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出境医 / 临床实验 / Diagnostic Accuracy Study of Indocyanine Green for Parathyroid Perfusion Assessment

Diagnostic Accuracy Study of Indocyanine Green for Parathyroid Perfusion Assessment

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
Layout table for study information
Study Type : Interventional  (Clinical Trial)
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 : August 6, 2019
Actual Primary Completion Date : November 12, 2019
Actual Study Completion Date : November 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.
Outcome Measures
Primary Outcome Measures :
  1. Quantification of the fluorescent signal of ICG [ Time Frame: At time of surgery ]
    Quantification of the fluorescent signal of ICG


Secondary Outcome Measures :
  1. 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)

  2. Duration of surgery [ Time Frame: From start to end of surgery ]
    Duration of surgery in minutes

  3. 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

  4. 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

  5. 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

  6. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

Locations
Layout table for location information
Canada, Ontario
University Health Network
Toronto, Ontario, Canada, M5G 2C4
Sponsors and Collaborators
University Health Network, Toronto
Investigators
Layout table for investigator information
Principal Investigator: Jesse Pasternak, MD, MPHc University Health Network, Toronto
Tracking Information
First Submitted Date  ICMJE May 24, 2019
First Posted Date  ICMJE May 31, 2019
Last Update Posted Date March 27, 2020
Actual Study Start Date  ICMJE August 6, 2019
Actual Primary Completion Date November 12, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 28, 2019) 		Quantification of the fluorescent signal of ICG [ Time Frame: At time of surgery ]
Quantification of the fluorescent signal of ICG
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 30, 2019)
  • 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)
  • Duration of surgery [ Time Frame: From start to end of surgery ]
    Duration of surgery in minutes
  • 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 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
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: May 28, 2019)
  • 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)
  • Duration of surgery [ Time Frame: From start to end of surgery ]
    Duration of surgery in minutes
  • Postoperative calcium [ Time Frame: Postoperative day 1 and at the first out-patient clinic visit (between 2 to 30 days postoperative) ]
    Postoperative calcium
  • Postoperative albumin [ Time Frame: Postoperative day 1 and at the first out-patient clinic visit (between 2 to 30 days postoperative) ]
    Postoperative albumin
  • Postoperative PTH [ Time Frame: Postoperative day 1 and at the first out-patient clinic visit (between 2 to 30 days postoperative) ]
    Postoperative PTH
  • Postoperative calcium medication [ Time Frame: Postoperative day 1 and at the first out-patient clinic visit (between 2 to 30 days postoperative) ]
    Postoperative calcium medication
  • Postoperative vitamin D medication [ Time Frame: Postoperative day 1 and at the first out-patient clinic visit (between 2 to 30 days postoperative) ]
    Postoperative vitamin D medication
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Diagnostic Accuracy Study of Indocyanine Green for Parathyroid Perfusion Assessment
Official Title  ICMJE Diagnostic Accuracy Study of Indocyanine Green for Parathyroid Perfusion Assessment
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE
  • Thyroid Cancer
  • Thyroid Goiter
  • Graves Disease
Intervention  ICMJE Drug: Indocyanine Green
ICG is a fluorescent dye which binds tightly to plasma proteins and becomes confined to the vascular system.
Study Arms  ICMJE Experimental: Indocyanine Green
Intervention: Drug: Indocyanine Green
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 26, 2020) 		10
Original Estimated Enrollment  ICMJE
 (submitted: May 28, 2019) 		20
Actual Study Completion Date  ICMJE November 13, 2019
Actual Primary Completion Date November 12, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03969108
Other Study ID Numbers  ICMJE 19-5447
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party University Health Network, Toronto
Study Sponsor  ICMJE University Health Network, Toronto
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jesse Pasternak, MD, MPHc University Health Network, Toronto
PRS Account University Health Network, Toronto
Verification Date March 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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