Clinical trial NCT05022641: Evaluating Impact of Near Infrared Autofluorescence (NIRAF) Detection for Identifying Parathyroid Glands During Parathyroidectomy
Official title: Evaluating Impact of Near Infrared Autofluorescence (NIRAF) Detection for Identifying Parathyroid Glands During Parathyroidectomy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Parathyroid Adenoma
Parathyroid Neoplasms
Parathyroid Cancer
Hypercalcemia
Primary Hyperparathyroidism
Keywords: Parathyroidectomy
Intraoperative Parathyroid Identification
Near Infrared Autofluorescence
Persistent Hyperparathyroidism
Persistent Hypercalcemia
Failed Parathyroidectomy
Repeat Parathyroidectomy
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: Vanderbilt University
First posted: 2021-08-26
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Blood calcium levels
timeFrame: Before surgery (baseline)
measure: Blood calcium levels
timeFrame: 5-14 days after surgery
measure: Blood calcium levels
timeFrame: 6 months after surgery
measure: Parathyroid hormone (PTH) levels
timeFrame: Intraoperative levels (baseline, excision, 5 minutes)
measure: Parathyroid hormone (PTH) levels
timeFrame: 5-14 days after surgery
measure: Parathyroid hormone (PTH) levels
timeFrame: 6 months after surgery
Secondary outcomes:
measure: Duration of Surgery in minutes
timeFrame: Collected immediately following surgery
measure: Number of frozen section analysis performed (by case)
timeFrame: Collected immediately following surgery
measure: Percent of frozen sections confirmed as parathyroid tissue
timeFrame: Frozen results collected immediately after surgery.
measure: Permanent histology - parathyroid tissue, cellularity, gland weight
timeFrame: Permanent histology collected after report generated by pathologist (5-7 days)
measure: Number of postsurgical complications
timeFrame: up to 30 days
measure: Frequency of postoperative (within 30 days) Emergency Room visits or hospitalization
timeFrame: up to 30 days
measure: Percent of repeat surgeries due to high calcium
timeFrame: up to 6 months
measure: Average number of minutes taken to identify first parathyroid gland
timeFrame: Immediate. During PTx procedure
measure: Average number of minutes taken to identify last parathyroid gland
timeFrame: Immediate. During PTx procedure
measure: Minutes taken for intraoperative parathyroid hormone (PTH) to normalize
timeFrame: Immediate. During PTx procedure.
measure: Number of nights spent in the hospital after parathyroidectomy
timeFrame: 0-72 hours after PTx procedure.
measure: Overall number of parathyroid glands identified.
timeFrame: Time Frame: Immediate. During total thyroidectomy procedure.
measure: Number of patients who have had repeat parathyroidectomy (PTx) procedure
timeFrame: 6 months after PTx procedure
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: The University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Paul Gauger
role: PRINCIPAL_INVESTIGATOR
References: