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

Thyroid Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05579782
• Other study ID #: 00040573
• Status: Active, not recruiting
• Phase: N/A
• Start date: October 5, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: February 2024
• Source: Medical College of Wisconsin
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 80
• Est. completion date: December 31, 2024
• Est. primary completion date: July 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hypoparathyroidism
• Postoperative Hypoparathyroidism
• Thyroid Cancer
• Thyroid Disease
• Thyroid Diseases
• Thyroid Neoplasms

Intervention

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

Locations

Country	Name	City	State
United States	Froedtert Hospital and Medical College of Wisconsin	Milwaukee	Wisconsin

Sponsors (3)

Lead Sponsor	Collaborator
Medical College of Wisconsin	National Cancer Institute (NCI), Vanderbilt University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative hypoparathyroidism/hypocalcemia (Immediate)	The number of subjects with postoperative low calcium (total calcium <8mg/dL or <2mmol/L) and/or undetectable parathyroid hormone (PTH) (serum intact PTH < 16 pg/mL or 1 pmol/L) within 24 hours after surgery	Within 24 hours of surgery
Primary	Postoperative hypoparathyroidism/hypocalcemia (Transient)	The number of subjects with undetectable postoperative PTH and/or low calcium (total calcium < 2mmol/L or 8 mg/dL, serum intact PTH < 16 pg/mL or 1 pmol/L) at first postoperative visit (usually 5-14 days after total thyroidectomy).	5-14 days after total thyroidectomy
Primary	Postoperative hypoparathyroidism/hypocalcemia (Permanent)	The number of subjects with permanent hypoparathyroidism, which is hypocalcemia that persists and/or activated Vitamin D is required to be symptom free at or after the 6th postoperative month.	6 months after total thyroidectomy
Secondary	Overall number of parathyroid glands identified	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)
Secondary	Number of parathyroid glands identified with NIRAF	Number of parathyroid glands identified with NIRAF, which was not seen with surgeon's naked eye.	Immediate (during total thyroidectomy)
Secondary	Number of frozen sections sent for analysis.	Number of frozen sections sent for analysis during the procedure to confirm potential parathyroid tissue	Immediate (during total thyroidectomy)
Secondary	Number of auto-transplanted parathyroid glands	Number of auto-transplanted parathyroid glands if the parathyroid gland was accidentally excised/devascularized.	Immediate (during total thyroidectomy)
Secondary	Number of nights spent in the hospital after total thyroidectomy	Number of nights spent for postoperative recovery in the hospital after the surgical procedure.	0-72 hours after total thyroidectomy
Secondary	Number of inadvertently resected parathyroid glands	Number of 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)
Secondary	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
Secondary	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