Clinical trial NCT05579782: Assessing Benefits of NIRAF Detection for Identifying Parathyroid Glands During Total Thyroidectomy
Official title: Assessing Benefits of NIRAF Detection for Identifying Parathyroid Glands During Total Thyroidectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Hypoparathyroidism
Thyroid Disease
Thyroid Neoplasms
Thyroid Cancer
Lead sponsor: Medical College of Wisconsin
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: Vanderbilt University
First posted: 2022-10-14
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: NIRAF detection technology is used as an adjunctive tool for intraoperative parathyroid identification in patients who undergo total thyroidectomy (TTx) with or without lymph node dissection (LND) in the interventional group.

Generic Name of Device: Parathyroid Autofluorescence Detection Device (NIRAF detection technology).

The Parathyroid Autofluorescence Detection Device consists of a disposable fiber-optic probe that emits non-ionizing radiation from a NIR 785 nanometer (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 Milliwatts (mW). The device has an FDA clearance for clinical use in general surgeries and dermatological use (Class 2 device).
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Postoperative hypoparathyroidism/hypocalcemia (Immediate)
timeFrame: Within 24 hours of surgery
measure: Postoperative hypoparathyroidism/hypocalcemia (Transient)
timeFrame: 5-14 days after total thyroidectomy
measure: Postoperative hypoparathyroidism/hypocalcemia (Permanent)
timeFrame: 6 months after total thyroidectomy
Secondary outcomes:
measure: Overall number of parathyroid glands identified
timeFrame: Immediate (during total thyroidectomy)
measure: Number of parathyroid glands identified with NIRAF
timeFrame: Immediate (during total thyroidectomy)
measure: Number of frozen sections sent for analysis.
timeFrame: Immediate (during total thyroidectomy)
measure: Number of auto-transplanted parathyroid glands
timeFrame: Immediate (during total thyroidectomy)
measure: Number of nights spent in the hospital after total thyroidectomy
timeFrame: 0-72 hours after total thyroidectomy
measure: Number of inadvertently resected parathyroid glands
timeFrame: Immediate (intraoperative) to 7-10 days after total thyroidectomy (pathology report)
measure: Number of doctor visits/emergency department visits or hospital admissions
timeFrame: Up to 6 months after total thyroidectomy
measure: Duration and total daily dosage of calcium and/or vitamin D supplementation after surgery
timeFrame: Up to 6 months after total thyroidectomy
Other outcomes:
Locations:
city: Milwaukee
country: United States
facility: Froedtert Hospital and Medical College of Wisconsin
state: Wisconsin
Study officials:
References: