Diagnostic Accuracy Study of Indocyanine Green for Perfusion Assessment

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-05

Study Completion Date

2024-05-02

Brief Summary

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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.

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Detailed Description

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Conditions

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Hypoparathyroidism

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

A multicenter study is being conducted using standardized ICG-NIRF imaging of the parathyroid glands following total thyroidectomy. Perfusion curves are generated and analyzed postoperatively, with flow parameters being linked to postoperative parathyroid function.

The study consists of two groups: the first group includes patients undergoing total thyroidectomy, where perfusion curves are compared between different patients. The second, smaller group is part of a root cause analysis, where the effects of injection speed and ICG concentration on the reproducibility of perfusion curves are evaluated by comparing curves within the same patient.

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Multicenter cohort

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).

Group Type EXPERIMENTAL

Indocyanine Green near infrared fluorescence imaging

Intervention Type DRUG

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\&#39;s height and weight.

Root cause analysis

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.

Group Type EXPERIMENTAL

Indocyanine Green near infrared fluorescence imaging

Intervention Type DRUG

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.

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

Interventions

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Indocyanine Green near infrared fluorescence imaging

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\&#39;s height and weight.

Intervention Type DRUG

Indocyanine Green near infrared fluorescence imaging

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.

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

Intervention Type DRUG

Other Intervention Names

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Multicenter cohort Root cause analysis

Eligibility Criteria

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Inclusion Criteria

1. Age \>18 years
2. Patients undergoing ICG-guided total thyroidectomy as surgical procedure for thyroid cancer, Graves' disease or goiter
3. Patients are eligible for surgery
4. Patients are mentally competent
5. Written informed consent

Exclusion Criteria

1. Patients with known allergy for ICG or iodinated contrast
2. Pregnant or lactating women
3. Patients with previous neck surgery
4. Patients with dialysis dependent renal failure and kidney transplant

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No