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

Primary Purpose

Postoperative Hypoparathyroidism, Thyroid Disease, Thyroid Neoplasms

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
NIRAF Detection Technology
Sponsored by
Medical College of Wisconsin
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Postoperative Hypoparathyroidism

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Froedtert Hospital and Medical College of WisconsinRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

NIRAF Detection Technology (+)

NIRAF Detection Technology (-)

Arm Description

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).

Parathyroid gland identification will be performed by the surgeon using only visual identification and without using PTeye - NIRAF detection technology in patients who undergo total thyroidectomy (TTx) with or without lymph node dissection (LND).

Outcomes

Primary Outcome Measures

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
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).
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.

Secondary Outcome Measures

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)
Number of parathyroid glands identified with NIRAF
Number of parathyroid glands identified with NIRAF, which was not seen with surgeon's naked eye.
Number of frozen sections sent for analysis.
Number of frozen sections sent for analysis during the procedure to confirm potential parathyroid tissue
Number of auto-transplanted parathyroid glands
Number of auto-transplanted parathyroid glands if the parathyroid gland was accidentally excised/devascularized.
Number of nights spent in the hospital after total thyroidectomy
Number of nights spent for postoperative recovery in the hospital after the surgical procedure.
Number of inadvertently resected parathyroid glands
Number of inadvertently resected parathyroid glands when parathyroid tissue is found in the resected thyroid specimens.
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.
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.

Full Information

First Posted
October 11, 2022
Last Updated
October 11, 2022
Sponsor
Medical College of Wisconsin
Collaborators
National Cancer Institute (NCI), Vanderbilt University
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1. Study Identification

Unique Protocol Identification Number
NCT05579782
Brief Title
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

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 5, 2022 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Medical College of Wisconsin
Collaborators
National Cancer Institute (NCI), Vanderbilt University

4. Oversight

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
Data Monitoring Committee
Yes

5. 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Hypoparathyroidism, Thyroid Disease, Thyroid Neoplasms, Thyroid Cancer

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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).
Masking
Participant
Masking Description
Only participants will be masked to the intervention.
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
NIRAF Detection Technology (+)
Arm Type
Experimental
Arm Description
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).
Arm Title
NIRAF Detection Technology (-)
Arm Type
No Intervention
Arm Description
Parathyroid gland identification will be performed by the surgeon using only visual identification and without using PTeye - NIRAF detection technology in patients who undergo total thyroidectomy (TTx) with or without lymph node dissection (LND).
Intervention Type
Device
Intervention Name(s)
NIRAF Detection Technology
Intervention Description
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
Primary Outcome Measure Information:
Title
Postoperative hypoparathyroidism/hypocalcemia (Immediate)
Description
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
Time Frame
Within 24 hours of surgery
Title
Postoperative hypoparathyroidism/hypocalcemia (Transient)
Description
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).
Time Frame
5-14 days after total thyroidectomy
Title
Postoperative hypoparathyroidism/hypocalcemia (Permanent)
Description
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.
Time Frame
6 months after total thyroidectomy
Secondary Outcome Measure Information:
Title
Overall number of parathyroid glands identified
Description
Overall number of parathyroid glands identified (Experimental Group: Glands identified with naked eye + NIRAF; Control Group: Glands identified with naked eye)
Time Frame
Immediate (during total thyroidectomy)
Title
Number of parathyroid glands identified with NIRAF
Description
Number of parathyroid glands identified with NIRAF, which was not seen with surgeon's naked eye.
Time Frame
Immediate (during total thyroidectomy)
Title
Number of frozen sections sent for analysis.
Description
Number of frozen sections sent for analysis during the procedure to confirm potential parathyroid tissue
Time Frame
Immediate (during total thyroidectomy)
Title
Number of auto-transplanted parathyroid glands
Description
Number of auto-transplanted parathyroid glands if the parathyroid gland was accidentally excised/devascularized.
Time Frame
Immediate (during total thyroidectomy)
Title
Number of nights spent in the hospital after total thyroidectomy
Description
Number of nights spent for postoperative recovery in the hospital after the surgical procedure.
Time Frame
0-72 hours after total thyroidectomy
Title
Number of inadvertently resected parathyroid glands
Description
Number of inadvertently resected parathyroid glands when parathyroid tissue is found in the resected thyroid specimens.
Time Frame
Immediate (intraoperative) to 7-10 days after total thyroidectomy (pathology report)
Title
Number of doctor visits/emergency department visits or hospital admissions
Description
Number of doctor visits/emergency department visits or hospital admissions due to hypocalcemia and or associated symptoms.
Time Frame
Up to 6 months after total thyroidectomy
Title
Duration and total daily dosage of calcium and/or vitamin D supplementation after surgery
Description
Duration and total daily dosage of calcium and/or vitamin D supplementation after surgery - if patient had no prior history of supplementation.
Time Frame
Up to 6 months after total thyroidectomy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tracy S Wang, MD, MPH
Phone
414-955-1459
Email
tswang@mcw.edu
Facility Information:
Facility Name
Froedtert Hospital and Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tracy S Wang, MD, MPH
Phone
414-955-1459
Email
tswang@mcw.edu

12. IPD Sharing Statement

Plan to Share IPD
No

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

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