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

Study Overview
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Brief Summary
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This study will see if 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 is better than a surgeon's detection alone. It compares risk-benefits and outcomes in PTx patients where NIRAF detection with PTeye for parathyroid identification is either used or not used.

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

Conditions
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Parathyroid Cancer, Parathyroid Adenoma, Parathyroid Neoplasms, Hypercalcemia, Primary Hyperparathyroidism

Intervention / Treatment
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* Device: PTeye


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Primary hyperparathyroidism who will be undergoing parathyroid surgery Persistent primary hyperparathyroidism after having undergone a failed prior parathyroid surgery who will be undergoing repeat parathyroid surgery Exclusion Criteria: Pregnant women (Those patients who could potentially will receive preoperative pregnancy testing, as is standard before general anesthesia. Any patients with positive pregnancy test results will not be included in the study.) Patients with concurrent parathyroid and thyroid disease that require total thyroidectomy Patients with secondary or tertiary hyperparathyroidism

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PTeye<br>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. | Device: PTeye<br>* The surgeon will first take 5 baseline NIRAF measurements on the thyroid gland (or neck muscle, if thyroid is absent) using the disposable sterile fiber probe that is connected to the PTeye console (see Figure 1), as per device functionality requirements.<br>|
| No Intervention: Standard of Care<br>The surgeon will rely solely on her/his surgical experience in identifying the parathyroid glands during the operations. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood calcium levels |  | Before surgery (baseline) | 
| Blood calcium levels |  | 5-14 days after surgery | 
| Blood calcium levels |  | 6 months after surgery | 
| Parathyroid hormone (PTH) levels | Intraoperative levels, (e.g. baseline, excision, 5 minutes). | Intraoperative levels (baseline, excision, 5 minutes) | 
| Parathyroid hormone (PTH) levels |  | 5-14 days after surgery | 
| Parathyroid hormone (PTH) levels |  | 6 months after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of Surgery in minutes |  | Collected immediately following surgery | 
| Number of frozen section analysis performed (by case) |  | Collected immediately following surgery | 
| Percent of frozen sections confirmed as parathyroid tissue |  | Frozen results collected immediately after surgery. | 
| Permanent histology - parathyroid tissue, cellularity, gland weight |  | Permanent histology collected after report generated by pathologist (5-7 days) | 
| Number of postsurgical complications | Medical record review | up to 30 days | 
| Frequency of postoperative (within 30 days) Emergency Room visits or hospitalization | Medical record review | up to 30 days | 
| Percent of repeat surgeries due to high calcium | Repeat surgeries are documented as binary (yes or no) | up to 6 months | 
| Average number of minutes taken to identify first parathyroid gland | Duration taken to identify 1st parathyroid gland in PTx procedure - timed from skin incision to finding parathyroid gland in each participant. | Immediate. During PTx procedure | 
| Average number of minutes taken to identify last parathyroid gland | Duration taken to identify last parathyroid gland in PTx procedure - timed from skin incision to finding the last parathyroid gland in each participant. | Immediate. During PTx procedure | 
| Minutes taken for intraoperative parathyroid hormone (PTH) to normalize | Time taken for PTH to attain cure criteria or normalize - timed from skin incision until the PTH levels drops > 50% of its baseline value and/or PTH drops < 65 pg/ml or 6.9 pmol/L. | Immediate. During PTx procedure. | 
| Number of nights spent in the hospital after parathyroidectomy | Number of nights spent for postoperative recovery in the hospital after the surgical procedure. | 0-72 hours after PTx procedure. | 
| Overall number of parathyroid glands identified. | Overall number of parathyroid glands identified (Experimental Group: Glands identified with naked eye + NIRAF; Control Group: Glands identified with naked eye) | Time Frame: Immediate. During total thyroidectomy procedure. | 
| Number of patients who have had repeat parathyroidectomy (PTx) procedure | Number of patients with repeat PTx procedure performed after the current procedure | 6 months after PTx procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Parathyroidectomy, Intraoperative Parathyroid Identification, Near Infrared Autofluorescence, Persistent Hyperparathyroidism, Persistent Hypercalcemia, Failed Parathyroidectomy, Repeat Parathyroidectomy