An interventional study of NIRAF Detection Technology in Parathyroid Adenoma, Parathyroid Neoplasms and Parathyroid Hyperplasia, sponsored by Vanderbilt-Ingram Cancer Center. Completed at 1 site in United States. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2024-05-13.
Sponsored by Vanderbilt-Ingram Cancer Center · Not applicable, Interventional, and Prevention
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.
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.
63 studies on the registry are indexed under Parathyroid Neoplasms; 19 are open to participants now.
This study's enrollment of 160 is above the median of 60 across 38 interventional studies indexed under Parathyroid Neoplasms.
Browse Parathyroid Neoplasms studies →Vanderbilt-Ingram Cancer Center is the lead sponsor of 223 studies on the registry; 33 are open to participants now.
Of its 23 completed or terminated interventional studies of FDA-regulated products, 18 (78%) have results posted.
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Exclusion Criteria:
Parathyroid gland identification will be performed with PTeye using NIRAF detection technology as an adjunctive tool in patients who undergo parathyroidectomy (PTx).
Device: NIRAF Detection Technology
Parathyroid gland identification will be performed with the naked eye of the surgeon without using PTeye - NIRAF detection technology in patients who undergo parathyroidectomy (PTx).
Near Infrared Autofluorescence (NIRAF) detection technology or 'PTeye' consists of a disposable fiber-optic probe that emits non-ionizing radiation from a NIR 785 nm laser source, and also transmits the resulting tissue NIRAF to a photo detector. The 785 nm laser source emits a maximum power of 20 mW. The device is FDA cleared for clinical use in general surgeries and dermatological use (Class 2 device). After surgeon identifies a potential parathyroid gland in the surgical field, the surgeon places the fiber-optic probe of PTeye on suspect tissue and presses the device foot-pedal to activate tissue NIRAF measurement. Auditory beep at high frequency with a Detection Ratio \> 1.2 is interpreted by device as the suspect tissue being positive for parathyroid.
Also known as: PTeye Device
Average Number of Parathyroid Glands Identified With High Confidence Per Patient
Average number of parathyroid glands identified (Experimental Group: Glands identified with naked eye + NIRAF; Control Group: Glands identified with naked eye) per patient
Time frame: Immediate. During PTx procedure.
Number of Participants With 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.
Time frame: 6 months after PTx procedure
Number of Frozen Sections Sent for Analysis
Number of frozen sections sent for analysis during the procedure to confirm potential parathyroid tissue
Time frame: Immediate. During PTx procedure.
Duration of Parathyroidectomy (PTx) Procedure
Duration of PTx procedure - timed from skin incision until the surgeon notifies the anesthesia team to awaken the patient
Time frame: Immediate. During PTx procedure.
Number of Participants Stratified by Duration of Hospital Stay
Number of nights spent for postoperative recovery in the hospital after the surgical procedure.
Time frame: 0-72 hours after PTx procedure.
Number of 'False Positive' Tissues Excised by Surgeon
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
Time frame: Immediate to 10 days after PTx procedure.
Number of Patients Who Have Had Repeat Parathyroidectomy (PTx) Procedure
Number of patients with repeat PTx procedure performed after the current procedure.
Time frame: At 6-months post-operation
| Milestone | NIRAF Detection Technology + | NIRAF Detection Technology - |
|---|---|---|
| Started | 80 | 80 |
| Completed | 80 | 80 |
| Not completed | 0 | 0 |
Average number of parathyroid glands identified (Experimental Group: Glands identified with naked eye + NIRAF; Control Group: Glands identified with naked eye) per patient
| parathyroid glands | NIRAF Detection Technology + | NIRAF Detection Technology - |
|---|---|---|
| Average Number of Parathyroid Glands Identified With High Confidence Per Patient | 3.1 ± 1.21 | 2.7 ± 1.13 |
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 | NIRAF Detection Technology + | NIRAF Detection Technology - |
|---|---|---|
| Number of Participants With Persistent Hyperparathyroidism or Hypercalcemia (Failed Parathyroidectomy). | 0 | 1 |
Number of frozen sections sent for analysis during the procedure to confirm potential parathyroid tissue
| frozen sections | NIRAF Detection Technology + | NIRAF Detection Technology - |
|---|---|---|
| Number of Frozen Sections Sent for Analysis | 13 | 45 |
Duration of PTx procedure - timed from skin incision until the surgeon notifies the anesthesia team to awaken the patient
| minutes | NIRAF Detection Technology + | NIRAF Detection Technology - |
|---|---|---|
| Duration of Parathyroidectomy (PTx) Procedure | 89.3 ± 32.6 | 95.5 ± 39.7 |
Number of nights spent for postoperative recovery in the hospital after the surgical procedure.
| Participants | NIRAF Detection Technology + | NIRAF Detection Technology - |
|---|---|---|
| Discharged same day | 64 | 66 |
| Overnight | 14 | 14 |
| Admitted > 23 hours | 2 | 0 |
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
| false positives | NIRAF Detection Technology + |
|---|---|
| Number of 'False Positive' Tissues Excised by Surgeon | 19 |
Number of patients with repeat PTx procedure performed after the current procedure.
| Participants | NIRAF Detection Technology + | NIRAF Detection Technology - |
|---|---|---|
| Number of Patients Who Have Had Repeat Parathyroidectomy (PTx) Procedure | 0 | 1 |
Collected over Adverse event data was collected for 2 years, 5 months.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| NIRAF Detection Technology + | 0/80 (0%) | 0/80 (0%) | 0/80 (0%) |
| NIRAF Detection Technology - | 0/80 (0%) | 0/80 (0%) | 0/80 (0%) |
| Age, Continuous(years) | NIRAF Detection Technology + | NIRAF Detection Technology - | Total |
|---|---|---|---|
| Mean | 56.8 ± 14.6 | 59.8 ± 14.4 | 58.3 ± 14.5 |
| Sex: Female, Male(Participants) | NIRAF Detection Technology + | NIRAF Detection Technology - | Total |
|---|---|---|---|
| Female | 62 | 63 | 125 |
| Male | 18 | 17 | 35 |
| Race/Ethnicity, Customized(Participants) | NIRAF Detection Technology + | NIRAF Detection Technology - | Total |
|---|---|---|---|
| White | 73 | 74 | 147 |
| Black | 5 | 6 | 11 |
| Asian | 1 | 0 | 1 |
| Other | 1 | 0 | 1 |
| Race/Ethnicity, Customized(Participants) | NIRAF Detection Technology + | NIRAF Detection Technology - | Total |
|---|---|---|---|
| Non-Hispanic | 79 | 80 | 159 |
| Hispanic | 1 | 0 | 1 |
| Region of Enrollment(participants) | NIRAF Detection Technology + | NIRAF Detection Technology - | Total |
|---|---|---|---|
| United States | 80 | 80 | 160 |
| Body Mass Index (BMI)(kg/m2) | NIRAF Detection Technology + | NIRAF Detection Technology - | Total |
|---|---|---|---|
| Mean | 30.77 ± 7.52 | 30.94 ± 7.72 | 30.85 ± 7.59 |
| Diagnosis(Participants) | NIRAF Detection Technology + | NIRAF Detection Technology - | Total |
|---|---|---|---|
| Primary sporadic HPT | 72 | 71 | 143 |
| Persistent HPT | 3 | 9 | 12 |
| Recurrent HPT | 1 | 0 | 1 |
| MEN1 | 2 | 0 | 2 |
| Parathyroid carcinoma | 1 | 0 | 1 |
| Lithium-induced HPT | 1 | 0 | 1 |
| Preoperative calcium (pg/dL)(mg/dL) | NIRAF Detection Technology + | NIRAF Detection Technology - | Total |
|---|---|---|---|
| Mean | 11.115 ± 0.689 | 11.112 ± 0.712 | 11.112 ± 0.712 |
3 further baseline measures are reported on the registry.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — Informed Consent Form and Clinical Study Report will be made available to other researchers as per the specified time-frame
Supporting information: Informed consent form, Clinical study report
Time frame: Clinical Study Report will be shared 6 months after publication of trial data and will be available till end date of trial. Informed Consent Form will be shared for a year after the primary completion date of the trial.
Access criteria: Request for Individual Patient Data (IPD) - Informed consent Form and Clinical Study Report - will be reviewed by the principal investigator of this clinical trial, before granting access to IPD
This study is completed, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.
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