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

Not Applicable

Recruiting

• Conditions: Parathyroid Cancer; Hypercalcemia; Parathyroid Adenoma; Primary Hyperparathyroidism; Parathyroid Neoplasms
• Interventions: Device: PTeye

• 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

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
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-27
• Last Update Posted: 2023-09-28
• Primary Completion: 2024-08
• Study Completion: 2024-08

Recruitment & Eligibility

• Status: RECRUITING
• 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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PTeye	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.

Primary Outcome Measures

Name	Time	Method
Parathyroid hormone (PTH) levels	6 months after surgery
Blood calcium levels	6 months after surgery

Secondary Outcome Measures

Name	Time	Method
Percent of repeat surgeries due to high calcium	up to 6 months	Repeat surgeries are documented as binary (yes or no)
Frequency of postoperative (within 30 days) Emergency Room visits or hospitalization	up to 30 days	Medical record review
Average number of minutes taken to identify first parathyroid gland	Immediate. During PTx procedure	Duration taken to identify 1st parathyroid gland in PTx procedure - timed from skin incision to finding parathyroid gland in each participant.
Permanent histology - parathyroid tissue, cellularity, gland weight	Permanent histology collected after report generated by pathologist (5-7 days)
Average number of minutes taken to identify last parathyroid gland	Immediate. During PTx procedure	Duration taken to identify last parathyroid gland in PTx procedure - timed from skin incision to finding the last parathyroid gland in each participant.
Minutes taken for intraoperative parathyroid hormone (PTH) to normalize	Immediate. During PTx procedure.	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.
Number of patients who have had repeat parathyroidectomy (PTx) procedure	6 months after PTx procedure	Number of patients with repeat PTx procedure performed after the current procedure
Number of frozen section analysis performed (by case)	Collected immediately following surgery
Number of postsurgical complications	up to 30 days	Medical record review
Duration of Surgery in minutes	Collected immediately following surgery
Percent of frozen sections confirmed as parathyroid tissue	Frozen results collected immediately after surgery.
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.
Overall number of parathyroid glands identified.	Time Frame: Immediate. During total thyroidectomy procedure.	Overall number of parathyroid glands identified (Experimental Group: Glands identified with naked eye + NIRAF; Control Group: Glands identified with naked eye)

Trial Locations

Locations (1)

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