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

NCT05022641 | Completed Results FDA Device

• 2 other identifiers: HUM001920895R01CA212147-02
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

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. Parathyroidectomy - look at application of the technology to see if it assists during a parathyroidectomy.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Average Number of Parathyroid Glands Identified

  Average number of parathyroid glands identified between the Experimental Group: Glands identified with naked eye + NIRAF vs. the Control Group: Glands identified with naked eye.

  Measured within the procedure, generally not more than 2 hours

Secondary Outcomes (5)

• Parathyroid Hormone (PTH) Levels 5-14 Days After Surgery

  5-14 days after surgery

• Appropriate Intraoperative Parathyroid Hormone Drop

  baseline to 10 minutes

• Duration of Surgery

  Measured within the procedure, generally not more than 2 hours

• Number of Nights Spent in the Hospital After Parathyroidectomy

  0-72 hours after PTx procedure.

• Number of Frozen Sections

  Immediate

Study Arms (2)

PTeye

EXPERIMENTAL

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

Standard of Care

OTHER

The surgeon will rely solely on her/his surgical experience in identifying the parathyroid glands during the operations.

Other: Standard of Care

Interventions

PTeye DEVICE

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.

PTeye

Standard of Care OTHER

The surgeon will rely solely on her/his surgical experience in identifying the parathyroid glands during the operations.

Standard of Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Michigan: lead
• National Cancer Institute (NCI): collaborator
• Vanderbilt University: collaborator

Study Sites (1)

The University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Related Publications (1)

• Cousart AG, Kiernan CM, Willmon PA, Thomas G, Wang TS, Gauger PG, Duh QY, Underwood HJ, Jackson A, Patel A, Mahadevan-Jansen A, Solorzano CC. Near-Infrared Autofluorescence for Parathyroid Detection During Endocrine Neck Surgery: A Randomized Clinical Trial. JAMA Surg. 2025 Sep 1;160(9):936-944. doi: 10.1001/jamasurg.2025.2233.

  PMID: 40668552 DERIVED

MeSH Terms

Conditions

Parathyroid Neoplasms; Hypercalcemia; Hyperparathyroidism, Primary

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Endocrine System Diseases; Parathyroid Diseases; Calcium Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Water-Electrolyte Imbalance; Hyperparathyroidism

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Limitations and Caveats

The relatively small sample size may miss rare events such as operative failure. Additionally, inter-variability amongst the two surgeons and their surgical approaches adds more complexity. Lastly, these findings may only be generalizable to higher volume centers with more experienced surgeons.

Results Point of Contact

• Title: Dr. Paul Gauger
• Organization: University of Michigan

pgauger@med.umich.edu

734-936-0231

Study Officials

• Paul Gauger

  University of Michigan

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Only participants will be masked to the intervention
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ambulatory Care Clinical Chief, William J Fry Professor of Surgery and Professor of Surgery, Medical School

Study Record Dates

• First Submitted: August 22, 2021
• First Posted: August 26, 2021
• Study Start: December 1, 2021
• Primary Completion: May 31, 2024
• Study Completion: May 31, 2024
• Last Updated: August 27, 2025
• Results First Posted: August 27, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)