RecruitingPhase 4NCT06169735

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


Sponsor

University of Alabama at Birmingham

Enrollment

417 participants

Start Date

Apr 11, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 19 Years

Inclusion Criteria1

  • age greater than 18 years old

Exclusion Criteria3

  • Patients with iodine or shellfish allergies would be excluded.
  • Patients with allergy to indocyanine green.
  • Pregnancy

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGIndocyanine 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.

DEVICESPY 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

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06169735


Related Trials