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

• Sponsor: Vanderbilt-Ingram Cancer Center (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04281875
• Collaborator: National Cancer Institute (NCI) (NIH)
• Enrollment: 160
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 41.5
• Patients Per Site Per Month: 3.9

Study Details

Study Description

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 (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.

Condition or Disease	Intervention/Treatment	Phase
Postoperative Hypoparathyroidism; Thyroid Neoplasms; Thyroid Cancer	Device: NIRAF Detection Technology	N/A

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 (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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 160 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• 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).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).
• Masking: Single (Participant)
• Masking Description: Only participants will be masked to the intervention.
• Primary Purpose: Prevention
• Official Title: Assessing Benefits of Near Infrared Autofluorescence (NIRAF) Detection for Identifying Parathyroid Glands During Total Thyroidectomy.
• Actual Study Start Date: Mar 16, 2020
• Anticipated Primary Completion Date: Mar 1, 2023
• Anticipated Study Completion Date: Sep 1, 2023

Arms and Interventions

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 Names: PTeye Device
No Intervention: NIRAF Detection Technology - Parathyroid gland identification will be performed with the naked eye of the surgeon without using PTeye - NIRAF detection technology in patients who undergo total thyroidectomy (TTx) with or without lymph node dissection (LND).

Outcome Measures

Primary Outcome Measures

1. Postoperative hypoparathyroidism/hypocalcemia (Immediate) [Within 24 hours after total thyroidectomy.]

   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

2. Postoperative hypoparathyroidism/hypocalcemia (Transient) [5-14 days after total thyroidectomy.]

   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).

3. Postoperative hypoparathyroidism/hypocalcemia (Permanent) [6 months after total thyroidectomy]

   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.

Secondary Outcome Measures

1. Overall number of parathyroid glands identified. [Immediate. During total thyroidectomy procedure.]

   Overall number of parathyroid glands identified (Experimental Group: Glands identified with naked eye + NIRAF; Control Group: Glands identified with naked eye)

2. Number of parathyroid glands identified with NIRAF [Immediate. During total thyroidectomy procedure.]

   Number of parathyroid glands identified with NIRAF, which was not seen with surgeon's naked eye.

3. Number of frozen sections sent for analysis. [Immediate. During total thyroidectomy procedure.]

   Number of frozen sections sent for analysis during the procedure to confirm potential parathyroid tissue

4. Number of auto-transplanted parathyroid glands [Immediate. During total thyroidectomy procedure.]

   Number of auto-transplanted parathyroid glands if the parathyroid gland was accidentally excised/devascularized.

5. Number of nights spent in the hospital after total thyroidectomy [0 - 72 hours after total thyroidectomy]

   Number of nights spent for postoperative recovery in the hospital after the surgical procedure.

6. Number of inadvertently resected parathyroid glands [Immediate (intraoperative) to 7-10 days after total thyroidectomy (as presented in the pathology report)]

   Number of inadvertently resected parathyroid glands when parathyroid tissue is found in the resected thyroid specimens.

7. Number of doctor visits/emergency department visits or hospital admissions [Up to 6 months after total thyroidectomy]

   7.8. Number of doctor visits/emergency department visits or hospital admissions due to hypocalcemia and or associated symptoms.

8. Duration and total daily dosage of calcium and/or vitamin D supplementation after surgery [Up to 6 months after total thyroidectomy]

   8.9. Duration and total daily dosage of calcium and/or vitamin D supplementation after surgery - if patient had no prior history of supplementation.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 99 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Vanderbilt University Medical Center	Nashville	Tennessee	United States	37212

Sponsors and Collaborators

• Vanderbilt-Ingram Cancer Center
• National Cancer Institute (NCI)

Investigators

• Principal Investigator: Carmen C Solorzano, MD, FACS, Vanderbilt University Medical Center

Study Documents (Full-Text)

• Informed Consent Form - Dec 30, 2020

More Information

Publications

• 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. Review.
• 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. Review.
• McWade MA, Sanders ME, Broome JT, Solórzano 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.
• Thomas G, McWade MA, Nguyen JQ, Sanders ME, Broome JT, Baregamian N, Solórzano 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.
• Thomas G, McWade MA, Paras C, Mannoh EA, Sanders ME, White LM, Broome JT, Phay JE, Baregamian N, Solórzano 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.
• Voelker R. Devices Help Surgeons See Parathyroid Tissue. JAMA. 2018 Dec 4;320(21):2193. doi: 10.1001/jama.2018.18768.

• Responsible Party: Carmen Solorzano, Professor of Surgery Chair, Department of Surgery Director, Vanderbilt Endocrine Surgery, Vanderbilt-Ingram Cancer Center
• ClinicalTrials.gov Identifier: NCT04281875
• Other Study ID Numbers: VICC HN 2017; 5R01CA212147-02
• First Posted: Feb 24, 2020
• Last Update Posted: Apr 12, 2022
• Last Verified: Apr 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• 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
• Keywords provided by Carmen Solorzano, Professor of Surgery Chair, Department of Surgery Director, Vanderbilt Endocrine Surgery, Vanderbilt-Ingram Cancer Center: Total Thyroidectomy; Intraoperative Parathyroid Identification; Near Infrared Autofluorescence; Postoperative Hypocalcemia; Postoperative Hypoparathyroidism
• Additional relevant MeSH terms: Thyroid Neoplasms; Thyroid Diseases; Hypoparathyroidism

Study Results

No Results Posted as of Apr 12, 2022