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

Fujian Medical University

Status: Completed

Conditions: Optical Imaging; Thyroid Cancer; Hypoparathyroidism

Treatments: Diagnostic Test: PTH test strip; Device: Near-infrared devices

Study type: Observational

Funder types: Other

Identifiers

NCT05684029

PT FINDER

Details and patient eligibility

About

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.

Full 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.

Enrollment: 101 patients

Sex: All

Ages: 12 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients diagnosed with thyroid cancer by FNA
• Scheduled for surgical treatment

Exclusion criteria

• Patients with papillary thyroid microcarcinoma who ready for radiofrequency ablation or survival monitoring

Trial design

101 participants in 2 patient groups

Near-infrared Step

Description:

1. Use near-infrared equipment to detect surgical specimens; 2. Timing near-infrared equipment detects parathyroid glands and takes photography; 3. recording the positive tissue in NIRAF; 4. analyzing the accuracy of NIR equipment to see positive points.

Treatment:

Device: Near-infrared devices

Diagnostic Test: PTH test strip

Senior Surgeon Step

Description:

1. Senior Surgeon inspects for parathyroid glands in postoperative thyroid specimens with the naked eye; 2. Timing senior doctors with parathyroid glands; 3. PTH test strips confirm all suspicious tissues. 4. all analyzing the accuracy of the positive points of senior doctors.

Treatment:

Diagnostic Test: PTH test strip