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

Study Overview
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Brief Summary
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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
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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.

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 Diseases, Parathyroid Dysfunction, Parathyroid Neoplasms, Parathyroid Adenoma, Hypercalcemia, Neoplasms, Glandular and Epithelial, Endocrine Gland Neoplasms, Adenoma, Hyperparathyroidism, Hyperparathyroidism, Primary

Intervention / Treatment
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* Device: Parathyroid Eye (PTeye)


Participation Criteria
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Eligibility Criteria
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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

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: Parathyroid Eye (PTeye)<br>For patients assigned to the study arm, 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: Parathyroid Eye (PTeye)<br>* Intraoperative Tool<br>* Other names: PTeye;|
| No Intervention: Usual Standard of Care<br>The surgeon will proceed with the parathyroid surgery as usual, while relying 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 |
| --- | --- | --- |
| Median number of frozen sections (or PTH aspirate) sent for analysis | Number of frozen sections (or PTH aspirate) sent for analysis during the Parathyroidectomy (PTx) procedure to confirm potential parathyroid tissue | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with persistent hyperparathyroidism (Immediate) | Failure of intra-operative parathyroid hormone (PTH) to normalize (defined as failure of PTH to drop > 50% of its baseline value at final intra-operative PTH assay and/or failure of PTH to drop < 65 pg/ml or 6.9 pmol/L). Participants will be categorized as having persistent hyperparathyroidism (Immediate) Yes or No. | 1 day | 
| Number of participants with persistent hyperparathyroidism or hypercalcemia (transient) | Elevated blood calcium levels (total blood calcium level > 10.5 mg/dL or 2.6 mmol/L) with/without elevated parathyroid hormone (PTH) (serum intact PTH > 65 pg/ml or 6.9 pmol/L) at first postoperative visit. Participants will be categorized as having persistent hyperparathyroidism or hypercalcemia (transient) Yes or No. | 5-14 days after PTx procedure | 
| Number of participants persistent hyperparathyroidism or hypercalcemia (failed parathyroidectomy) | 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. Participants will be categorized has having persistent hyperparathyroidism or hypercalcemia (failed parathyroidectomy), Yes or No. | Up to 6 months after PTx procedure | 
| Number of parathyroid glands (PG) identified | Overall number of parathyroid glands identified (Experimental Group: Glands identified with naked eye + NIRAF;Control Group: Glands identified with naked eye) | 1 day | 
| Median number of parathyroid glands identified with NIRAF | Median number of parathyroid glands identified with NIRAF, which was not seen with surgeon's naked eye | 1 day | 
| Median number of diseased parathyroid glands identified versus preoperatively localized glands | Median number of diseased parathyroid glands identified intra-operatively versus glands localized preoperatively using sestamibi, Computerized tomography (CT) or ultrasound | 1 day | 
| Median number of intra-operative parathyroid hormone (PTH) assays sent | Median number of intra-operative parathyroid hormone assays per person sent during the procedure to the lab | 1 day | 
| Median duration taken to identify first parathyroid gland | Median duration in minutes taken to identify 1st parathyroid gland in PTx procedure - timed from skin incision to finding PG | 1 day | 
| Median duration taken to identify last parathyroid gland | Median duration taken to identify last parathyroid gland in PTx procedure - timed from skin incision to finding the last PG | 1 day | 
| Median duration of parathyroidectomy (PTx) procedure | Median duration of PTx procedure - timed from skin incision until the surgeon notifies the anesthesia team to awaken the patient in minutes | 1 day | 
| Median duration for intraoperative parathyroid hormone (PTH) to normalize | Median time in minutes 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 | 1 day | 
| Median 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 | 
| Median number of 'false positive' tissues excised by surgeon | Median number of tissues per person that were excised by surgeon assumed to be parathyroid tissue, but is later validated as nonparathyroid tissue (false positive) by histology | Up to 10 days after PTx procedure | 
| Number of participants with reported doctor visits/emergency department visits or hospital admissions | Number of doctor visits/emergency department visits or hospital admissions due to persistent hypercalcemia and/or associated symptoms after parathyroidectomy procedure will be categorized as binary (yes or no) | Up to 6 months after PTx procedure | 
| Number of participants who have had repeat parathyroidectomy (PTx) procedure | Number of patients with repeat PTx procedure performed after the current procedure will be categorized as binary (yes or no) | From 6 - 12 months after PTx procedure | 

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