Clinical trial NCT06169735: Does Fluorescence With or Without Indocyanine Green Improve Parathyroid Identification and Preservation
Official title: Does Fluorescence With or Without Indocyanine Green Improve Parathyroid Identification and Preservation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Parathyroid Dysfunction
Adenoma
Keywords: Indocyanine Green
Parathyroid Surgery
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: Stryker Nordic
First posted: 2023-12-13
Enrollment: 417
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This is already a pre-approved drug by FDA.
Primary purpose: DIAGNOSTIC

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Percentage of Parathyroid Glands identified by ICG
timeFrame: 20 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: UAB Callahan Eye
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Herbert Chen, MD
role: PRINCIPAL_INVESTIGATOR
References:
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