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

NCT05684029 | Completed

• 1 other identifier: PT FINDER
• Study Type: observational
• Target: 101
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Thyroid Cancer; Hypoparathyroidism; Optical Imaging

Keywords

PTH test strip; near-infrared autofluorescence (NIRAF); Thyroid Cancer

Outcome Measures

Primary Outcomes (3)

• 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.

• 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.

• 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 Outcomes (2)

• inspect duration

  During operation, From initial examination to finding suspicious parathyroid tissue, excluding subsequent PTH testing steps

• 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.

Study Arms (2)

Near-infrared Step

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.

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

Senior Surgeon Step

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.

Diagnostic Test: PTH test strip

Interventions

Near-infrared devices DEVICE

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.

Near-infrared Step

PTH test strip DIAGNOSTIC_TEST

The PTH test strip is to detect the PTH in the specimen by immunocolloidal gold technology to determine whether it is parathyroid.

Near-infrared Step; Senior Surgeon Step

Eligibility Criteria

• Age: 12 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients diagnosed with thyroid cancer by FNA and scheduled for surgical treatment.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Fujian Medical University: lead

Study Sites (1)

Fujian Medical University Union Hospital

Fuzhou, Fujian, 350001, China

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Thyroid surgical specimens, including the thyroid gland, central compartment lymph nodes, and adipose tissue, may include ischemic parathyroid glands. These parathyroid glands, if exist, will transplant back into the patient's body after they are identified.

MeSH Terms

Conditions

Thyroid Neoplasms; Hypoparathyroidism

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Endocrine System Diseases; Thyroid Diseases; Parathyroid Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Head of Thyroid Surgery, Principal Investigator, Clinical Professor

Study Record Dates

• First Submitted: November 27, 2022
• First Posted: January 13, 2023
• Study Start: November 1, 2022
• Primary Completion: March 31, 2023
• Study Completion: October 31, 2023
• Last Updated: April 19, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)