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

Primary Hyperparathyroidism Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05022641
• Other study ID #: HUM00192089
• Secondary ID: 5R01CA212147-02
• Status: Recruiting
• Phase: N/A
• Start date: December 1, 2021
• Est. completion date: August 2024

Study information

• Verified date: September 2023
• Source: University of Michigan
• Contact: Anee Sophia Jackson
• Phone: 734-647-1511
• Email: aneesoph[@]med.umich.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study will see if 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 is better than a surgeon's detection alone. It compares risk-benefits and outcomes in PTx patients where NIRAF detection with PTeye for parathyroid identification is either used or not used.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 160
• Est. completion date: August 2024
• Est. primary completion date: August 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Primary hyperparathyroidism who will be undergoing parathyroid surgery

• Persistent primary hyperparathyroidism after having undergone a failed prior parathyroid surgery who will be undergoing repeat parathyroid surgery

Exclusion Criteria:

• Pregnant women (Those patients who could potentially will receive preoperative pregnancy testing, as is standard before general anesthesia. Any patients with positive pregnancy test results will not be included in the study.)

• Patients with concurrent parathyroid and thyroid disease that require total thyroidectomy

• Patients with secondary or tertiary hyperparathyroidism

Related Conditions & MeSH terms

• Adenoma
• Hypercalcemia
• Hyperparathyroidism
• Hyperparathyroidism, Primary
• Parathyroid Adenoma
• Parathyroid Cancer
• Parathyroid Neoplasms
• Primary Hyperparathyroidism

Intervention

Device:
• PTeye
The surgeon will first take 5 baseline NIRAF measurements on the thyroid gland (or neck muscle, if thyroid is absent) using the disposable sterile fiber probe that is connected to the PTeye console (see Figure 1), as per device functionality requirements.

Locations

Country	Name	City	State
United States	The University of Michigan	Ann Arbor	Michigan

Sponsors (3)

Lead Sponsor	Collaborator
University of Michigan	National Cancer Institute (NCI), Vanderbilt University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood calcium levels		Before surgery (baseline)
Primary	Blood calcium levels		5-14 days after surgery
Primary	Blood calcium levels		6 months after surgery
Primary	Parathyroid hormone (PTH) levels	Intraoperative levels, (e.g. baseline, excision, 5 minutes).	Intraoperative levels (baseline, excision, 5 minutes)
Primary	Parathyroid hormone (PTH) levels		5-14 days after surgery
Primary	Parathyroid hormone (PTH) levels		6 months after surgery
Secondary	Duration of Surgery in minutes		Collected immediately following surgery
Secondary	Number of frozen section analysis performed (by case)		Collected immediately following surgery
Secondary	Percent of frozen sections confirmed as parathyroid tissue		Frozen results collected immediately after surgery.
Secondary	Permanent histology - parathyroid tissue, cellularity, gland weight		Permanent histology collected after report generated by pathologist (5-7 days)
Secondary	Number of postsurgical complications	Medical record review	up to 30 days
Secondary	Frequency of postoperative (within 30 days) Emergency Room visits or hospitalization	Medical record review	up to 30 days
Secondary	Percent of repeat surgeries due to high calcium	Repeat surgeries are documented as binary (yes or no)	up to 6 months
Secondary	Average number of minutes taken to identify first parathyroid gland	Duration taken to identify 1st parathyroid gland in PTx procedure - timed from skin incision to finding parathyroid gland in each participant.	Immediate. During PTx procedure
Secondary	Average number of minutes taken to identify last parathyroid gland	Duration taken to identify last parathyroid gland in PTx procedure - timed from skin incision to finding the last parathyroid gland in each participant.	Immediate. During PTx procedure
Secondary	Minutes taken for intraoperative parathyroid hormone (PTH) to normalize	Time 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.	Immediate. During PTx procedure.
Secondary	Number of nights spent in the hospital after parathyroidectomy	Number of nights spent for postoperative recovery in the hospital after the surgical procedure.	0-72 hours after PTx procedure.
Secondary	Overall number of parathyroid glands identified.	Overall number of parathyroid glands identified (Experimental Group: Glands identified with naked eye + NIRAF; Control Group: Glands identified with naked eye)	Time Frame: Immediate. During total thyroidectomy procedure.
Secondary	Number of patients who have had repeat parathyroidectomy (PTx) procedure	Number of patients with repeat PTx procedure performed after the current procedure	6 months after PTx procedure