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

Thyroid Cancer Clinical Trial

— NIRAF  

Official title:

Assessing Benefits of Near Infrared Autofluorescence (NIRAF) Detection for Identifying Parathyroid Glands During Total Thyroidectomy.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04281875
• Other study ID #: VICC HN 2017
• Secondary ID: 5R01CA212147-02
• Status: Completed
• Phase: N/A
• Start date: March 16, 2020
• Est. completion date: February 23, 2024

Study information

• Verified date: February 2024
• Source: Vanderbilt-Ingram Cancer Center
• 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 (PGs) during total thyroidectomy (TTx). It compares risk-benefits and outcomes in TTx patients 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 (3 - 5) as utilized in 'PTeye', which is medical device that was recently FDA-cleared (6). 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: Completed
• Enrollment: 160
• Est. completion date: February 23, 2024
• Est. primary completion date: February 23, 2024
• Accepts healthy volunteers: No
• 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 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.

Locations

Country	Name	City	State
United States	Vanderbilt University Medical Center	Nashville	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
Vanderbilt-Ingram Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (6)

Antakia R, Edafe O, Uttley L, Balasubramanian SP. Effectiveness of preventative and other surgical measures on hypocalcemia following bilateral thyroid surgery: a systematic review and meta-analysis. Thyroid. 2015 Jan;25(1):95-106. doi: 10.1089/thy.2014.0101. — View Citation

Edafe O, Antakia R, Laskar N, Uttley L, Balasubramanian SP. Systematic review and meta-analysis of predictors of post-thyroidectomy hypocalcaemia. Br J Surg. 2014 Mar;101(4):307-20. doi: 10.1002/bjs.9384. Epub 2014 Jan 9. — View Citation

McWade MA, Sanders ME, Broome JT, Solorzano CC, Mahadevan-Jansen A. Establishing the clinical utility of autofluorescence spectroscopy for parathyroid detection. Surgery. 2016 Jan;159(1):193-202. doi: 10.1016/j.surg.2015.06.047. Epub 2015 Oct 9. — View Citation

Thomas G, McWade MA, Nguyen JQ, Sanders ME, Broome JT, Baregamian N, Solorzano CC, Mahadevan-Jansen A. Innovative surgical guidance for label-free real-time parathyroid identification. Surgery. 2019 Jan;165(1):114-123. doi: 10.1016/j.surg.2018.04.079. Epub 2018 Nov 12. — View Citation

Thomas G, McWade MA, Paras C, Mannoh EA, Sanders ME, White LM, Broome JT, Phay JE, Baregamian N, Solorzano CC, Mahadevan-Jansen A. Developing a Clinical Prototype to Guide Surgeons for Intraoperative Label-Free Identification of Parathyroid Glands in Real Time. Thyroid. 2018 Nov;28(11):1517-1531. doi: 10.1089/thy.2017.0716. Epub 2018 Sep 11. — View Citation

Voelker R. Devices Help Surgeons See Parathyroid Tissue. JAMA. 2018 Dec 4;320(21):2193. doi: 10.1001/jama.2018.18768. No abstract available. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative hypoparathyroidism/hypocalcemia (Immediate)	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 after total thyroidectomy.
Primary	Postoperative hypoparathyroidism/hypocalcemia (Transient)	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)	If blood calcium has not normalized at 1st postsurgical clinical visit, total calcium level is subsequently measured as necessary. Patient is defined to have permanent hypoparathyroidism if hypocalcemia 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 procedure.
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 procedure.
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 procedure.
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 procedure.
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 (as presented in the pathology report)
Secondary	Number of doctor visits/emergency department visits or hospital admissions	7.8. 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	8.9. 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