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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Neoplasms, Glandular and Epithelial; Endocrine Gland Neoplasms; Hyperparathyroidism; Hyperparathyroidism, Primary; Parathyroid Diseases; Adenoma; Parathyroid Neoplasms; Hypercalcemia; Parathyroid Adenoma; Parathyroid Dysfunction
• Intervention / Treatment: Device: Parathyroid Eye (PTeye)

Detailed Description

This is a prospective, single-blinded, randomized study comparing the use of PTeye during parathyroidectomy to usual standard practice.

PRIMARY OBJECTIVES:

I. Assess the impact of PTeye on intra-operative identification of parathyroid tissues.

II. Assess the impact of PTeye on improving efficiency of parathyroid surgeries.

III. Assess the impact of PTeye on minimizing risk of post-surgical complications.

Participants will be randomized to either the experimental or control arm.

The surgeon will first take 5 baseline NIRAF measurements on the thyroid gland (or neck muscles, if thyroid is absent) using the disposable sterile fiber probe that is connected to the PTeye console, as per device functionality requirements. The subsequent step would involve touching the target tissue in the neck with the fiber optic probe, following which the PTeye will indicate to the surgeon if the tissue is likely parathyroid or not.

For patients assigned to the control arm, the surgeon will not use the PTeye and will proceed with the parathyroid surgery as usual, while relying solely on her/his surgical experience in identifying the parathyroid glands during the operations.

Participants will be follow-ed up for up to 6 months after surgery.

• Study Type: Interventional
• Enrollment (Estimated): 110
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Brandon Yap; Phone Number: 877-827-3222; Email: Brandon.Yap@ucsf.edu

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94143
      • Recruiting
      • University of California, San Francisco
      • Contact: Brandon Yap; Email: Brandon.Yap@ucsf.edu
      • Principal Investigator: Quan-Yang Duh, MD, FACS

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• Children and minors
• Pregnant women
• 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: Parathyroid Eye (PTeye); 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); Intraoperative Tool; Other Names: Near Infrared Autofluorescence (NIRAF); NIRAF detection modality; PTeye
No Intervention: Usual Standard of Care; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Median number of frozen sections (or PTH aspirate) sent for analysis	Number of frozen sections (or PTH aspirate) sent for analysis during the Parathyroidectomy (PTx) procedure to confirm potential parathyroid tissue	1 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with persistent hyperparathyroidism (Immediate)	Failure of intra-operative parathyroid hormone (PTH) to normalize (defined as failure of PTH to drop > 50% of its baseline value at final intra-operative PTH assay and/or failure of PTH to drop < 65 pg/ml or 6.9 pmol/L). Participants will be categorized as having persistent hyperparathyroidism (Immediate) Yes or No.	1 day
Number of participants with persistent hyperparathyroidism or hypercalcemia (transient)	Elevated blood calcium levels (total blood calcium level > 10.5 mg/dL or 2.6 mmol/L) with/without elevated parathyroid hormone (PTH) (serum intact PTH > 65 pg/ml or 6.9 pmol/L) at first postoperative visit. Participants will be categorized as having persistent hyperparathyroidism or hypercalcemia (transient) Yes or No.	5-14 days after PTx procedure
Number of participants persistent hyperparathyroidism or hypercalcemia (failed parathyroidectomy)	If blood calcium with/without parathyroid hormone (PTH) has not normalized at 1st post-operative visit, calcium and/or PTH is subsequently measured as necessary. Patient is defined to have a failed parathyroidectomy if hypercalcemia/hyperparathyroidism (defined as total blood calcium level > 10.5 mg/dL or 2.6 mmol/L, with/without elevated serum intact PTH > 65 pg/ml or 6.9 pmol/L) persists at or after the 6th postoperative month. Participants will be categorized has having persistent hyperparathyroidism or hypercalcemia (failed parathyroidectomy), Yes or No.	Up to 6 months after PTx procedure
Number of parathyroid glands (PG) identified	Overall number of parathyroid glands identified (Experimental Group: Glands identified with naked eye + NIRAF;Control Group: Glands identified with naked eye)	1 day
Median number of parathyroid glands identified with NIRAF	Median number of parathyroid glands identified with NIRAF, which was not seen with surgeon's naked eye	1 day
Median number of diseased parathyroid glands identified versus preoperatively localized glands	Median number of diseased parathyroid glands identified intra-operatively versus glands localized preoperatively using sestamibi, Computerized tomography (CT) or ultrasound	1 day
Median number of intra-operative parathyroid hormone (PTH) assays sent	Median number of intra-operative parathyroid hormone assays per person sent during the procedure to the lab	1 day
Median duration taken to identify first parathyroid gland	Median duration in minutes taken to identify 1st parathyroid gland in PTx procedure - timed from skin incision to finding PG	1 day
Median duration taken to identify last parathyroid gland	Median duration taken to identify last parathyroid gland in PTx procedure - timed from skin incision to finding the last PG	1 day
Median duration of parathyroidectomy (PTx) procedure	Median duration of PTx procedure - timed from skin incision until the surgeon notifies the anesthesia team to awaken the patient in minutes	1 day
Median duration for intraoperative parathyroid hormone (PTH) to normalize	Median time in minutes 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	1 day
Median 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
Median number of 'false positive' tissues excised by surgeon	Median number of tissues per person that were excised by surgeon assumed to be parathyroid tissue, but is later validated as nonparathyroid tissue (false positive) by histology	Up to 10 days after PTx procedure
Number of participants with reported doctor visits/emergency department visits or hospital admissions	Number of doctor visits/emergency department visits or hospital admissions due to persistent hypercalcemia and/or associated symptoms after parathyroidectomy procedure will be categorized as binary (yes or no)	Up to 6 months after PTx procedure
Number of participants who have had repeat parathyroidectomy (PTx) procedure	Number of patients with repeat PTx procedure performed after the current procedure will be categorized as binary (yes or no)	From 6 - 12 months after PTx procedure

Collaborators and Investigators

• Sponsor: University of California, San Francisco
• Collaborators: National Cancer Institute (NCI); Vanderbilt University Medical Center
• Investigators: Principal Investigator: Quan-Yang Duh, MD, FACS, University of California, San Francisco

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 10, 2022
• Primary Completion (Estimated): January 31, 2025
• Study Completion (Estimated): January 31, 2025

Study Registration Dates

• First Submitted: November 29, 2021
• First Submitted That Met QC Criteria: November 29, 2021
• First Posted (Actual): December 10, 2021

Study Record Updates

• Last Update Posted (Actual): August 16, 2023
• Last Update Submitted That Met QC Criteria: August 15, 2023
• Last Verified: August 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 by Site; Endocrine System Diseases; Head and Neck Neoplasms; Calcium Metabolism Disorders; Water-Electrolyte Imbalance; Neoplasms; Hyperparathyroidism; Hyperparathyroidism, Primary; Adenoma; Neoplasms, Glandular and Epithelial; Endocrine Gland Neoplasms; Parathyroid Neoplasms; Parathyroid Diseases; Hypercalcemia; Physiological Effects of Drugs; Calcium-Regulating Hormones and Agents; Parathyroid Hormone
• Other Study ID Numbers: 21208; 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