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

Not Applicable

Completed

• Conditions: Thyroid Disease; Postoperative Hypoparathyroidism; Thyroid Cancer; Thyroid Neoplasms

• Registration Number: NCT05579782
• Lead Sponsor: Medical College of Wisconsin

Brief Summary

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.

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 Timeline

• Study Start: 2022-10-05
• Study First Submitted: 2022-10-11
• Study First Submitted QC: 2022-10-11
• Study First Posted: 2022-10-14
• Primary Completion: 2024-05-29
• Study Completion: 2024-12-31
• Results First Submitted: 2025-05-23
• Status Verified: 2025-07
• Results First Submitted QC: 2025-07-11
• Last Update Submitted: 2025-07-11
• Results First Posted: 2025-07-31
• Last Update Posted: 2025-07-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Froedtert Hospital and Medical College of Wisconsin; 🇺🇸 Milwaukee, Wisconsin, United States