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

The University of Alabama at Birmingham

Status and phase: Enrolling; Phase 4

Conditions: Parathyroid Dysfunction; Adenoma

Treatments: Drug: Indocyanine green; Device: SPY Portable Handheld Imaging

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT06169735

Stryker (Other Identifier)

IRB-300011872

Details and patient eligibility

About

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

Full description

The accurate identification of the parathyroid gland is a crucial aspect of thyroid and parathyroid surgery. Failing to recognize the parathyroid gland during thyroidectomy can result in the inadvertent removal of the gland, leading to postoperative hypocalcemia. On the other hand, during parathyroidectomy, there is a risk of mistaking other structures, such as lymph nodes, for parathyroid adenomas, which can leave the patient without a cure. Currently UAB employs intraoperative PTH or radioactive isotope techniques in conjunction with surgeon judgment. However, both methods have limitations, including being time-consuming, posing logistical challenges, and not providing feedback before gland removal.

Parathyroid fluorescence is a relatively new technology. It was initially discovered that the parathyroid gland emits fluorescence, which distinguishes it from the surrounding tissues. Additionally, indocyanine green dye is readily taken up by the parathyroid gland, making its detection easy to the naked eye. Research has demonstrated that parathyroid fluorescence, with or without indocyanine green, is not only safe but also helps reduce postoperative hypocalcemia and locate lesions in patients with imaging-negative parathyroid adenomas. However, the current use of parathyroid fluorescence is not standardized, and further studies are needed to explore its clinical utility in terms of cure rates and postoperative complications.

Enrollment: 417 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• age greater than 18 years old

Exclusion criteria

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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417 participants in 1 patient group

Parathyroid patients

Experimental group

Description:

patients who require parathyroid identification and preservation during parathyroid surgery maneuver

Treatment:

Device: SPY Portable Handheld Imaging

Drug: Indocyanine green