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

NCT05152927 | Completed Results FDA Device

• 2 other identifiers: 212085R01CA212147-02
• Study Type: interventional
• Target: 79
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this study is to assess whether using PTeye (AiBiomed, Santa Barbara, CA) - a NIRAF detection modality - can improve patient outcomes and reduce healthcare associated costs after parathyroid surgeries. By being able to quickly and definitively locate parathyroid glands while in the operating room, the duration of surgical procedure could be further reduced. In addition, the number of frozen section biopsy and associated costs can be minimized. Furthermore, repeat surgeries as a result of missing a diseased parathyroid gland at the time of the initial parathyroidectomy for hyperparathyroidism could potentially be avoided.

Conditions

Parathyroid Neoplasms; Hypercalcemia; Neoplasms, Glandular and Epithelial; Endocrine Gland Neoplasms; Adenoma; Hyperparathyroidism; Hyperparathyroidism, Primary; Parathyroid Diseases; Parathyroid Dysfunction; Parathyroid Adenoma

Keywords

Near Infrared Autofluorescence; Parathyroidectomy; Intraoperative Parathyroid Identification; Persistent Hyperparathyroidism; Persistent Hypercalcemia; Failed Parathyroidectomy; Repeat Parathyroidectomy

Outcome Measures

Primary Outcomes (1)

• Median Number of Frozen Sections (or Parathyroid Aspirate) Sent for Analysis

  Median number of frozen sections (or aspirate) sent for analysis during the parathyroidectomy (PTx) procedure to confirm potential parathyroid tissue

  At the end of the parathyroidectomy, up to 5 hours

Secondary Outcomes (15)

• Number of Participants With Persistent Hyperparathyroidism (Immediate)

  5-14 days after PTx procedure

• Number of Participants With Persistent Hyperparathyroidism or Hypercalcemia (Transient)

  5-14 days after PTx procedure

• Number of Participants Persistent Hyperparathyroidism or Hypercalcemia (Failed Parathyroidectomy)

  Up to 6 months after PTx procedure

• Number of Parathyroid Glands (PG) Identified

  At the end of the parathyroidectomy, up to 5 hours

• Median Number of Parathyroid Glands Identified With NIRAF (PTeye Group Only)

  At the end of the parathyroidectomy, up to 5 hours

Study Arms (2)

Parathyroid Eye (PTeye)

EXPERIMENTAL

For patients assigned to the study arm, 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: Parathyroid Eye (PTeye)

Usual Standard of Care

NO INTERVENTION

The surgeon will proceed with the parathyroid surgery as usual, while relying solely on her/his surgical experience in identifying the parathyroid glands during the operations.

Interventions

Parathyroid Eye (PTeye) DEVICE

Intraoperative Tool

Also known as: Near Infrared Autofluorescence (NIRAF), NIRAF detection modality, PTeye

Parathyroid Eye (PTeye)

Eligibility Criteria

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

You may qualify if:

• All adults \>=18 years old) patients with primary hyperparathyroidism who will be undergoing parathyroid surgery
• All adult (\>=18 years old) patients with persistent primary hyperparathyroidism after having undergone a failed prior parathyroid surgery who will be undergoing repeat parathyroid surgery

You may not qualify if:

• Children and minors
• Pregnant women
• Patients with concurrent parathyroid and thyroid disease that require total thyroidectomy
• Patients with secondary or tertiary hyperparathyroidism

Sponsors & Collaborators

• University of California, San Francisco: lead
• Vanderbilt University Medical Center: collaborator
• National Cancer Institute (NCI): collaborator

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94143, United States

Location

Related Publications (3)

• McWade MA, Paras C, White LM, Phay JE, Mahadevan-Jansen A, Broome JT. A novel optical approach to intraoperative detection of parathyroid glands. Surgery. 2013 Dec;154(6):1371-7; discussion 1377. doi: 10.1016/j.surg.2013.06.046.

  PMID: 24238054 BACKGROUND

• Thomas G, Solorzano CC, Baregamian N, Mannoh EA, Gautam R, Irlmeier RT, Ye F, Nelson JA, Long SE, Gauger PG, Magner A, Metcalf T, Shirley LA, Phay JE, Mahadevan-Jansen A. Comparing intraoperative parathyroid identification based on surgeon experience versus near infrared autofluorescence detection - A surgeon-blinded multi-centric study. Am J Surg. 2021 Nov;222(5):944-951. doi: 10.1016/j.amjsurg.2021.05.001. Epub 2021 May 13.

  PMID: 34024629 BACKGROUND

• 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 Diseases; Parathyroid Neoplasms; Hypercalcemia; Neoplasms, Glandular and Epithelial; Endocrine Gland Neoplasms; Adenoma; Hyperparathyroidism; Hyperparathyroidism, Primary

Condition Hierarchy (Ancestors)

Endocrine System Diseases; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Calcium Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Water-Electrolyte Imbalance; Neoplasms by Histologic Type

Results Point of Contact

• Title: Dr. Quan-Yang Duh, MD
• Organization: University of California, San Francisco

quan-yang.duh@ucsf.edu

(415) 221-4810

Study Officials

• Quan-Yang Duh, MD, FACS

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

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: SPONSOR

Study Record Dates

• First Submitted: November 29, 2021
• First Posted: December 10, 2021
• Study Start: January 10, 2022
• Primary Completion: November 30, 2024
• Study Completion: November 30, 2024
• Last Updated: December 15, 2025
• Results First Posted: December 15, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)