocyanine green (ICG), Hypoparathyroidism
7. Study Design
Primary Purpose
Other
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Indocyanine Green
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Indocyanine Green
Intervention Description
ICG is a fluorescent dye which binds tightly to plasma proteins and becomes confined to the vascular system.
Primary Outcome Measure Information:
Title
Quantification of the fluorescent signal of ICG
Description
Quantification of the fluorescent signal of ICG
Time Frame
At time of surgery
Secondary Outcome Measure Information:
Title
Appearance of parathyroid gland
Description
Vascularization appearance of parathyroid gland intraoperatively (1= surgeon thinks parathyroid gland is well vascularized, 2 = surgeons thinks parathyroid gland is devascularized)
Time Frame
At time of surgery
Title
Duration of surgery
Description
Duration of surgery in minutes
Time Frame
From start to end of surgery
Title
Postoperative calcium concentration
Description
Postoperative albumin-corrected calcium concentration in blood
Time Frame
Postoperative day 1 and at the first out-patient clinic visit (between 2 to 30 days postoperative)
Title
Postoperative PTH concentration
Description
Postoperative PTH concentration in blood
Time Frame
Postoperative day 1 and at the first out-patient clinic visit (between 2 to 30 days postoperative)
Title
Rate of prescribed postoperative calcium medication
Description
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)
Title
Rate of prescribed postoperative vitamin D medication
Description
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)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jesse Pasternak, MD, MPHc
Organizational Affiliation
University Health Network, Toronto
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Health Network
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2C4
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
No
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Diagnostic Accuracy Study of Indocyanine Green for Parathyroid Perfusion Assessment
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