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

PHASE4RecruitingINTERVENTIONAL
Enrollment

417

Participants

Timeline

Start Date

April 11, 2024

Primary Completion Date

May 1, 2026

Study Completion Date

May 1, 2026

Conditions
Parathyroid DysfunctionAdenoma
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

Trial Locations (1)

35233

RECRUITING

UAB Callahan Eye, Birmingham

All Listed Sponsors
collaborator

Stryker Nordic

INDUSTRY

lead

University of Alabama at Birmingham

OTHER