Assessing Benefits of Near Infrared Autofluorescence (NIRAF) Detection for Identifying Parathyroid Glands During Total Thyroidectomy

Neoplasms Clinical Trial

Official title:

Assessing Benefits of Near Infrared Autofluorescence (NIRAF) Detection for Identifying Parathyroid Glands During Total Thyroidectomy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05022667
• Other study ID #: HUM00194322
• Secondary ID: R01CA212147
• 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 a 'Parathyroid Eye (PTeye)' for identifying parathyroid glands (PGs) during total thyroidectomy (TTx) is better than surgeon's detection alone. It compares risk, benefits and outcomes in TTx 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:

• Patients with thyroid disease who will be undergoing total thyroidectomy (includes patients who have undergone a prior neck exploration for parathyroid disease or other but have an intact thyroid gland).

• Patients with persisting thyroid disease and will be undergoing re-operative or completion thyroidectomy.

Exclusion Criteria:

• Pregnant women

• Patients with concurrent parathyroid and thyroid disease

• Patients with incidental enlarged parathyroid discovered during thyroidectomy procedure.

• Patients undergoing thyroid lobectomy or partial thyroidectomy

Related Conditions & MeSH terms

• Endocrine Gland Neoplasms
• Endocrine System Diseases
• Head and Neck Neoplasms
• Hypoparathyroidism
• Neoplasms
• Neoplasms by Site
• Parathyroid Diseases
• Thyroid Diseases
• Thyroid Neoplasms

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, 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		Within 24 hours after surgery
Primary	Blood parathyroid hormone (PTH) levels		Within 24 hours after surgery
Primary	Blood parathyroid hormone (PTH) levels		5-14 days after surgery
Primary	Blood parathyroid hormone (PTH) levels		6 months after surgery
Secondary	Duration in minutes of surgery		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 reports of all excised tissues		Permanent histology collected after report generated by pathologist (5-7 days)
Secondary	History of calcium and/or Vitamin D supplementation		Within 1 month prior to surgery (including daily dose)
Secondary	History of calcium and/or Vitamin D supplementation		up to 3 months after surgery (including daily dose)
Secondary	Duration of calcium and/or Vitamin D supplementation	Duration measured in days	Within 1 month prior to surgery
Secondary	Duration of calcium and/or Vitamin D supplementation	Duration measured in days	Up to 3 months after surgery
Secondary	Number of postsurgical complications	Medical record review	Up to 3 months after surgery
Secondary	Frequency of Emergency Room (ER) visits or hospitalization due to low blood calcium within 30 days of surgery	Medical record review	up to 30 days
Secondary	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
Secondary	Number of nights spent in the hospital after total thyroidectomy	Number of nights spent for postoperative recovery in the hospital after the surgical procedure.	0 - 72 hours after total thyroidectomy
Secondary	Number of inadvertently resected parathyroid glands	Number of inadvertently resected parathyroid glands when parathyroid tissue is found in the resected thyroid specimens.	Immediate (intraoperative) to 7-10 days after total thyroidectomy (as presented in the pathology report)
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)	Immediate (During total thyroidectomy procedure)