University of California, San Francisco
San Francisco, California, 94143, United States
NCT Number: NCT05152927
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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Notify Me18 year and older
All sexes
Interventional
Not applicable
San Francisco, California, 94143, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Intraoperative Tool
Other names: Near Infrared Autofluorescence (NIRAF), NIRAF detection modality, PTeye
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
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.
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.
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.
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)
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)
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
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
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
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
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
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
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.
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
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.
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)
University of California, San Francisco
Other
Evaluating Impact of Near Infrared Autofluorescence (NIRAF) Detection for Identifying Parathyroid Glands During Parathyroidectomy
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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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