Clinical trial NCT06579430: Diagnostic Accuracy Study of Indocyanine Green for Perfusion Assessment
Official title: Diagnostic Accuracy Study of Indocyanine Green for Perfusion Assessment
Conditions: Hypoparathyroidism
Summary: Background Near-infrared fluorescence guided surgery with indocyanine green (ICG) was introduced for parathyroid perfusion assessment during total thyroidectomy in 2016. ICG can visualize tissue perfusion, since it becomes completely and permanently fixed to plasma proteins in the bloodstream, and circulates in the intravascular compartment only. ICG was already approved in 1956 for clinical use of tissue perfusion. However, until now there is still no (parathyroid) universal standard imaging protocol for ICG-guided fluorescent surgery including quantitative evaluation.
Main research question To develop a standardized universal imaging protocol for the assessment of parathyroid perfusion during total thyroidectomy with ICG including quantitative evaluation of the fluorescent signal.
• Design (including population, confounders/outcomes) This will be a proof-of-concept, prospective cohort study of patients undergoing an ICG-guided fluorescent total thyroidectomy to evaluate parathyroid gland perfusion. The main study endpoint is quantification of the fluorescent signal of ICG stratified by the occurrence of hypoparathyroidism. Hypoparathyroidism will be defined as a decrease in PTH of >70% at the first postoperative day. Furthermore, we will calculate the sensitivity of our model for the prediction of hypoparathyroidism.
Secondary outcomes are data from surgery, pre- and postoperative lab values (including calcium, PTH, albumin) and postoperative medication use.
Expected results We expect that the results of this study will lead to the development of a universal standard imaging protocol for ICG-guided fluorescent total thyroidectomy.
Interventions:
description: ICG-NIRF was performed using the Quest Spectrum Platform 2.0. The camera lens was positioned at a fixed distance of 30 cm to the wound bed, at a perpendicular angle, with the gain set at 22.5 decibels (dB) and an exposure time of 50 milliseconds (ms). ICG was dissolved in sterile water at a concentration of 2.5 mg/mL as recommended by the manufacturer (Verdye). 1.5 mg of ICG per liter of circulating blood volume was then administered through manual bolus intravenous injection. Blood volume estimation was based on the patient&amp;#39;s height and weight.
name: Indocyanine Green near infrared fluorescence imaging
other_name: Multicenter cohort
type: Drug
description: ICG-NIRF was performed using the Quest Spectrum Platform 2.0. The camera lens was positioned at a fixed distance of 30 cm to the wound bed, at a perpendicular angle, with the gain set at 22.5 decibels (dB) and an exposure time of 50 milliseconds (ms). ICG was dissolved in sterile water at a concentration of 0.5 or 2.5 mg/mL as recommended by the manufacturer. 1.5 mg of ICG per liter of circulating blood volume was then administered through manual bolus intravenous injection. Blood volume estimation was based on the patients height and weight. Different administration rates (fast: 2s, slow: 15-20s) and a different camera system were tested.<br/>Group 1: Quest Platform 2.0; Fast/Slow; 2.5 mg/mL Group 2: Quest Platform 2.0; Slow/Fast; 2.5 mg/mL Group 3: Quest Platform 2.0; Fast/Fast; 2.5 mg/mL Group 4: Stryker Spy-Elite; Fast/Fast; 2.5 mg/mL Group 5: Quest Platform 2.0; Fast/Fast; 0.5 mg/mL
name: Indocyanine Green near infrared fluorescence imaging
other_name: Root cause analysis
type: Drug
Study arms:
design_group_description: Patients undergoing total thyroidectomy are included in this arm. Patients are included in the University Medical Center Groningen and the Erasmus Medical Center Rotterdam. After total thyroidectomy, the perfusion in the parathyroid glands is imaged utilizing ICG-NIRF. Postoperatively; perfusion curves are drawn for each parathyroid gland. Perfusion parameters are compared between patients and correlated to postoperative parathyroid function (PTH).
design_group_title: Multicenter cohort
design_group_type: Experimental
design_group_description: Patients undergoing total or hemi-thyroidectomy are included in this arm. Patients are included in the University Medical Center Groningen. After (total/hemi)thyroidectomy, the perfusion in the parathyroid glands is imaged utilizing ICG-NIRF. A second measurement is performed in order to compare the influence of injection speed, camera and ICG dose on the curves. Postoperatively; perfusion curves are drawn for each parathyroid gland. Perfusion parameters are compared between the two measurements in the same patient.
design_group_title: Root cause analysis
design_group_type: Experimental
Sponsor: Universitair Medisch Centrum Groningen
Collaborators: Erasmus Medical Center (Private Equity)
Leids Universitair Medisch Centrum
Drug name mappings:
name: 吲哚菁绿
lang: CN
name: Indocyanine Green
lang: EN
name: インドシアニングリーン
lang: JP