Evaluating Impact of Near Infrared Autofluorescence (NIRAF) Detection for Identifying Parathyroid Glands During Parathyroidectomy
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: PTeye The surgeon will use the PTeye as an intraoperative tool to identify if a suspect tissue is a parathyroid or not, during the parathyroid surgery. |
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.
|
| No Intervention: Standard of Care The surgeon will rely solely on her/his surgical experience in identifying the parathyroid glands during the operations. |
Outcome Measures
Primary Outcome Measures
- Blood calcium levels [Before surgery (baseline)]
- Blood calcium levels [5-14 days after surgery]
- Blood calcium levels [6 months after surgery]
- Parathyroid hormone (PTH) levels [Intraoperative levels (baseline, excision, 5 minutes)]
Intraoperative levels, (e.g. baseline, excision, 5 minutes).
- Parathyroid hormone (PTH) levels [5-14 days after surgery]
- Parathyroid hormone (PTH) levels [6 months after surgery]
Secondary Outcome Measures
- Duration of Surgery in minutes [Collected immediately following surgery]
- Number of frozen section analysis performed (by case) [Collected immediately following surgery]
- Percent of frozen sections confirmed as parathyroid tissue [Frozen results collected immediately after surgery.]
- Permanent histology - parathyroid tissue, cellularity, gland weight [Permanent histology collected after report generated by pathologist (5-7 days)]
- Number of postsurgical complications [up to 30 days]
Medical record review
- Frequency of postoperative (within 30 days) Emergency Room visits or hospitalization [up to 30 days]
Medical record review
- Percent of repeat surgeries due to high calcium [up to 6 months]
Repeat surgeries are documented as binary (yes or no)
- Average number of minutes taken to identify first parathyroid gland [Immediate. During PTx procedure]
Duration taken to identify 1st parathyroid gland in PTx procedure - timed from skin incision to finding parathyroid gland in each participant.
- Average number of minutes taken to identify last parathyroid gland [Immediate. During PTx procedure]
Duration taken to identify last parathyroid gland in PTx procedure - timed from skin incision to finding the last parathyroid gland in each participant.
- Minutes taken for intraoperative parathyroid hormone (PTH) to normalize [Immediate. During PTx procedure.]
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.
- Number of nights spent in the hospital after parathyroidectomy [0-72 hours after PTx procedure.]
Number of nights spent for postoperative recovery in the hospital after the surgical procedure.
- Overall number of parathyroid glands identified. [Time Frame: Immediate. During total thyroidectomy procedure.]
Overall number of parathyroid glands identified (Experimental Group: Glands identified with naked eye + NIRAF; Control Group: Glands identified with naked eye)
- Number of patients who have had repeat parathyroidectomy (PTx) procedure [6 months after PTx procedure]
Number of patients with repeat PTx procedure performed after the current procedure
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | The University of Michigan | Ann Arbor | Michigan | United States | 48109 |
Sponsors and Collaborators
- University of Michigan
- National Cancer Institute (NCI)
- Vanderbilt University
Investigators
- Principal Investigator: Paul Gauger, University of Michigan
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- HUM00192089
- 5R01CA212147-02