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| ID | Type | Description | Link |
|---|---|---|---|
| 5R01CA212147-02 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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 total thyroidectomy (TTx). It compares risk-benefits and outcomes in TTx patients where NIRAF detection with PTeye for parathyroid identification is either used or not used.
Inadvertent damage or excision of a healthy parathyroid gland (PG) following a total thyroidectomy (TTx) could result in transient hypocalcemia (< 6 months) in 5 - 35% of cases or permanent hypocalcemia (> 6 months) in 7% of the patients (1, 2). In both of these circumstances, patients would require calcium and active vitamin D supplementation in addition to a potentially prolonged hospital stay and/or unplanned hospital readmission adding to unnecessary burden and healthcare costs. These complications could be minimized with label-free intraoperative PG identification using near infrared autofluorescence (NIRAF) detection with a fiber-probe based approach (3 - 5) as utilized in 'PTeye', which is medical device that was recently FDA-cleared (6). However, the true impact of this particular NIRAF-based approach on patient outcomes is yet to be determined
The aim of this prospective single blinded randomized study is to compare 2 groups of patients: TTx 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 TTx procedures with regard to postoperative hypocalcemia, PG identification, PG auto-transplantation and inadvertent resection rates compared to standard of care.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NIRAF Detection Technology + | Experimental | Parathyroid gland identification will be performed with PTeye using NIRAF detection technology as an adjunctive tool in patients who undergo total thyroidectomy (TTx) with or without lymph node dissection (LND). |
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| NIRAF Detection Technology - | No Intervention | Parathyroid gland identification will be performed with the naked eye of the surgeon without using PTeye - NIRAF detection technology in patients who undergo total thyroidectomy (TTx) with or without lymph node dissection (LND). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NIRAF Detection Technology | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Immediate. During total thyroidectomy procedure. |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative Hypoparathyroidism/Hypocalcemia (Permanent) | If blood calcium has not normalized at 1st postsurgical clinical visit, total calcium level and/or PTH is subsequently measured as necessary. Patient is defined to have permanent hypoparathyroidism if PTH < 16 pg/mL and/or activated Vitamin D is required to be symptom free at or after the 6th postoperative month. | 6 months after total thyroidectomy |
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Inclusion Criteria:
(i) All patients eligible for total thyroidectomy (TTx), with or without lymph node dissection. (includes patients undergoing a TTx who have undergone a prior neck exploration for parathyroid disease or other but have an intact thyroid).
(ii) All patients undergoing completion thyroidectomy.
Exclusion Criteria:
(i) Patients with concurrent parathyroid disease. (ii) Patients with incidental enlarged parathyroid discovered during TTx. (iii) Patients undergoing thyroid lobectomy/partial thyroidectomy.
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| Name | Affiliation | Role |
|---|---|---|
| Carmen C Solorzano, MD, FACS | Vanderbilt University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vanderbilt University Medical Center | Nashville | Tennessee | 37212 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25203484 | Background | Antakia R, Edafe O, Uttley L, Balasubramanian SP. Effectiveness of preventative and other surgical measures on hypocalcemia following bilateral thyroid surgery: a systematic review and meta-analysis. Thyroid. 2015 Jan;25(1):95-106. doi: 10.1089/thy.2014.0101. | |
| 24402815 | Background | Edafe O, Antakia R, Laskar N, Uttley L, Balasubramanian SP. Systematic review and meta-analysis of predictors of post-thyroidectomy hypocalcaemia. Br J Surg. 2014 Mar;101(4):307-20. doi: 10.1002/bjs.9384. Epub 2014 Jan 9. |
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Informed Consent Form and Clinical Study Report will be made available to other researchers as per the specified 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.
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
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| ID | Title | Description |
|---|---|---|
| FG000 | NIRAF Detection Technology + | Parathyroid gland identification will be performed with PTeye using NIRAF detection technology as an adjunctive tool in patients who undergo total thyroidectomy (TTx) with or without lymph node dissection (LND). NIRAF Detection Technology: 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. |
| FG001 | 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 total thyroidectomy (TTx) with or without lymph node dissection (LND). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | NIRAF Detection Technology + | Parathyroid gland identification will be performed with PTeye using NIRAF detection technology as an adjunctive tool in patients who undergo total thyroidectomy (TTx) with or without lymph node dissection (LND). NIRAF Detection Technology: 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | Posted | Mean | Standard Deviation | parathyroid glands | Immediate. During total thyroidectomy procedure. |
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Adverse event data was collected for 2 years and 5 months.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | NIRAF Detection Technology + | Parathyroid gland identification will be performed with PTeye using NIRAF detection technology as an adjunctive tool in patients who undergo total thyroidectomy (TTx) with or without lymph node dissection (LND). NIRAF Detection Technology: 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. |
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The median follow-up time of participants was 5-14 days post-operation. Therefore, we lack long-term follow-up (> 6 months) for the majority of the participants.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Carmen C Solorzano | Vanderbilt University Medical Center | 615-343-2735 | carmen.solorzano@vumc.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 26, 2022 | Jul 31, 2024 | Prot_SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | Dec 30, 2020 | Jan 14, 2021 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D013964 | Thyroid Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006258 | Head and Neck Neoplasms |
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NIRAF detection technology is used as an adjunctive tool for intraoperative parathyroid identification in patients who undergo total thyroidectomy (TTx) with or without lymph node dissection (LND) in the interventional group.
Generic Name of Device: Parathyroid Autofluorescence Detection Device (NIRAF detection technology).
The Parathyroid Autofluorescence Detection Device consists of a disposable fiber-optic probe that emits non-ionizing radiation from a NIR 785 nanometer (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 Milliwatts (mW). The device has an FDA clearance for clinical use in general surgeries and dermatological use (Class 2 device).
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Only participants will be masked to the intervention.
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| Postoperative Hypoparathyroidism/Hypocalcemia (Transient) | Undetectable postoperative PTH and/or low calcium (total calcium < 2mmol/L or 8 mg/dL, serum intact PTH < 16 pg/mL or 1 pmol/L) at first postoperative visit (usually 5-30 days after total thyroidectomy). | 5 days to 6 months after total thyroidectomy. |
| Postoperative Hypoparathyroidism/Hypocalcemia (Immediate) | Postoperative low calcium (total calcium <8mg/dL or <2mmol/L) and/or undetectable parathyroid hormone (PTH) (serum intact PTH < 16 pg/mL or 1 pmol/L) within 24 hours after surgery | Within 24 hours after total thyroidectomy. |
| Number of Frozen Sections Sent for Analysis (of Suspected Parathyroid Tissue). | Number of frozen sections sent for analysis during the procedure to confirm potential parathyroid tissue | Immediate. During total thyroidectomy procedure. |
| Number of Auto-transplanted Parathyroid Glands | Number of auto-transplanted parathyroid glands if the parathyroid gland was accidentally excised/devascularized. | Immediate. During total thyroidectomy procedure. |
| Number of Nights Spent in the Hospital After Total Thyroidectomy | Number of nights spent in the hospital after the surgical procedure. 0 nights, 1 night, >1 night | 0 - 4 nights after total thyroidectomy |
| Number of Inadvertently Resected Parathyroid Glands | Number of inadvertently resected parathyroid glands when parathyroid tissue is found in the resected thyroid specimens. | Intraoperatively or on histology (within 24 hours post operation) |
| 26454675 | Background | McWade MA, Sanders ME, Broome JT, Solorzano CC, Mahadevan-Jansen A. Establishing the clinical utility of autofluorescence spectroscopy for parathyroid detection. Surgery. 2016 Jan;159(1):193-202. doi: 10.1016/j.surg.2015.06.047. Epub 2015 Oct 9. |
| 30084742 | Background | Thomas G, McWade MA, Paras C, Mannoh EA, Sanders ME, White LM, Broome JT, Phay JE, Baregamian N, Solorzano CC, Mahadevan-Jansen A. Developing a Clinical Prototype to Guide Surgeons for Intraoperative Label-Free Identification of Parathyroid Glands in Real Time. Thyroid. 2018 Nov;28(11):1517-1531. doi: 10.1089/thy.2017.0716. Epub 2018 Sep 11. |
| 30442424 | Background | Thomas G, McWade MA, Nguyen JQ, Sanders ME, Broome JT, Baregamian N, Solorzano CC, Mahadevan-Jansen A. Innovative surgical guidance for label-free real-time parathyroid identification. Surgery. 2019 Jan;165(1):114-123. doi: 10.1016/j.surg.2018.04.079. Epub 2018 Nov 12. |
| 30512085 | Background | Voelker R. Devices Help Surgeons See Parathyroid Tissue. JAMA. 2018 Dec 4;320(21):2193. doi: 10.1001/jama.2018.18768. No abstract available. |
| 40668552 | Derived | Cousart AG, Kiernan CM, Willmon PA, Thomas G, Wang TS, Gauger PG, Duh QY, Underwood HJ, Jackson A, Patel A, Mahadevan-Jansen A, Solorzano CC. Near-Infrared Autofluorescence for Parathyroid Detection During Endocrine Neck Surgery: A Randomized Clinical Trial. JAMA Surg. 2025 Sep 1;160(9):936-944. doi: 10.1001/jamasurg.2025.2233. |
| BG001 | 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 total thyroidectomy (TTx) with or without lymph node dissection (LND). |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Body Mass Index (BMI) | Mean | Standard Deviation | kg/m2 |
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| Diagnosis | Count of Participants | Participants |
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| Preoperative calcium (pg/dL) | Mean | Standard Deviation | pg/dL |
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| Preoperative PTH (pg/mL) | Mean | Standard Deviation | pg/mL |
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| Preoperative vitamin D (mcg) | Mean | Standard Deviation | mcg |
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| Procedure | Count of Participants | Participants |
|
| OG001 | 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 total thyroidectomy (TTx) with or without lymph node dissection (LND). |
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| Secondary | Postoperative Hypoparathyroidism/Hypocalcemia (Permanent) | If blood calcium has not normalized at 1st postsurgical clinical visit, total calcium level and/or PTH is subsequently measured as necessary. Patient is defined to have permanent hypoparathyroidism if PTH < 16 pg/mL and/or activated Vitamin D is required to be symptom free at or after the 6th postoperative month. | Only participants with at least 6-months of follow-up were included in this analysis. The majority of follow-ups for thyroid surgery occured nat 5-14 days post-operation and most people do not return for longer follow-up unless they have on-going abnormal labs after that mark. | Posted | Count of Participants | Participants | 6 months after total thyroidectomy |
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| Secondary | Postoperative Hypoparathyroidism/Hypocalcemia (Transient) | Undetectable postoperative PTH and/or low calcium (total calcium < 2mmol/L or 8 mg/dL, serum intact PTH < 16 pg/mL or 1 pmol/L) at first postoperative visit (usually 5-30 days after total thyroidectomy). | Not all of the patients come back for follow-up. | Posted | Count of Participants | Participants | 5 days to 6 months after total thyroidectomy. |
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| Secondary | Postoperative Hypoparathyroidism/Hypocalcemia (Immediate) | Postoperative low calcium (total calcium <8mg/dL or <2mmol/L) and/or undetectable parathyroid hormone (PTH) (serum intact PTH < 16 pg/mL or 1 pmol/L) within 24 hours after surgery | 1 participant did not have their labs completed until 5-14 days post-operation. | Posted | Count of Participants | Participants | Within 24 hours after total thyroidectomy. |
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| Secondary | Number of Frozen Sections Sent for Analysis (of Suspected Parathyroid Tissue). | Number of frozen sections sent for analysis during the procedure to confirm potential parathyroid tissue | Posted | Mean | Standard Deviation | frozen sections | Immediate. During total thyroidectomy procedure. |
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| Secondary | Number of Auto-transplanted Parathyroid Glands | Number of auto-transplanted parathyroid glands if the parathyroid gland was accidentally excised/devascularized. | Posted | Number | parathyroid glands | Immediate. During total thyroidectomy procedure. |
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| Secondary | Number of Nights Spent in the Hospital After Total Thyroidectomy | Number of nights spent in the hospital after the surgical procedure. 0 nights, 1 night, >1 night | Posted | Count of Participants | Participants | 0 - 4 nights after total thyroidectomy |
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| Secondary | Number of Inadvertently Resected Parathyroid Glands | Number of inadvertently resected parathyroid glands when parathyroid tissue is found in the resected thyroid specimens. | Posted | Mean | Standard Deviation | parathyroid glands | Intraoperatively or on histology (within 24 hours post operation) |
|
|
|
| 0 |
| 80 |
| 0 |
| 80 |
| 0 |
| 80 |
| EG001 | 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 total thyroidectomy (TTx) with or without lymph node dissection (LND). | 0 | 80 | 0 | 80 | 0 | 80 |
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| D004700 |
| Endocrine System Diseases |
| D013959 | Thyroid Diseases |
| > 1 Night |
|