Evaluating Impact of NIRAF Detection for Identifying Parathyroid Glands During Parathyroidectomy

Not Applicable

Completed

Conditions: Parathyroid Neoplasms
Parathyroid Hyperplasia
Primary Hyperparathyroidism
Parathyroid Adenoma
Parathyroid Cancer
Hypercalcemia

Interventions: Device: NIRAF Detection Technology

Registration Number: NCT04299425

Lead Sponsor: Vanderbilt-Ingram Cancer Center

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 160

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NIRAF Detection Technology +	NIRAF Detection Technology	Parathyroid gland identification will be performed with PTeye using NIRAF detection technology as an adjunctive tool in patients who undergo parathyroidectomy (PTx).

Primary Outcome Measures

Name	Time	Method
Average Number of Parathyroid Glands Identified With High Confidence Per Patient	Immediate. During PTx procedure.	Average number of parathyroid glands identified (Experimental Group: Glands identified with naked eye + NIRAF; Control Group: Glands identified with naked eye) per patient

Secondary Outcome Measures

Name	Time	Method
Number of Participants Stratified by Duration of Hospital Stay	0-72 hours after PTx procedure.	Number of nights spent for postoperative recovery in the hospital after the surgical procedure.
Number of Frozen Sections Sent for Analysis	Immediate. During PTx procedure.	Number of frozen sections sent for analysis during the procedure to confirm potential parathyroid tissue
Number of Patients Who Have Had Repeat Parathyroidectomy (PTx) Procedure	At 6-months post-operation	Number of patients with repeat PTx procedure performed after the current procedure.
Duration of Parathyroidectomy (PTx) Procedure	Immediate. During PTx procedure.	Duration of PTx procedure - timed from skin incision until the surgeon notifies the anesthesia team to awaken the patient
Number of Participants With Persistent Hyperparathyroidism or Hypercalcemia (Failed Parathyroidectomy).	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.
Number of 'False Positive' Tissues Excised by Surgeon	Immediate to 10 days after PTx procedure.	Number of tissues that were excised by surgeon assumed to be parathyroid tissue, but is later validated as non-parathyroid tissue (false positive) by histology