A Phase 4 interventional study of Indocyanine Green in Thyroid Cancer, Thyroid Goiter and Graves Disease, sponsored by University Health Network, Toronto. Completed at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-03-27.
Sponsored by University Health Network, Toronto · Phase 4, Interventional, and Other
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.
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.
785 studies on the registry are indexed under Thyroid Neoplasms; 204 are open to participants now.
This study's enrollment of 10 is below the median of 53 across 520 interventional studies indexed under Thyroid Neoplasms.
Browse Thyroid Neoplasms studies →University Health Network, Toronto is the lead sponsor of 1,438 studies on the registry; 297 are open to participants now.
Of its 17 completed or terminated interventional studies of FDA-regulated products, 3 (18%) have results posted.
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You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Quantification of the fluorescent signal of ICG
Time frame: At time of surgery
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)
Time frame: At time of surgery
Duration of surgery
Duration of surgery in minutes
Time frame: From start to end of surgery
Postoperative calcium concentration
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)
Postoperative PTH concentration
Postoperative PTH concentration in blood
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 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 vitamin D 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)
Plan to share: No
No publications or documents are linked to this record.
Ran from Aug 2019 to primary completion in Nov 2019, 3 months.
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This study is completed, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Indocyanine Green
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