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Evaluating Impact of Near Infrared Autofluorescence (NIRAF) Detection for Identifying Parathyroid Glands During Parathyroidectomy

Primary Purpose

Parathyroid Adenoma, Parathyroid Neoplasms, Parathyroid Cancer

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 Parathyroid Adenoma focused on measuring Parathyroidectomy, Intraoperative Parathyroid Identification, Near Infrared Autofluorescence, Persistent Hyperparathyroidism, Persistent Hypercalcemia, Failed Parathyroidectomy, Repeat Parathyroidectomy

Eligibility Criteria

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

Inclusion Criteria:

  • Primary hyperparathyroidism who will be undergoing parathyroid surgery
  • Persistent primary hyperparathyroidism after having undergone a failed prior parathyroid surgery who will be undergoing repeat parathyroid surgery

Exclusion Criteria:

  • Pregnant women (Those patients who could potentially will receive preoperative pregnancy testing, as is standard before general anesthesia. Any patients with positive pregnancy test results will not be included in the study.)
  • Patients with concurrent parathyroid and thyroid disease that require total thyroidectomy
  • Patients with secondary or tertiary hyperparathyroidism

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 parathyroid surgery.

The surgeon will rely 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 calcium levels
Parathyroid hormone (PTH) levels
Intraoperative levels, (e.g. baseline, excision, 5 minutes).
Parathyroid hormone (PTH) levels
Parathyroid hormone (PTH) levels

Secondary Outcome Measures

Duration of Surgery in minutes
Number of frozen section analysis performed (by case)
Percent of frozen sections confirmed as parathyroid tissue
Permanent histology - parathyroid tissue, cellularity, gland weight
Number of postsurgical complications
Medical record review
Frequency of postoperative (within 30 days) Emergency Room visits or hospitalization
Medical record review
Percent of repeat surgeries due to high calcium
Repeat surgeries are documented as binary (yes or no)
Average number of minutes taken to identify first parathyroid gland
Duration taken to identify 1st parathyroid gland in PTx procedure - timed from skin incision to finding parathyroid gland in each participant.
Average number of minutes taken to identify last parathyroid gland
Duration taken to identify last parathyroid gland in PTx procedure - timed from skin incision to finding the last parathyroid gland in each participant.
Minutes taken for intraoperative parathyroid hormone (PTH) to normalize
Time taken for PTH to attain cure criteria or normalize - timed from skin incision until the PTH levels drops > 50% of its baseline value and/or PTH drops < 65 pg/ml or 6.9 pmol/L.
Number of nights spent in the hospital after parathyroidectomy
Number of nights spent for postoperative recovery in the hospital after the surgical procedure.
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 patients who have had repeat parathyroidectomy (PTx) procedure
Number of patients with repeat PTx procedure performed after the current procedure

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
NCT05022641
Brief Title
Evaluating Impact of Near Infrared Autofluorescence (NIRAF) Detection for Identifying Parathyroid Glands During Parathyroidectomy
Official Title
Evaluating Impact of Near Infrared Autofluorescence (NIRAF) Detection for Identifying Parathyroid Glands During Parathyroidectomy
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

5. Study Description

Brief Summary
This study will see if the use of near infrared autofluorescence (NIRAF) detection with an FDA-cleared device 'Parathyroid Eye (PTeye)' for identifying parathyroid glands (PGs) during parathyroidectomy (PTx) procedures is better than a surgeon's detection alone. It compares risk-benefits and outcomes in PTx 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
Parathyroid Adenoma, Parathyroid Neoplasms, Parathyroid Cancer, Hypercalcemia, Primary Hyperparathyroidism
Keywords
Parathyroidectomy, Intraoperative Parathyroid Identification, Near Infrared Autofluorescence, Persistent Hyperparathyroidism, Persistent Hypercalcemia, Failed Parathyroidectomy, Repeat Parathyroidectomy

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Masking Description
Only participants will be masked to the intervention
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 parathyroid surgery.
Arm Title
Standard of Care
Arm Type
No Intervention
Arm Description
The surgeon will rely 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 (see Figure 1), as per device functionality requirements.
Primary Outcome Measure Information:
Title
Blood calcium levels
Time Frame
Before surgery (baseline)
Title
Blood calcium levels
Time Frame
5-14 days after surgery
Title
Blood calcium levels
Time Frame
6 months after surgery
Title
Parathyroid hormone (PTH) levels
Description
Intraoperative levels, (e.g. baseline, excision, 5 minutes).
Time Frame
Intraoperative levels (baseline, excision, 5 minutes)
Title
Parathyroid hormone (PTH) levels
Time Frame
5-14 days after surgery
Title
Parathyroid hormone (PTH) levels
Time Frame
6 months after surgery
Secondary Outcome Measure Information:
Title
Duration of Surgery in minutes
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 - parathyroid tissue, cellularity, gland weight
Time Frame
Permanent histology collected after report generated by pathologist (5-7 days)
Title
Number of postsurgical complications
Description
Medical record review
Time Frame
up to 30 days
Title
Frequency of postoperative (within 30 days) Emergency Room visits or hospitalization
Description
Medical record review
Time Frame
up to 30 days
Title
Percent of repeat surgeries due to high calcium
Description
Repeat surgeries are documented as binary (yes or no)
Time Frame
up to 6 months
Title
Average number of minutes taken to identify first parathyroid gland
Description
Duration taken to identify 1st parathyroid gland in PTx procedure - timed from skin incision to finding parathyroid gland in each participant.
Time Frame
Immediate. During PTx procedure
Title
Average number of minutes taken to identify last parathyroid gland
Description
Duration taken to identify last parathyroid gland in PTx procedure - timed from skin incision to finding the last parathyroid gland in each participant.
Time Frame
Immediate. During PTx procedure
Title
Minutes taken for intraoperative parathyroid hormone (PTH) to normalize
Description
Time taken for PTH to attain cure criteria or normalize - timed from skin incision until the PTH levels drops > 50% of its baseline value and/or PTH drops < 65 pg/ml or 6.9 pmol/L.
Time Frame
Immediate. During PTx procedure.
Title
Number of nights spent in the hospital after parathyroidectomy
Description
Number of nights spent for postoperative recovery in the hospital after the surgical procedure.
Time Frame
0-72 hours after PTx procedure.
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
Time Frame: Immediate. During total thyroidectomy procedure.
Title
Number of patients who have had repeat parathyroidectomy (PTx) procedure
Description
Number of patients with repeat PTx procedure performed after the current procedure
Time Frame
6 months after PTx procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Primary hyperparathyroidism who will be undergoing parathyroid surgery Persistent primary hyperparathyroidism after having undergone a failed prior parathyroid surgery who will be undergoing repeat parathyroid surgery Exclusion Criteria: Pregnant women (Those patients who could potentially will receive preoperative pregnancy testing, as is standard before general anesthesia. Any patients with positive pregnancy test results will not be included in the study.) Patients with concurrent parathyroid and thyroid disease that require total thyroidectomy Patients with secondary or tertiary hyperparathyroidism
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

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Evaluating Impact of Near Infrared Autofluorescence (NIRAF) Detection for Identifying Parathyroid Glands During Parathyroidectomy

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