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RECRUITING
NCT06169735
PHASE4

Does Fluorescence With or Without Indocyanine Green Improve Parathyroid Identification and Preservation

Sponsor: University of Alabama at Birmingham

View on ClinicalTrials.gov

Summary

The aim of this study is to determine if fluorescence with or without indocyanine green can facilitate safe and accurate thyroid and parathyroid surgery.

Key Details

Gender

All

Age Range

19 Years - Any

Study Type

INTERVENTIONAL

Enrollment

417

Start Date

2024-04-11

Completion Date

2026-05-01

Last Updated

2025-05-06

Healthy Volunteers

No

Interventions

DRUG

Indocyanine green

ICG Administration: All enrolled patients with scheduled thyroidectomy or parathyroidectomy will receive a standard cervical incision that afford access to either side of neck. Following sufficient exposure of thyroid, 25 mg of indocyanine green (ICG), reconstituted in 10 ml of sterile water, will be administered intravenously. A dosage of 1 ml of this solution will be injected into a peripheral IV line, followed by a 5 ml flush of normal saline to ensure the propagation of the dye within the vascular compartment.

DEVICE

SPY Portable Handheld Imaging

Fluorescent Imaging: Approximately 30 seconds post-administration, the parathyroid glands are expected to exhibit fluorescence under near-infrared imaging. The emitted fluorescence is anticipated to persist for approximately 20 minutes, allowing ample time for intraoperative evaluation of parathyroid viability and perfusion

Locations (1)

UAB Callahan Eye

Birmingham, Alabama, United States