Diagnostic Accuracy Study of Indocyanine Green for Parathyroid Perfusion

Status Completed

Clinical Trial Summary

This study aims to develop a standardized universal imaging protocol for ICG-guided fluorescent total thyroidectomy, including quantitative evaluations of the fluorescent signal. Therefore, patients will undergo thyroid surgery (total thyroidectomy) with the use of ICG fluorescence.

Clinical Trial Description

Background Thyroid surgery volume continues to increase worldwide over the past few decades. During a total thyroidectomy (TTx), the ultimate goal is to remove all thyroid tissue, whereas damage to adjacent tissue is prevented. However, iatrogenic hypoparathyroidism, as a result of surgical removal or damage to the parathyroid glands, occurs in approximately 30% of the cases. In 2016 near-infrared fluorescence guided surgery with indocyanine green (ICG) was proposed for visualizing viability and blood supply of parathyroid glands during TTx. ICG can visualize tissue perfusion, since it becomes completely and permanently fixed to plasma proteins once in the bloodstream, and circulates in the intravascular compartment only. However, one of the limitations of ICG imaging is the subjectivity of the interpretation of fluorescence, which makes the assessment of images inconsistent among studies. There is a clear need for standardization of the evaluation of the perfusion with ICG, since visual evaluation of the fluorescent signal of ICG is not sufficient to reliably predict the perfusion of parathyroid glands.

Main research question To develop a standardized universal imaging protocol for ICG-guided fluorescent total thyroidectomy including quantitative evaluations of the fluorescent signal.

Design This will be a proof-of-concept , prospective cohort study of patients undergoing a total thyroidectomy with ICG-guided fluorescent surgery to evaluate tissue perfusion The main study endpoint is quantification of the fluorescent signal of ICG. Secondary outcomes are data from surgery, postoperative lab values (including calcium, PTH, albumin) and postoperative medication use. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03969108
Study type	Interventional
Source	University Health Network, Toronto
Contact
Status	Completed
Phase	Phase 4
Start date	August 6, 2019
Completion date	November 13, 2019

View Details

See also
Status	Clinical Trial	Phase
Recruiting	`NCT05774535` - Prospective, Observational Study on the Carotid Intima-media Thickness in Patients Undergoing Thyroid Surgery
Withdrawn	`NCT04224792` - Effects of Exercise Training on Fatigue in Thyroid Cancer Survivors	N/A
Completed	`NCT01728623` - A Study of E7080 in Subjects With Advanced Thyroid Cancer	Phase 2
Recruiting	`NCT03175224` - APL-101 Study of Subjects With NSCLC With c-Met EXON 14 Skip Mutations and c-Met Dysregulation Advanced Solid Tumors	Phase 2
Completed	`NCT02911155` - Cancer and Other Disease Risks in U.S. Nuclear Medicine Technologists
Recruiting	`NCT05025046` - NGS-based Thyroscan Genomic Classifier in the Diagnosis of Thyroid Nodules
Not yet recruiting	`NCT03978351` - The Role of Midkine in Diagnosis of Thyroid Cancer
Completed	`NCT02658513` - Evaluation of Lancet Blood Sampling for Radioiodine Dosimetry in Thyroid Cancer
Terminated	`NCT02628535` - Safety Study of MGD009 in B7-H3-expressing Tumors	Phase 1
Withdrawn	`NCT01994200` - Developing and Implementing an Interdisciplinary Team-Based Care Approach (ITCA-ThyCa) for Thyroid Cancer Patients	Phase 1/Phase 2
Completed	`NCT02375451` - Effect of Childhood Radioiodine Therapy on Salivary Function	N/A
Terminated	`NCT01403324` - Comparison of Dosimetry After rhTSH or Withdrawal of Thyroid Hormone in Metastatic or Locally Advanced Thyroid Cancer	N/A
Completed	`NCT00970359` - Reacquisition of Radioactive Iodine (RAI) Uptake of RAI-Refractory Metastatic Thyroid Cancers by Pretreatment With the Selective MEK Inhibitor AZD6244	N/A
Completed	`NCT00439478` - Dental Safety Profile of High-Dose Radioiodine Therapy	Phase 4
Completed	`NCT00223158` - Evaluation Study of L-T3 Utility in the Follow-up of Patients With Thyroid Cancer	N/A
Active, not recruiting	`NCT03246958` - Nivolumab Plus Ipilimumab in Thyroid Cancer	Phase 2
Active, not recruiting	`NCT04544111` - PDR001 Combination Therapy for Radioiodine-Refractory Thyroid Cancer	Phase 2
Completed	`NCT04876287` - Salivary dysfuncTion After Radioiodine Treatment
Recruiting	`NCT06073223` - Intervention to Decrease Overtreatment of Patients With Low-risk Thyroid Cancer	N/A
Recruiting	`NCT06037174` - Comparison of Quality of Life in Patients With Differentiated Thyroid Carcinoma Undergoing Different Surgery

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Diagnostic Accuracy Study of Indocyanine Green for Parathyroid Perfusion Assessment

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms