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

Not Applicable

Completed

• Conditions: Parathyroid Cancer; Hypercalcemia; Parathyroid Adenoma; Primary Hyperparathyroidism; Parathyroid Neoplasms

• Registration Number: NCT05022641
• Lead Sponsor: University of Michigan

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.

Detailed Description

Prior to data collection, it was determined some additional outcome measures collected by the primary site would not be relevant to the trial for participating sites such as this site. Those outcomes were removed from this record.

Study Timeline

• Study First Submitted: 2021-08-22
• Study First Submitted QC: 2021-08-22
• Study First Posted: 2021-08-26
• Study Start: 2021-12-01
• Disposition First Posted: 2023-09-28
• Primary Completion: 2024-05-31
• Study Completion: 2024-05-31
• Disposition First Submitted: 2025-05-30
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-11
• Last Update Posted: 2025-07-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 160

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Average Number of Parathyroid Glands Identified	Measured within the procedure, generally not more than 2 hours	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.

Secondary Outcome Measures

Name	Time	Method
Parathyroid Hormone (PTH) Levels 5-14 Days After Surgery	5-14 days after surgery	Parathyroid hormone (PTH) levels 5-14 days after surgery. Higher levels could indicate failure of operation. Low levels could indicate temporary or permanent parathyroid damage.
Appropriate Intraoperative Parathyroid Hormone Drop	baseline to 10 minutes	\>50% drop from baseline at 10 minutes post-resection
Duration of Surgery in Minutes	Measured within the procedure, generally not more than 2 hours	Surgery duration in minutes
Number of Nights Spent in the Hospital After Parathyroidectomy	0-72 hours after PTx procedure	Number of nights spent for postoperative recovery in the hospital after the surgical procedure.
Number of Frozen Sections	total number of frozen sections sent to confirm parathyroid gland identity, immediate.	Total number of frozen sections conducted for patients undergoing repeat surgery or bilateral neck explorations. Frozen sections were conducted to confirm that the parathyroid tissue for the targeted over-acting parathyroid was removed. Results reflect whether participants had a frozen section conducted.

Trial Locations

Locations (1)

The University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States