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

Thyroid Cancer Clinical Trial

— PTFINDER  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05684029
• Other study ID #: PT FINDER
• Status: Completed
• Start date: November 1, 2022
• Est. completion date: October 31, 2023

Study information

• Verified date: April 2024
• Source: Fujian Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 101
• Est. completion date: October 31, 2023
• Est. primary completion date: March 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypoparathyroidism
• Optical Imaging
• Thyroid Cancer
• Thyroid Diseases
• Thyroid Neoplasms

Intervention

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.

Locations

Country	Name	City	State
China	Fujian Medical University Union Hospital	FuZhou	Fujian

Sponsors (1)

Lead Sponsor	Collaborator
Fujian Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Positive tissue identify by NIFRA	Surgical specimens were photographed with NIRAF, and the location and amount of positive tissue were recorded and marked on the neck map.	During operation, Surgical specimens were photographed with NIRAF, and the location and amount of positive tissue were recorded and marked on the neck map.
Primary	Suspicious parathyroid tissue found by surgeons	Surgeons looked for suspicious parathyroid tissue with the naked eye and divided them into less than 10% confidence group, 10-90% confidence group, and greater than 90% confidence group. These tissues are tested with PTH strips to confirm that they are parathyroid tissue.	During operation, Surgeons looked for suspicious parathyroid tissue with the naked eye and These tissues are tested with PTH strips to confirm that they are parathyroid.
Primary	number of strategic parathyroid transplantation	The parathyroid glands that had been discovered during the operation that could not be preserved in situ were excluded from the procedure comparison and classified as strategic parathyroid transplantation.	During operation, The parathyroid glands that had been discovered during the operation that could not be preserved in situ were excluded from the procedure comparison and classified as strategic parathyroid transplantation.
Secondary	inspect duration	inspect duration in difference method	During operation, From initial examination to finding suspicious parathyroid tissue, excluding subsequent PTH testing steps
Secondary	The number of parathyroid glands in pathological report	The number of parathyroid glands in pathological report	Up to 4 weeks, The number of parathyroid glands in pathological report excludes fragments of parathyroid glands less than 3mm in diameter.