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
|Condition or disease||Intervention/treatment||Phase|
|Thyroid Cancer Thyroid Goiter Graves Disease||Drug: Indocyanine Green||Phase 4|
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 (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Experimental: Indocyanine Green||
Drug: Indocyanine Green
ICG is a fluorescent dye which binds tightly to plasma proteins and becomes confined to the vascular system.
- Quantification of the fluorescent signal of ICG [ Time Frame: At time of surgery ]Quantification of the fluorescent signal of ICG
- 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
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
|Contact: Jesse Pasternak, MD, MPHcfirstname.lastname@example.org|
|University Health Network||Recruiting|
|Toronto, Ontario, Canada, M5G 2C4|
|Contact: Jesse Pasternak, MD, MPHc 4163405195 email@example.com|
|Principal Investigator:||Jesse Pasternak, MD, MPHc||University Health Network, Toronto|