Diagnostic Accuracy Study of Indocyanine Green for Parathyroid Perfusion Assessment

March 26, 2020 updated by: University Health Network, Toronto
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

10

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G 2C4
        • University Health Network

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quantification of the fluorescent signal of ICG
Time Frame: At time of surgery
Quantification of the fluorescent signal of ICG
At time of surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
At time of surgery
Duration of surgery
Time Frame: From start to end of surgery
Duration of surgery in minutes
From start to end of surgery
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
Postoperative day 1 and at the first out-patient clinic visit (between 2 to 30 days postoperative)
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
Postoperative day 1 and at the first out-patient clinic visit (between 2 to 30 days postoperative)
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
Postoperative day 1 and at the first out-patient clinic visit (between 2 to 30 days postoperative)
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
Postoperative day 1 and at the first out-patient clinic visit (between 2 to 30 days postoperative)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Health Network, Toronto

Investigators

  • Principal Investigator: Jesse Pasternak, MD, MPHc, University Health Network, Toronto

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 6, 2019

Primary Completion (Actual)

November 12, 2019

Study Completion (Actual)

November 13, 2019

Study Registration Dates

First Submitted

May 24, 2019

First Submitted That Met QC Criteria

May 28, 2019

First Posted (Actual)

May 31, 2019

Study Record Updates

Last Update Posted (Actual)

March 27, 2020

Last Update Submitted That Met QC Criteria

March 26, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 19-5447

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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