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

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.

Study Overview

• Status: Recruiting
• Conditions: Primary Hyperparathyroidism; Parathyroid Neoplasms; Hypercalcemia; Parathyroid Adenoma; Parathyroid Cancer
• Intervention / Treatment: Device: PTeye

• Study Type: Interventional
• Enrollment (Estimated): 160
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Anee Sophia Jackson; Phone Number: 734-647-1511; Email: aneesoph@med.umich.edu

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • Recruiting
      • The University of Michigan
      • Contact: Hunter Underwood; Phone Number: 734-936-0231; Email: hunder@umich.edu
      • Principal Investigator: Paul Gauger

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PTeye; 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.	Device: PTeye; 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.
No Intervention: Standard of Care; The surgeon will rely solely on her/his surgical experience in identifying the parathyroid glands during the operations.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood calcium levels		Before surgery (baseline)
Blood calcium levels		5-14 days after surgery
Blood calcium levels		6 months after surgery
Parathyroid hormone (PTH) levels	Intraoperative levels, (e.g. baseline, excision, 5 minutes).	Intraoperative levels (baseline, excision, 5 minutes)
Parathyroid hormone (PTH) levels		5-14 days after surgery
Parathyroid hormone (PTH) levels		6 months after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of nights spent in the hospital after parathyroidectomy	Number of nights spent for postoperative recovery in the hospital after the surgical procedure.	0-72 hours after PTx procedure.
Duration of Surgery in minutes		Collected immediately following surgery
Number of frozen section analysis performed (by case)		Collected immediately following surgery
Percent of frozen sections confirmed as parathyroid tissue		Frozen results collected immediately after surgery.
Permanent histology - parathyroid tissue, cellularity, gland weight		Permanent histology collected after report generated by pathologist (5-7 days)
Number of postsurgical complications	Medical record review	up to 30 days
Frequency of postoperative (within 30 days) Emergency Room visits or hospitalization	Medical record review	up to 30 days
Percent of repeat surgeries due to high calcium	Repeat surgeries are documented as binary (yes or no)	up to 6 months
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.	Immediate. During PTx procedure
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.	Immediate. During PTx procedure
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.	Immediate. During PTx 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)	Time Frame: Immediate. During total thyroidectomy procedure.
Number of patients who have had repeat parathyroidectomy (PTx) procedure	Number of patients with repeat PTx procedure performed after the current procedure	6 months after PTx procedure

Collaborators and Investigators

• Sponsor: University of Michigan
• Collaborators: National Cancer Institute (NCI); Vanderbilt University
• Investigators: Principal Investigator: Paul Gauger, University of Michigan

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2021
• Primary Completion (Estimated): August 1, 2024
• Study Completion (Estimated): August 1, 2024

Study Registration Dates

• First Submitted: August 22, 2021
• First Submitted That Met QC Criteria: August 22, 2021
• First Posted (Actual): August 26, 2021

Study Record Updates

• Last Update Posted (Actual): September 28, 2023
• Last Update Submitted That Met QC Criteria: September 27, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Near Infrared Autofluorescence; Parathyroidectomy; Intraoperative Parathyroid Identification; Persistent Hyperparathyroidism; Persistent Hypercalcemia; Failed Parathyroidectomy; Repeat Parathyroidectomy
• Additional Relevant MeSH Terms: Metabolic Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Endocrine System Diseases; Endocrine Gland Neoplasms; Parathyroid Diseases; Head and Neck Neoplasms; Calcium Metabolism Disorders; Water-Electrolyte Imbalance; Hyperparathyroidism; Hyperparathyroidism, Primary; Adenoma; Parathyroid Neoplasms; Hypercalcemia
• Other Study ID Numbers: HUM00192089; 5R01CA212147-02 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes