Clinical trial NCT04299425: Evaluating Impact of 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 Adenoma
Parathyroid Neoplasms
Parathyroid Hyperplasia
Parathyroid Cancer
Hypercalcemia
Primary Hyperparathyroidism
Keywords: Parathyroidectomy
Intraoperative Parathyroid Identification
Near Infrared Autofluorescence
Persistent Hyperparathyroidism
Persistent Hypercalcemia
Failed Parathyroidectomy
Repeat Parathyroidectomy
Lead sponsor: Vanderbilt-Ingram Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2020-03-06
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: NIRAF detection technology is used as an adjunctive tool for intraoperative parathyroid identification in patients who undergo parathyroidectomy (PTx) in the interventional group.

Generic Name of Device: Parathyroid Autofluorescence Detection Device (NIRAF detection technology).

The Parathyroid Autofluorescence Detection Device consists of a disposable fiber-optic probe that emits non-ionizing radiation from a near infrared (NIR) 785 nanometer (nm) laser source, and also transmits the resulting tissue NIRAF to a photo-detector. The 785 nm laser source emits a maximum power of 20 milliwatts (mW). The device has an FDA clearance for clinical use in general surgeries and dermatological use (Class 2 device).
Primary purpose: PREVENTION

Brief summary: This study describes a single center, randomized, single-blinded clinical trial to assess the clinical benefits of 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. 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: Inability of the surgeon to identify or localize the diseased PG can occur in 5 - 10% of cases resulting in failed parathyroidectomies (PTx). As a result, persistent hyperparathyroidism can occur in these patients resulting in unnecessary repeat surgeries that may be associated with increased morbidity and costs. Ultrasound imaging, 99mTechnetium-sestamibi scintigraphy, and computed tomography (CT) have so far demonstrated variable efficacy in preoperative localization of diseased PGs and may not always correlate well with the surgical field of view as observed intraoperatively. Consequently, most surgeons rely on visual identification of PGs during surgery, whereby the accuracy of PG identification is eventually determined by her/his surgical skill and experience. When in doubt, a surgeon routinely confirms the identity of PG tissue intraoperatively by sending the specimen for frozen section analysis that typically requires a wait time of 20-30 minutes per sample and has additional costs.

By easily being able to distinguish parathyroid from other tissues intraoperatively, postsurgical complications and associated costs may be reduced. The unique discovery of near infrared autofluorescence (NIRAF) in parathyroid tissues demonstrated that optical modalities that detect NIRAF can be utilized for non-invasive and label-free identification of parathyroid tissues with an accuracy as high as 97%. Since then, several research groups have explored the feasibility of localizing parathyroid glands using NIRAF detection with reasonable success, resulting in FDA clearance for marketing this optical technique. In this study, we plan to evaluate whether an FDA-cleared device called 'PTeye' (AiBiomed, Santa Barbara, CA) is beneficial or not, for the surgeon and patient during PTx operations. The results of such a study will help us to understand and assess the true impact of optical modalities such as PTeye on (i) improving the quality and efficiency of PTx surgeries and (ii) minimizing risk of postsurgical complications and related expenses.

The aim of this prospective single blinded randomized study is to compare 2 groups of patients: PTx patients operated using NIRAF detection technology with PTeye as adjunct tool (NIRAF+) vs. patients operated without the adjunct technology (NIRAF-). The main objective of this study is to assess the benefit of intraoperative use of NIRAF detection technology via PTeye during PTx procedures with regard to PG identification, duration of surgery, number of frozen section analysis performed, number of intraoperative PTH assays sent and incidence of postsurgical complications, if any and history of ER visits or hospitalization or repeat surgeries due to persistent high blood calcium after PTx procedure, compared to standard of care.

Eligibility criteria: Inclusion Criteria:

* All primary hyperparathyroidism patients eligible for parathyroidectomy (PTx). Both bilateral and focused mode of PTx will be considered for this study, based on the surgeon's preference.
* Re-operative primary hyperparathyroidism patients who have undergone a failed prior PTx.

Exclusion Criteria:

* Patients with concurrent parathyroid and thyroid disease that require total thyroidectomy.
* Patients with secondary or tertiary hyperparathyroidism.

Primary outcomes:
measure: Average Number of Parathyroid Glands Identified With High Confidence Per Patient
timeFrame: Immediate. During PTx procedure.
Secondary outcomes:
measure: Number of Participants With Persistent Hyperparathyroidism or Hypercalcemia (Failed Parathyroidectomy).
timeFrame: 6 months after PTx procedure
measure: Number of Frozen Sections Sent for Analysis
timeFrame: Immediate. During PTx procedure.
measure: Duration of Parathyroidectomy (PTx) Procedure
timeFrame: Immediate. During PTx procedure.
measure: Number of Participants Stratified by Duration of Hospital Stay
timeFrame: 0-72 hours after PTx procedure.
measure: Number of 'False Positive' Tissues Excised by Surgeon
timeFrame: Immediate to 10 days after PTx procedure.
measure: Number of Patients Who Have Had Repeat Parathyroidectomy (PTx) Procedure
timeFrame: At 6-months post-operation
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: Vanderbilt University Medical Center
name: Carmen C Solorzano, MD, FACS
role: PRINCIPAL_INVESTIGATOR
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