Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCSF
Dates
study started
estimated completion
Principal Investigator
by Quan-Yang Duh, MD, FACS (ucsf)
Headshot of Quan-Yang Duh
Quan-Yang Duh

Description

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.

Official Title

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

Details

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.

Keywords

Parathyroid Diseases Parathyroid Dysfunction Parathyroid Neoplasms Parathyroid Adenoma Hypercalcemia Neoplasms, Glandular and Epithelial Endocrine Gland Neoplasms Adenoma Hyperparathyroidism Hyperparathyroidism, Primary Near Infrared Autofluorescence Parathyroidectomy Intraoperative Parathyroid Identification Persistent Hyperparathyroidism Persistent Hypercalcemia Failed Parathyroidectomy Repeat Parathyroidectomy Neoplasms Parathyroid Hormone Parathyroid Eye (PTeye)

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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

You CAN'T join if...

  • Children and minors
  • Pregnant women
  • Patients with concurrent parathyroid and thyroid disease that require total thyroidectomy
  • Patients with secondary or tertiary hyperparathyroidism

Location

  • University of California, San Francisco accepting new patients
    San Francisco California 94143 United States

Lead Scientist at UC Cancer

  • Quan-Yang Duh, MD, FACS (ucsf)
    Professor, Surgery, School of Medicine. Authored (or co-authored) 416 research publications

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Francisco
ID
NCT05152927
Study Type
Interventional
Last Updated