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

Primary Purpose

Thyroid Neoplasms, Thyroid Diseases, Hypoparathyroidism

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
PTeye
Sponsored by
University of Michigan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients with thyroid disease who will be undergoing total thyroidectomy (includes patients who have undergone a prior neck exploration for parathyroid disease or other but have an intact thyroid gland).
  • Patients with persisting thyroid disease and will be undergoing re-operative or completion thyroidectomy.

Exclusion Criteria:

  • Pregnant women
  • Patients with concurrent parathyroid and thyroid disease
  • Patients with incidental enlarged parathyroid discovered during thyroidectomy procedure.
  • Patients undergoing thyroid lobectomy or partial thyroidectomy

Sites / Locations

  • The University of MichiganRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

PTeye

Standard of Care

Arm Description

The surgeon will use the PTeye as an intraoperative tool to identify if a suspect tissue is a parathyroid or not, during the total thyroidectomy procedure.

The surgeon will not use the PTeye and will proceed with the total thyroidectomy as usual, while relying solely on her/his surgical experience in identifying the parathyroid glands during the operations.

Outcomes

Primary Outcome Measures

Blood calcium levels
Blood calcium levels
Blood parathyroid hormone (PTH) levels
Blood parathyroid hormone (PTH) levels
Blood parathyroid hormone (PTH) levels

Secondary Outcome Measures

Duration in minutes of surgery
Number of frozen section analysis performed(By case)
Percent of frozen sections confirmed as parathyroid tissue
Permanent histology reports of all excised tissues
History of calcium and/or Vitamin D supplementation
History of calcium and/or Vitamin D supplementation
Duration of calcium and/or Vitamin D supplementation
Duration measured in days
Duration of calcium and/or Vitamin D supplementation
Duration measured in days
Number of postsurgical complications
Medical record review
Frequency of Emergency Room (ER) visits or hospitalization due to low blood calcium within 30 days of surgery
Medical record review
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.
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)

Full Information

First Posted
August 22, 2021
Last Updated
September 27, 2023
Sponsor
University of Michigan
Collaborators
National Cancer Institute (NCI), Vanderbilt University
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1. Study Identification

Unique Protocol Identification Number
NCT05022667
Brief Title
Assessing Benefits of Near Infrared Autofluorescence (NIRAF) Detection for Identifying Parathyroid Glands During Total Thyroidectomy
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
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 1, 2021 (Actual)
Primary Completion Date
August 2024 (Anticipated)
Study Completion Date
August 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan
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

5. Study Description

Brief Summary
This study will see if the use of near infrared autofluorescence (NIRAF) detection with a 'Parathyroid Eye (PTeye)' for identifying parathyroid glands (PGs) during total thyroidectomy (TTx) is better than surgeon's detection alone. It compares risk, benefits and outcomes in TTx patients where NIRAF detection with PTeye for parathyroid identification is either used or not used.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thyroid Neoplasms, Thyroid Diseases, Hypoparathyroidism, Endocrine System Diseases, Endocrine Gland Neoplasms, Neoplasms by Site, Neoplasms, Head and Neck Neoplasms, Parathyroid Diseases
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
Masking
Participant
Allocation
Randomized
Enrollment
160 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
PTeye
Arm Type
Experimental
Arm Description
The surgeon will use the PTeye as an intraoperative tool to identify if a suspect tissue is a parathyroid or not, during the total thyroidectomy procedure.
Arm Title
Standard of Care
Arm Type
No Intervention
Arm Description
The surgeon will not use the PTeye and will proceed with the total thyroidectomy as usual, while relying solely on her/his surgical experience in identifying the parathyroid glands during the operations.
Intervention Type
Device
Intervention Name(s)
PTeye
Intervention Description
The surgeon will first take 5 baseline NIRAF measurements on the thyroid gland (or neck muscle, if thyroid is absent) using the disposable sterile fiber probe that is connected to the PTeye console, as per device functionality requirements.
Primary Outcome Measure Information:
Title
Blood calcium levels
Time Frame
Before surgery (baseline)
Title
Blood calcium levels
Time Frame
Within 24 hours after surgery
Title
Blood parathyroid hormone (PTH) levels
Time Frame
Within 24 hours after surgery
Title
Blood parathyroid hormone (PTH) levels
Time Frame
5-14 days after surgery
Title
Blood parathyroid hormone (PTH) levels
Time Frame
6 months after surgery
Secondary Outcome Measure Information:
Title
Duration in minutes of surgery
Time Frame
Collected immediately following surgery
Title
Number of frozen section analysis performed(By case)
Time Frame
Collected immediately following surgery
Title
Percent of frozen sections confirmed as parathyroid tissue
Time Frame
Frozen results collected immediately after surgery.
Title
Permanent histology reports of all excised tissues
Time Frame
Permanent histology collected after report generated by pathologist (5-7 days)
Title
History of calcium and/or Vitamin D supplementation
Time Frame
Within 1 month prior to surgery (including daily dose)
Title
History of calcium and/or Vitamin D supplementation
Time Frame
up to 3 months after surgery (including daily dose)
Title
Duration of calcium and/or Vitamin D supplementation
Description
Duration measured in days
Time Frame
Within 1 month prior to surgery
Title
Duration of calcium and/or Vitamin D supplementation
Description
Duration measured in days
Time Frame
Up to 3 months after surgery
Title
Number of postsurgical complications
Description
Medical record review
Time Frame
Up to 3 months after surgery
Title
Frequency of Emergency Room (ER) visits or hospitalization due to low blood calcium within 30 days of surgery
Description
Medical record review
Time Frame
up to 30 days
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
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with thyroid disease who will be undergoing total thyroidectomy (includes patients who have undergone a prior neck exploration for parathyroid disease or other but have an intact thyroid gland). Patients with persisting thyroid disease and will be undergoing re-operative or completion thyroidectomy. Exclusion Criteria: Pregnant women Patients with concurrent parathyroid and thyroid disease Patients with incidental enlarged parathyroid discovered during thyroidectomy procedure. Patients undergoing thyroid lobectomy or partial thyroidectomy
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anee Sophia Jackson
Phone
734-647-1511
Email
aneesoph@med.umich.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul Gauger
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hunter Underwood
Phone
734-936-0231
Email
hunder@umich.edu
First Name & Middle Initial & Last Name & Degree
Paul Gauger

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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