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Completed

NCT Number: NCT05152927

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Parathyroid Eye (PTeye)

Device

Intraoperative Tool

Other names: Near Infrared Autofluorescence (NIRAF), NIRAF detection modality, PTeye

Primary outcomes

  1. Median Number of Frozen Sections (or Parathyroid Aspirate) Sent for Analysis

    Time frame: At the end of the parathyroidectomy, up to 5 hours

    Median number of frozen sections (or aspirate) sent for analysis during the parathyroidectomy (PTx) procedure to confirm potential parathyroid tissue

Secondary outcomes

  1. Number of Participants With Persistent Hyperparathyroidism (Immediate)

    Time frame: 5-14 days after PTx procedure

    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.

  2. Number of Participants With Persistent Hyperparathyroidism or Hypercalcemia (Transient)

    Time frame: 5-14 days after PTx procedure

    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.

  3. Number of Participants Persistent Hyperparathyroidism or Hypercalcemia (Failed Parathyroidectomy)

    Time frame: Up to 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. Participants will be categorized has having persistent hyperparathyroidism or hypercalcemia (failed parathyroidectomy), Yes or No.

  4. Number of Parathyroid Glands (PG) Identified

    Time frame: At the end of the parathyroidectomy, up to 5 hours

    Overall number of parathyroid glands identified (Combined both the experimental Group (Glands identified with naked eye + NIRAF) and Control Group (Glands identified with naked eye)

  5. Median Number of Parathyroid Glands Identified With NIRAF (PTeye Group Only)

    Time frame: At the end of the parathyroidectomy, up to 5 hours

    Median number of parathyroid glands identified with NIRAF, which was not seen with surgeon's naked eye during bilateral neck explorations (where the surgeon is looking for more than 1 parathyroid gland)

  6. Median Number of Diseased Parathyroid Glands Identified Versus Preoperatively Localized Glands

    Time frame: At the end of the parathyroidectomy, up to 5 hours

    Median number of diseased parathyroid glands identified intra-operatively versus glands localized preoperatively using sestamibi, Computerized tomography (CT) or ultrasound

  7. Median Number of Intra-operative Parathyroid Hormone (PTH) Assays Sent

    Time frame: At the end of the parathyroidectomy, up to 5 hours

    The median number of intra-operative parathyroid hormone assays (per person) sent during the procedure to the lab

  8. Median Duration Taken to Identify First Parathyroid Gland

    Time frame: During parathyroidectomy, up to 5 hours

    Median duration in minutes taken to identify 1st parathyroid gland in PTx procedure - timed from skin incision to finding PG

  9. Median Duration Taken to Identify Last Parathyroid Gland

    Time frame: At the end of the parathyroidectomy, up to 5 hours

    Median duration taken to identify last parathyroid gland in PTx procedure - timed from skin incision to finding the last PG

  10. Median Duration of Parathyroidectomy (PTx) Procedure

    Time frame: Up to 5 hours

    Median duration of PTx procedure - timed from skin incision until the surgeon notifies the anesthesia team to awaken the patient in minutes

  11. Median Duration for Intraoperative Parathyroid Hormone (PTH) to Normalize

    Time frame: At the end of the parathyroidectomy, up to 5 hours

    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

  12. Median Number of Nights in the Hospital After Parathyroidectomy

    Time frame: 0-72 hours after PTx procedure

    Median number of nights spent in the hospital post-surgery is defined as having spent <= 23 hours (0 nights) or > 23 hours (1 night) at the hospital for postoperative recovery after the surgical procedure. Participants who had surgery scheduled for later in the day will be counted as spending one night in the hospital due to the minimum required observation period post-surgery and followed institutional standards for discharge; discharged the next day. Participants who had surgery scheduled for earlier in the day were discharged on the same day of surgery.

  13. Median Number of 'False Positive' Tissue Samples Excised by Surgeon

    Time frame: Up to 10 days after PTx procedure

    The median number of tissues per person that were excised by surgeon assumed to be parathyroid tissue, but is later validated as non-parathyroid tissue (false positive) by histology

  14. Number of Participants With Reported Doctor Visits/Emergency Department Visits or Hospital Admissions

    Time frame: Up to 6 months after PTx procedure

    Number of participants who required a doctor visit/emergency department visit and/or hospital admission due to persistent hypercalcemia and/or associated symptoms after the parathyroidectomy procedure will be categorized as binary (yes or no) if any follow-up visits or admissions occurred.

  15. Number of Participants Who Have Had Repeat Parathyroidectomy (PTx) Procedure

    Time frame: From 6 - 12 months after PTx procedure

    Number of participants with an indication that repeat PTx procedure may need to be performed after the current procedure will be categorized as binary (yes or no)

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Collaborators

  • National Cancer Institute (NCI)
  • Vanderbilt University Medical Center

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Dec 10, 2021
Registry last updated
Dec 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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