Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06579430
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-08-21
Brief Title:
Diagnostic Accuracy Study of Indocyanine Green for Perfusion Assessment
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Diagnostic Accuracy Study of Indocyanine Green for Perfusion Assessment
Status:
COMPLETED
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Pre-CLOVER
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 confoundersoutcomes 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 gt70 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
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 confoundersoutcomes 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 gt70 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None