Diagnostic Accuracy Study of Indocyanine Green for Perfusion Assessment (Pre-CLOVER)

University Medical Center Groningen (UMCG)

Status and phase: Completed; Early Phase 1

Conditions: Hypoparathyroidism

Treatments: Drug: Indocyanine Green near infrared fluorescence imaging

Study type: Interventional

Funder types: Other

Identifiers

NCT06579430

201900307

Details and patient eligibility

About

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.

Enrollment: 80 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

Multicenter cohort

Experimental 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).

Treatment:

Drug: Indocyanine Green near infrared fluorescence imaging

Drug: Indocyanine Green near infrared fluorescence imaging

Root cause analysis

Experimental 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.

Treatment:

Drug: Indocyanine Green near infrared fluorescence imaging

Drug: Indocyanine Green near infrared fluorescence imaging