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

University of California San Francisco (UCSF)

Status: Completed

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

Treatments: Device: Parathyroid Eye (PTeye)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05152927

5R01CA212147-02 (U.S. NIH Grant/Contract)

21208

Details and patient eligibility

About

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.

Full 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.

Enrollment: 79 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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79 participants in 2 patient groups

Parathyroid Eye (PTeye)

Experimental group

Description:

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.

Treatment:

Device: Parathyroid Eye (PTeye)

Usual Standard of Care

No Intervention group

Description:

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.