Clinical trial NCT05152927: Near Infrared Autofluorescence (NIRAF) Detection for Identifying Parathyroid Glands During Parathyroidectomy
Official title: Evaluating Impact of Near Infrared Autofluorescence (NIRAF) Detection for Identifying Parathyroid Glands During Parathyroidectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parathyroid Diseases
Parathyroid Dysfunction
Parathyroid Neoplasms
Parathyroid Adenoma
Hypercalcemia
Neoplasms, Glandular and Epithelial
Endocrine Gland Neoplasms
Adenoma
Hyperparathyroidism
Hyperparathyroidism, Primary
Keywords: Near Infrared Autofluorescence
Parathyroidectomy
Intraoperative Parathyroid Identification
Persistent Hyperparathyroidism
Persistent Hypercalcemia
Failed Parathyroidectomy
Repeat Parathyroidectomy
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: Vanderbilt University Medical Center
name: National Cancer Institute (NCI)
First posted: 2021-12-10
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Median number of frozen sections (or PTH aspirate) sent for analysis
timeFrame: 1 day
Secondary outcomes:
measure: Number of participants with persistent hyperparathyroidism (Immediate)
timeFrame: 1 day
measure: Number of participants with persistent hyperparathyroidism or hypercalcemia (transient)
timeFrame: 5-14 days after PTx procedure
measure: Number of participants persistent hyperparathyroidism or hypercalcemia (failed parathyroidectomy)
timeFrame: Up to 6 months after PTx procedure
measure: Number of parathyroid glands (PG) identified
timeFrame: 1 day
measure: Median number of parathyroid glands identified with NIRAF
timeFrame: 1 day
measure: Median number of diseased parathyroid glands identified versus preoperatively localized glands
timeFrame: 1 day
measure: Median number of intra-operative parathyroid hormone (PTH) assays sent
timeFrame: 1 day
measure: Median duration taken to identify first parathyroid gland
timeFrame: 1 day
measure: Median duration taken to identify last parathyroid gland
timeFrame: 1 day
measure: Median duration of parathyroidectomy (PTx) procedure
timeFrame: 1 day
measure: Median duration for intraoperative parathyroid hormone (PTH) to normalize
timeFrame: 1 day
measure: Median number of nights spent in the hospital after parathyroidectomy
timeFrame: 0-72 hours after PTx procedure
measure: Median number of 'false positive' tissues excised by surgeon
timeFrame: Up to 10 days after PTx procedure
measure: Number of participants with reported doctor visits/emergency department visits or hospital admissions
timeFrame: Up to 6 months after PTx procedure
measure: Number of participants who have had repeat parathyroidectomy (PTx) procedure
timeFrame: From 6 - 12 months after PTx procedure
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Quan-Yang Duh, MD, FACS
role: PRINCIPAL_INVESTIGATOR
References:
citation: McWade MA, Paras C, White LM, Phay JE, Mahadevan-Jansen A, Broome JT. A novel optical approach to intraoperative detection of parathyroid glands. Surgery. 2013 Dec;154(6):1371-7; discussion 1377. doi: 10.1016/j.surg.2013.06.046.
citation: Thomas G, Solorzano CC, Baregamian N, Mannoh EA, Gautam R, Irlmeier RT, Ye F, Nelson JA, Long SE, Gauger PG, Magner A, Metcalf T, Shirley LA, Phay JE, Mahadevan-Jansen A. Comparing intraoperative parathyroid identification based on surgeon experience versus near infrared autofluorescence detection - A surgeon-blinded multi-centric study. Am J Surg. 2021 Nov;222(5):944-951. doi: 10.1016/j.amjsurg.2021.05.001. Epub 2021 May 13.