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

• ClinicalTrials.gov Identifier: NCT04299425
• Recruitment Status: Completed
• First Posted: March 6, 2020
• Results First Posted: May 13, 2024
• Last Update Posted: May 13, 2024
• Sponsor: Vanderbilt-Ingram Cancer Center
• Collaborator: National Cancer Institute (NCI)
• Information provided by (Responsible Party): Carmen Solorzano, Vanderbilt-Ingram Cancer Center

• Study Type: Interventional
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Participant); Primary Purpose: Prevention
• Conditions: Parathyroid Adenoma; Parathyroid Neoplasms; Parathyroid Hyperplasia; Parathyroid Cancer; Hypercalcemia; Primary Hyperparathyroidism
• Intervention: Device: NIRAF Detection Technology
• Enrollment: 160

Participant Flow

Recruitment Details
Pre-assignment Details

Arm/Group Title	NIRAF Detection Technology +	NIRAF Detection Technology -
Arm/Group Description	Parathyroid gland identification will be performed with PTeye using NIRAF detection technology as an adjunctive tool in patients who undergo parathyroidectomy (PTx). 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.	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).
Period Title: Overall Study
Started	80	80
Completed	80	80
Not Completed	0	0

Baseline Characteristics

Arm/Group Title		NIRAF Detection Technology +	NIRAF Detection Technology -	Total
Arm/Group Description		Parathyroid gland identification will be performed with PTeye using NIRAF detection technology as an adjunctive tool in patients who undergo parathyroidectomy (PTx). 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.	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).	Total of all reporting groups
Overall Number of Baseline Participants		80	80	160
Baseline Analysis Population Description		[Not Specified]
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	80 participants	80 participants	160 participants
		56.8 (14.6)	59.8 (14.4)	58.3 (14.5)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	80 participants	80 participants	160 participants
	Female	62 77.5%	63 78.8%	125 78.1%
	Male	18 22.5%	17 21.3%	35 21.9%
Race/Ethnicity, Customized; Measure Type: Count of Participants; Unit of measure: Participants	Number Analyzed	80 participants	80 participants	160 participants
White		73 91.3%	74 92.5%	147 91.9%
Black		5 6.3%	6 7.5%	11 6.9%
Asian		1 1.3%	0 0.0%	1 0.6%
Other		1 1.3%	0 0.0%	1 0.6%
Race/Ethnicity, Customized; Measure Type: Count of Participants; Unit of measure: Participants	Number Analyzed	80 participants	80 participants	160 participants
Non-Hispanic		79 98.8%	80 100.0%	159 99.4%
Hispanic		1 1.3%	0 0.0%	1 0.6%
Region of Enrollment; Measure Type: Number; Unit of measure: Participants
United States	Number Analyzed	80 participants	80 participants	160 participants
		80	80	160
Body Mass Index (BMI); Mean (Standard Deviation); Unit of measure: Kg/m2
	Number Analyzed	80 participants	80 participants	160 participants
		30.77 (7.52)	30.94 (7.72)	30.85 (7.59)
Diagnosis; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	80 participants	80 participants	160 participants
	Primary sporadic HPT	72 90.0%	71 88.8%	143 89.4%
	Persistent HPT	3 3.8%	9 11.3%	12 7.5%
	Recurrent HPT	1 1.3%	0 0.0%	1 0.6%
	MEN1	2 2.5%	0 0.0%	2 1.3%
	Parathyroid carcinoma	1 1.3%	0 0.0%	1 0.6%
	Lithium-induced HPT	1 1.3%	0 0.0%	1 0.6%
Preoperative calcium (pg/dL); Mean (Standard Deviation); Unit of measure: mg/dL
	Number Analyzed	80 participants	80 participants	160 participants
		11.115 (0.689)	11.112 (0.712)	11.112 (0.712)
Preoperative PTH (pg/mL); Mean (Standard Deviation); Unit of measure: pg/mL
	Number Analyzed	80 participants	80 participants	160 participants
		152.3 (79.8)	163.6 (139)	157.9 (112.7)
Preoperative vitamin D; Mean (Standard Deviation); Unit of measure: Mcg
	Number Analyzed	80 participants	80 participants	160 participants
		36.7 (16)	39.6 (20.5)	38.1 (18.2)
Procedure by intention; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	80 participants	80 participants	160 participants
	Focused	27 33.8%	24 30.0%	51 31.9%
	Bilateral	53 66.3%	56 70.0%	109 68.1%

Outcome Measures

1. Primary Outcome

Title	Average Number of Parathyroid Glands Identified With High Confidence Per Patient
Description	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.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	NIRAF Detection Technology +	NIRAF Detection Technology -
Arm/Group Description:	Parathyroid gland identification will be performed with PTeye using NIRAF detection technology as an adjunctive tool in patients who undergo parathyroidectomy (PTx). 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.	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).
Overall Number of Participants Analyzed	80	80
Mean (Standard Deviation); Unit of Measure: parathyroid glands
	3.1 (1.21)	2.7 (1.13)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	NIRAF Detection Technology +, NIRAF Detection Technology -
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.04
	Comments	[Not Specified]
	Method	t-test, 2 sided
	Comments	[Not Specified]

2. Secondary Outcome

Title	Number of Participants With Persistent Hyperparathyroidism or Hypercalcemia (Failed Parathyroidectomy).
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	NIRAF Detection Technology +	NIRAF Detection Technology -
Arm/Group Description:	Parathyroid gland identification will be performed with PTeye using NIRAF detection technology as an adjunctive tool in patients who undergo parathyroidectomy (PTx). 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.	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).
Overall Number of Participants Analyzed	80	80
Measure Type: Count of Participants; Unit of Measure: Participants
	0 0.0%	1 1.3%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	NIRAF Detection Technology +, NIRAF Detection Technology -
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	1.0
	Comments	[Not Specified]
	Method	Chi-squared
	Comments	[Not Specified]

3. Secondary Outcome

Title	Number of Frozen Sections Sent for Analysis
Description	Number of frozen sections sent for analysis during the procedure to confirm potential parathyroid tissue
Time Frame	Immediate. During PTx procedure.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	NIRAF Detection Technology +	NIRAF Detection Technology -
Arm/Group Description:	Parathyroid gland identification will be performed with PTeye using NIRAF detection technology as an adjunctive tool in patients who undergo parathyroidectomy (PTx). 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.	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).
Overall Number of Participants Analyzed	80	80
Measure Type: Number; Unit of Measure: frozen sections
	13	45

4. Secondary Outcome

Title	Duration of Parathyroidectomy (PTx) Procedure
Description	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.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	NIRAF Detection Technology +	NIRAF Detection Technology -
Arm/Group Description:	Parathyroid gland identification will be performed with PTeye using NIRAF detection technology as an adjunctive tool in patients who undergo parathyroidectomy (PTx). 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.	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).
Overall Number of Participants Analyzed	80	80
Mean (Standard Deviation); Unit of Measure: minutes
	89.3 (32.6)	95.5 (39.7)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	NIRAF Detection Technology +, NIRAF Detection Technology -
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.55
	Comments	[Not Specified]
	Method	t-test, 2 sided
	Comments	[Not Specified]

5. Secondary Outcome

Title	Number of Participants Stratified by Duration of Hospital Stay
Description	Number of nights spent for postoperative recovery in the hospital after the surgical procedure.
Time Frame	0-72 hours after PTx procedure.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	NIRAF Detection Technology +	NIRAF Detection Technology -
Arm/Group Description:	Parathyroid gland identification will be performed with PTeye using NIRAF detection technology as an adjunctive tool in patients who undergo parathyroidectomy (PTx). 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.	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).
Overall Number of Participants Analyzed	80	80
Measure Type: Count of Participants; Unit of Measure: Participants
Discharged same day	64 80.0%	66 82.5%
Overnight	14 17.5%	14 17.5%
Admitted > 23 hours	2 2.5%	0 0.0%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	NIRAF Detection Technology +, NIRAF Detection Technology -
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.36
	Comments	[Not Specified]
	Method	Chi-squared
	Comments	[Not Specified]

6. Secondary Outcome

Title	Number of 'False Positive' Tissues Excised by Surgeon
Description	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.

Outcome Measure Data

Analysis Population Description

Only the NIRAF Detection Technology + arm was included in the analysis to calculate the rate of false positives by the device. Since the NIRAF Detection Technology - did not use the device that arm was not included.

Arm/Group Title	NIRAF Detection Technology +
Arm/Group Description:	Parathyroid gland identification will be performed with PTeye using NIRAF detection technology as an adjunctive tool in patients who undergo parathyroidectomy (PTx). 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.
Overall Number of Participants Analyzed	80
Measure Type: Number; Unit of Measure: false positives
	19

7. Secondary Outcome

Title	Number of Patients Who Have Had Repeat Parathyroidectomy (PTx) Procedure
Description	Number of patients with repeat PTx procedure performed after the current procedure.
Time Frame	At 6-months post-operation

Outcome Measure Data

Analysis Population Description

Nearly all patients attended their first follow-up appointment (5-14 days post-operation), however about 30 patients were lost for long-term follow-up.

Arm/Group Title	NIRAF Detection Technology +	NIRAF Detection Technology -
Arm/Group Description:	Parathyroid gland identification will be performed with PTeye using NIRAF detection technology as an adjunctive tool in patients who undergo parathyroidectomy (PTx). 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.	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).
Overall Number of Participants Analyzed	51	50
Measure Type: Count of Participants; Unit of Measure: Participants
	0 0.0%	1 2.0%

Adverse Events

Time Frame	Adverse event data was collected for 2 years, 5 months.
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	NIRAF Detection Technology +	NIRAF Detection Technology -
Arm/Group Description	Parathyroid gland identification will be performed with PTeye using NIRAF detection technology as an adjunctive tool in patients who undergo parathyroidectomy (PTx). 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.	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).
All-Cause Mortality
	NIRAF Detection Technology +	NIRAF Detection Technology -
	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/80 (0.00%)	0/80 (0.00%)
Serious Adverse Events
	NIRAF Detection Technology +	NIRAF Detection Technology -
	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/80 (0.00%)	0/80 (0.00%)
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	0%
	NIRAF Detection Technology +	NIRAF Detection Technology -
	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/80 (0.00%)	0/80 (0.00%)

Limitations and Caveats

Only 63% of the cohort had follow-up for 6-months or longer, which may underestimate the rate of failure. The relatively small sample size may miss rare events such as operative failure. Additionally, inter-variability amongst the two surgeons and their surgical approaches adds more complexity. Lastly, these findings may only be generalizable to higher volume centers with more experienced surgeons.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

• Name/Title: Dr. Carmen C Solorzano
• Organization: Vanderbilt University Medical Center
• Phone: 615-343-2735
• EMail: carmen.solorzano@vumc.org

Publications:

Simental A, Ferris RL. Reoperative parathyroidectomy. Otolaryngol Clin North Am. 2008 Dec;41(6):1269-74, xii. doi: 10.1016/j.otc.2008.05.008.

Cron DC, Kapeles SR, Andraska EA, Kwon ST, Kirk PS, McNeish BL, Lee CS, Hughes DT. Predictors of operative failure in parathyroidectomy for primary hyperparathyroidism. Am J Surg. 2017 Sep;214(3):509-514. doi: 10.1016/j.amjsurg.2017.01.012. Epub 2017 Jan 10.

Doherty GM, Weber B, Norton JA. Cost of unsuccessful surgery for primary hyperparathyroidism. Surgery. 1994 Dec;116(6):954-7; discussion 957-8.

Wachtel H, Cerullo I, Bartlett EK, Kelz RR, Karakousis GC, Fraker DL. What Can We Learn from Intraoperative Parathyroid Hormone Levels that Do Not Drop Appropriately? Ann Surg Oncol. 2015;22(6):1781-8. doi: 10.1245/s10434-014-4201-9. Epub 2014 Oct 30.

Mohebati A, Shaha AR. Imaging techniques in parathyroid surgery for primary hyperparathyroidism. Am J Otolaryngol. 2012 Jul-Aug;33(4):457-68. doi: 10.1016/j.amjoto.2011.10.010. Epub 2011 Dec 7.

Ahuja AT, Wong KT, Ching AS, Fung MK, Lau JY, Yuen EH, King AD. Imaging for primary hyperparathyroidism--what beginners should know. Clin Radiol. 2004 Nov;59(11):967-76. doi: 10.1016/j.crad.2004.04.005.

Sosa JA, Powe NR, Levine MA, Udelsman R, Zeiger MA. Profile of a clinical practice: Thresholds for surgery and surgical outcomes for patients with primary hyperparathyroidism: a national survey of endocrine surgeons. J Clin Endocrinol Metab. 1998 Aug;83(8):2658-65. doi: 10.1210/jcem.83.8.5006.

Chen H, Wang TS, Yen TW, Doffek K, Krzywda E, Schaefer S, Sippel RS, Wilson SD. Operative failures after parathyroidectomy for hyperparathyroidism: the influence of surgical volume. Ann Surg. 2010 Oct;252(4):691-5. doi: 10.1097/SLA.0b013e3181f698df.

Novis DA, Zarbo RJ. Interinstitutional comparison of frozen section turnaround time. A College of American Pathologists Q-Probes study of 32868 frozen sections in 700 hospitals. Arch Pathol Lab Med. 1997 Jun;121(6):559-67.

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.

McWade MA, Paras C, White LM, Phay JE, Mahadevan-Jansen A, Broome JT. A novel optical approach to intraoperative detection of parathyroid glands. Surgery. 2013 Dec;154(6):1371-7; discussion 1377. doi: 10.1016/j.surg.2013.06.046.

Voelker R. Devices Help Surgeons See Parathyroid Tissue. JAMA. 2018 Dec 4;320(21):2193. doi: 10.1001/jama.2018.18768. No abstract available.

• Responsible Party: Carmen Solorzano, Vanderbilt-Ingram Cancer Center
• ClinicalTrials.gov Identifier: NCT04299425
• Other Study ID Numbers: IRB 192486; 5R01CA212147-02 ( U.S. NIH Grant/Contract )
• First Submitted: March 4, 2020
• First Posted: March 6, 2020
• Results First Submitted: February 23, 2024
• Results First Posted: May 13, 2024
• Last Update Posted: May 13, 2024