Clinical trial NCT06579430: Diagnostic Accuracy Study of Indocyanine Green for Perfusion Assessment
Official title: Diagnostic Accuracy Study of Indocyanine Green for Perfusion Assessment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Hypoparathyroidism
Lead sponsor: University Medical Center Groningen
Sponsor class: OTHER
Collaborators: name: Erasmus Medical Center
name: Leiden University Medical Center
First posted: 2024-08-30
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: DIAGNOSTIC

Brief 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 \&gt;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.


Eligibility criteria: Inclusion Criteria:

1. Age \&gt;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

Primary outcomes:
measure: Injection speed
timeFrame: During surgery
measure: ICG concentration
timeFrame: During surgery
measure: Camera system
timeFrame: During surgery
Secondary outcomes:
measure: Multicenter application
timeFrame: From surgery until one day post-surgery
Other outcomes:
Locations:
city: Groningen
country: Netherlands
facility: University Medical Center Groningen
city: Rotterdam
country: Netherlands
facility: Erasmus Medical Center Rotterdam
Study officials:
affiliation: UMCG
name: Schelto Kruijff, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Noltes ME, Metman MJH, Jansen L, Peeperkorn EWM, Engelsman AF, Kruijff S. Parathyroid Function Saving Total Thyroidectomy Using Autofluorescence and Quantified Indocyanine Green Angiography. VideoEndocrinology. 2021 Jun 10;8(2):ve.2021.0008. doi: 10.1089/ve.2021.0008. eCollection 2021.
citation: Noltes ME, Metman MJH, Heeman W, Rotstein L, van Ginhoven TM, Vriens MR, Engelsman AF, Boerma EC, Brouwers AH, van Dam GM, Pasternak JD, Kruijff S. A Novel and Generic Workflow of Indocyanine Green Perfusion Assessment Integrating Standardization and Quantification Toward Clinical Implementation. Ann Surg. 2021 Dec 1;274(6):e659-e663. doi: 10.1097/SLA.0000000000004978.