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Diagnostic Accuracy Study of Indocyanine Green for Parathyroid Perfusion Assessment

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ClinicalTrials.gov Identifier: NCT03969108
Recruitment Status : Recruiting
First Posted : May 31, 2019
Last Update Posted : September 27, 2019
Sponsor:
Information provided by (Responsible Party):
University Health Network, Toronto

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
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
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2020


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.




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



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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03969108


Contacts
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Contact: Jesse Pasternak, MD, MPHc 4163405195 jesse.pasternak@uhn.ca

Locations
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Canada, Ontario
University Health Network Recruiting
Toronto, Ontario, Canada, M5G 2C4
Contact: Jesse Pasternak, MD, MPHc    4163405195    jesse.pasternak@uhn.ca   
Sponsors and Collaborators
University Health Network, Toronto
Investigators
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Principal Investigator: Jesse Pasternak, MD, MPHc University Health Network, Toronto

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Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT03969108     History of Changes
Other Study ID Numbers: 19-5447
First Posted: May 31, 2019    Key Record Dates
Last Update Posted: September 27, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by University Health Network, Toronto:
Thyroid surgery
Indocyanine green (ICG)
Hypoparathyroidism
Additional relevant MeSH terms:
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Graves Disease
Thyroid Diseases
Endocrine System Diseases
Orbital Diseases
Eye Diseases
Autoimmune Diseases
Immune System Diseases
Thyroid Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
Exophthalmos
Goiter
Hyperthyroidism
Parathyroid Hormone
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs