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

Primary Purpose

Postoperative Hypoparathyroidism, Thyroid Neoplasms, Thyroid Cancer

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
NIRAF Detection Technology
Sponsored by
Vanderbilt-Ingram Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Postoperative Hypoparathyroidism focused on measuring Total Thyroidectomy, Intraoperative Parathyroid Identification, Near Infrared Autofluorescence, Postoperative Hypocalcemia, Postoperative Hypoparathyroidism

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept 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

  • Vanderbilt University Medical CenterRecruiting

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 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).

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
7.8. 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
8.9. 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
February 19, 2020
Last Updated
February 7, 2023
Sponsor
Vanderbilt-Ingram Cancer Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT04281875
Brief Title
Assessing Benefits of NIRAF Detection for Identifying Parathyroid Glands During Total Thyroidectomy.
Acronym
NIRAF
Official Title
Assessing Benefits of Near Infrared Autofluorescence (NIRAF) Detection for Identifying Parathyroid Glands During Total Thyroidectomy.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 16, 2020 (Actual)
Primary Completion Date
October 30, 2023 (Anticipated)
Study Completion Date
November 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vanderbilt-Ingram Cancer Center
Collaborators
National Cancer Institute (NCI)

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
No

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 (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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Hypoparathyroidism, Thyroid Neoplasms, Thyroid Cancer
Keywords
Total Thyroidectomy, Intraoperative Parathyroid Identification, Near Infrared Autofluorescence, Postoperative Hypocalcemia, Postoperative Hypoparathyroidism

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
160 (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 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).
Intervention Type
Device
Intervention Name(s)
NIRAF Detection Technology
Other Intervention Name(s)
PTeye Device
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.
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 after total thyroidectomy.
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 procedure.
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 procedure.
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 procedure.
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 procedure.
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 (as presented in the pathology report)
Title
Number of doctor visits/emergency department visits or hospital admissions
Description
7.8. 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
8.9. 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
No
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
Vanderbilt-Ingram Service L for Timely Access
Phone
800-811-8480
Email
cip@vumc.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carmen C Solorzano, MD, FACS
Organizational Affiliation
Vanderbilt University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37212
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carmen C Solorzano, MD,FACS
First Name & Middle Initial & Last Name & Degree
Colleen M Kiernan, MD,MPH
First Name & Middle Initial & Last Name & Degree
Naira Baregamian, MD,FACS
First Name & Middle Initial & Last Name & Degree
Sarah L Rohde, MD

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Informed Consent Form and Clinical Study Report will be made available to other researchers as per the specified time-frame.
IPD Sharing Time Frame
Clinical Study Report will be shared 6 months after publication of trial data and will be available till end date of trial. Informed Consent Form will be shared for a year after the primary completion date of the trial.
IPD Sharing Access Criteria
Request for Individual Patient Data (IPD) - Informed consent Form and Clinical Study Report - will be reviewed by the principal investigator of this clinical trial, before granting access to IPD
Citations:
PubMed Identifier
25203484
Citation
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.
Results Reference
background
PubMed Identifier
24402815
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.
Results Reference
background
PubMed Identifier
26454675
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.
Results Reference
background
PubMed Identifier
30084742
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.
Results Reference
background
PubMed Identifier
30442424
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.
Results Reference
background
PubMed Identifier
30512085
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.
Results Reference
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Assessing Benefits of NIRAF Detection for Identifying Parathyroid Glands During Total Thyroidectomy.

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