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

Not Applicable

Completed

• Conditions: Parathyroid Diseases; Hypercalcemia; Parathyroid Neoplasms; Neoplasms, Glandular and Epithelial; Endocrine Gland Neoplasms; Adenoma; Hyperparathyroidism, Primary; Parathyroid Dysfunction; Hyperparathyroidism; Parathyroid Adenoma
• Interventions: Device: Parathyroid Eye (PTeye)

• Registration Number: NCT05152927
• Lead Sponsor: University of California, San Francisco

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.

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.

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: 2021-11-29
• Study First Submitted QC: 2021-11-29
• Study First Posted: 2021-12-10
• Study Start: 2022-01-10
• Primary Completion: 2024-11-30
• Study Completion: 2024-11-30
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-10
• Last Update Posted: 2024-12-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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

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Exclusion Criteria

• Children and minors
• Pregnant women
• 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
Parathyroid Eye (PTeye)	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Number of participants with persistent hyperparathyroidism (Immediate)	1 day	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.
Median duration of parathyroidectomy (PTx) procedure	1 day	Median duration of PTx procedure - timed from skin incision until the surgeon notifies the anesthesia team to awaken the patient in minutes
Number of participants who have had repeat parathyroidectomy (PTx) procedure	From 6 - 12 months after PTx procedure	Number of patients with repeat PTx procedure performed after the current procedure will be categorized as binary (yes or no)
Number of participants with persistent hyperparathyroidism or hypercalcemia (transient)	5-14 days after PTx procedure	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.
Number of participants persistent hyperparathyroidism or hypercalcemia (failed parathyroidectomy)	Up to 6 months after PTx procedure	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.
Median number of intra-operative parathyroid hormone (PTH) assays sent	1 day	Median number of intra-operative parathyroid hormone assays per person sent during the procedure to the lab
Median duration taken to identify first parathyroid gland	1 day	Median duration in minutes taken to identify 1st parathyroid gland in PTx procedure - timed from skin incision to finding PG
Median number of 'false positive' tissues excised by surgeon	Up to 10 days after PTx procedure	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
Number of parathyroid glands (PG) identified	1 day	Overall number of parathyroid glands identified (Experimental Group: Glands identified with naked eye + NIRAF;Control Group: Glands identified with naked eye)
Median number of parathyroid glands identified with NIRAF	1 day	Median number of parathyroid glands identified with NIRAF, which was not seen with surgeon's naked eye
Number of participants with reported doctor visits/emergency department visits or hospital admissions	Up to 6 months after PTx procedure	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)
Median duration taken to identify last parathyroid gland	1 day	Median duration taken to identify last parathyroid gland in PTx procedure - timed from skin incision to finding the last PG
Median duration for intraoperative parathyroid hormone (PTH) to normalize	1 day	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
Median number of diseased parathyroid glands identified versus preoperatively localized glands	1 day	Median number of diseased parathyroid glands identified intra-operatively versus glands localized preoperatively using sestamibi, Computerized tomography (CT) or ultrasound
Median 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

Trial Locations

Locations (1)

University of California, San Francisco; 🇺🇸 San Francisco, California, United States