NCT05684029

Near-Infrared Autofluorescence With PTH Test Strip as an SOP of Parathyroid in Thyroid Surgery

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 101 (actual)
• Sponsor: Fujian Medical University · Academic / Other
• Sex: All
• Age: 12 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective study aiming to establish near-infrared autofluorescence technology and PTH test strip as a standardized process for finding and identifying parathyroid glands in thyroid surgery.

Detailed description

This is a prospective study aiming to establish near-infrared autofluorescence technology and PTH test strip as a standardized process for finding and identifying parathyroid glands in thyroid surgery. NIFRA first photographed all specimens from thyroidectomy with or without central neck dissection, and positive tissues under near-infrared light were recorded in a neck map. Then, a senior surgeon examined the parathyroid glands with the naked eye. These suspicious tissues were then identified with the PTH test strip as a gold standard. Finally, the parathyroid glands discovered during the operation that could not be preserved in situ were excluded from the procedure comparison and classified as strategic parathyroid transplantation.

Conditions

• Thyroid Cancer
• Hypoparathyroidism
• Optical Imaging

Interventions

Type	Name	Description
DEVICE	Near-infrared devices	This device can emit and collect near-infrared light of a specific wavelength. The parathyroid glands in the specimen appear as a high-brightness image in the device, to find the parathyroid gland that may be accidentally removed from the specimen.
DIAGNOSTIC_TEST	PTH test strip	The PTH test strip is to detect the PTH in the specimen by immunocolloidal gold technology to determine whether it is parathyroid.

Timeline

• Start date: 2022-11-01
• Primary completion: 2023-03-31
• Completion: 2023-10-31
• First posted: 2023-01-13
• Last updated: 2024-04-19

Locations

1 site across 1 country: China