Assessing Benefits of NIRAF Detection for Identifying Parathyroid Glands During Total Thyroidectomy

This study describes a single center, randomized, single-blinded clinical trial to assess the clinical benefits of the use of near infrared autofluorescence (NIRAF) detection with an FDA-cleared device 'Parathyroid Eye (PTeye)' for identifying parathyroid glands during total thyroidectomy. It compares risk-benefits and outcomes in patients undergoing total thyroidectomy where NIRAF detection with PTeye for parathyroid identification is either used or not used.

Study Overview

• Status: Completed
• Conditions: Thyroid Neoplasms; Thyroid Cancer; Thyroid Disease; Postoperative Hypoparathyroidism
• Intervention / Treatment: Device: NIRAF Detection Technology

Detailed Description

Inadvertent damage or excision of a healthy parathyroid gland (PG) following a total thyroidectomy (TTx) could result in transient hypocalcemia (< 6 months) in 5 - 35% of cases or permanent hypocalcemia (> 6 months) in 7% of the patients (1, 2). In both of these circumstances, patients would require calcium and active vitamin D supplementation in addition to a potentially prolonged hospital stay and/or unplanned hospital readmission adding to unnecessary burden and healthcare costs. These complications could be minimized with label-free intraoperative PG identification using near infrared autofluorescence (NIRAF) detection with a fiber-probe based approach as utilized in 'PTeye', which is medical device that was recently FDA-cleared. However, the true impact of this particular NIRAF-based approach on patient outcomes is yet to be determined

The aim of this prospective single blinded randomized study is to compare 2 groups of patients: TTx patients operated using NIRAF detection technology with PTeye as adjunct tool (NIRAF+) vs. patients operated without the adjunct technology (NIRAF-). The main objective of this study is to assess the benefit of intraoperative use of NIRAF detection technology via PTeye during TTx procedures with regard to postoperative hypocalcemia, PG identification, PG auto-transplantation and inadvertent resection rates compared to standard of care.

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53226
      • Froedtert Hospital and Medical College of Wisconsin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

(i) All patients eligible for total thyroidectomy (TTx), with or without lymph node dissection. (includes patients undergoing a TTx who have undergone a prior neck exploration for parathyroid disease or other but have an intact thyroid).

(ii) All patients undergoing completion thyroidectomy.

Exclusion Criteria:

(i) Patients with concurrent parathyroid disease.

(ii) Patients with incidental enlarged parathyroid discovered during TTx.

(iii) Patients undergoing thyroid lobectomy/partial thyroidectomy.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: NIRAF Detection Technology (+); Parathyroid gland identification will be performed with PTeye using NIRAF detection technology as an adjunctive tool in patients who undergo total thyroidectomy (TTx) with or without lymph node dissection (LND).	Device: NIRAF Detection Technology; Near Infrared Autofluorescence (NIRAF) detection technology or 'PTeye' consists of a disposable fiber-optic probe that emits non-ionizing radiation from a NIR 785 nm laser source, and also transmits the resulting tissue NIRAF to a photo detector. The 785 nm laser source emits a maximum power of 20 mW. The device is FDA cleared for clinical use in general surgeries and dermatological use (Class 2 device). After surgeon identifies a potential parathyroid gland in the surgical field, the surgeon places the fiber-optic probe of PTeye on suspect tissue and presses the device foot-pedal to activate tissue NIRAF measurement. Auditory beep at high frequency with a Detection Ratio > 1.2 is interpreted by device as the suspect tissue being positive for parathyroid. Other Name: PTeye Device
No Intervention: NIRAF Detection Technology (-); Parathyroid gland identification will be performed by the surgeon using only visual identification and without using PTeye - NIRAF detection technology in patients who undergo total thyroidectomy (TTx) with or without lymph node dissection (LND).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subjects With Transient Hypoparathyroidism.	The number of subjects with hypoparathyroidism. For the transient hypoparathyroidism; the definition utilized was a serum parathyroid hormone (PTH) level <10 pg/mL.	24-48 hours post-op
Patients With Hypoparathyroidism at Last Follow-up	The number of subjects with hypoparathyroidism at last follow-up. Follow-up defined as PTH less than the normal institutional range.	2 days to 1 year after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Average Number of Parathyroid Glands Identified With High Confidence.	Overall number of parathyroid glands identified (Experimental Group: Glands identified with naked eye + NIRAF; Control Group: Glands identified with naked eye)	Immediate (during total thyroidectomy, up to 3 hours)
Number of Participants With Frozen Sections Sent for Analysis.	Number of participants with frozen sections sent for analysis during the procedure to confirm potential parathyroid tissue.	Immediate (during total thyroidectomy, up to 3 hours)
Number of Participants With Auto-transplanted Parathyroid Glands	Number of participants with auto-transplanted parathyroid glands if the parathyroid gland was accidentally excised/devascularized.	Immediate (during total thyroidectomy, up to 3 hours)
Number of Participants Who Spent Nights in the Hospital After Total Thyroidectomy	Number of participants who spent nights for postoperative recovery in the hospital after the surgical procedure.	0-72 hours after total thyroidectomy
Number of Participants With Inadvertently Resected Parathyroid Glands	Number of participants with inadvertently resected parathyroid glands when parathyroid tissue is found in the resected thyroid specimens.	Immediate (intraoperative) to 7-10 days after total thyroidectomy (pathology report)
Number of Doctor Visits/Emergency Department Visits or Hospital Admissions	Number of doctor visits/emergency department visits or hospital admissions due to hypocalcemia and or associated symptoms.	Up to 6 months after total thyroidectomy
Duration and Total Daily Dosage of Calcium and/or Vitamin D Supplementation After Surgery	Duration and total daily dosage of calcium and/or vitamin D supplementation after surgery - if patient had no prior history of supplementation.	Up to 6 months after total thyroidectomy

Collaborators and Investigators

• Sponsor: Medical College of Wisconsin
• Collaborators: National Cancer Institute (NCI); Vanderbilt University
• Investigators: Principal Investigator: Tracy S Wang, MD, MPH, Medical College of Wisconsin

Study record dates

Study Major Dates

• Study Start (Actual): October 5, 2022
• Primary Completion (Actual): May 29, 2024
• Study Completion (Actual): December 31, 2024

Study Registration Dates

• First Submitted: October 11, 2022
• First Submitted That Met QC Criteria: October 11, 2022
• First Posted (Actual): October 14, 2022

Study Record Updates

• Last Update Posted (Actual): July 31, 2025
• Last Update Submitted That Met QC Criteria: July 11, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Head and Neck Neoplasms; Parathyroid Diseases; Thyroid Diseases; Hypoparathyroidism; Thyroid Neoplasms
• Other Study ID Numbers: 00040573

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes