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

Primary Purpose

Parathyroid Diseases, Parathyroid Dysfunction, Parathyroid Neoplasms

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Parathyroid Eye (PTeye)
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Parathyroid Diseases focused on measuring Near Infrared Autofluorescence, Parathyroidectomy, Intraoperative Parathyroid Identification, Persistent Hyperparathyroidism, Persistent Hypercalcemia, Failed Parathyroidectomy, Repeat Parathyroidectomy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • All adults >=18 years old) patients with primary hyperparathyroidism who will be undergoing parathyroid surgery
  • All adult (>=18 years old) patients with persistent primary hyperparathyroidism after having undergone a failed prior parathyroid surgery who will be undergoing repeat parathyroid surgery

Exclusion Criteria:

  • Children and minors
  • Pregnant women
  • Patients with concurrent parathyroid and thyroid disease that require total thyroidectomy
  • Patients with secondary or tertiary hyperparathyroidism

Sites / Locations

  • University of California, San FranciscoRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Parathyroid Eye (PTeye)

Usual Standard of Care

Arm Description

For patients assigned to the study arm, 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.

The surgeon will proceed with the parathyroid surgery as usual, while relying solely on her/his surgical experience in identifying the parathyroid glands during the operations.

Outcomes

Primary Outcome Measures

Median number of frozen sections (or PTH aspirate) sent for analysis
Number of frozen sections (or PTH aspirate) sent for analysis during the Parathyroidectomy (PTx) procedure to confirm potential parathyroid tissue

Secondary Outcome Measures

Number of participants with persistent hyperparathyroidism (Immediate)
Failure of intra-operative parathyroid hormone (PTH) to normalize (defined as failure of PTH to drop > 50% of its baseline value at final intra-operative PTH assay and/or failure of PTH to drop < 65 pg/ml or 6.9 pmol/L). Participants will be categorized as having persistent hyperparathyroidism (Immediate) Yes or No.
Number of participants with persistent hyperparathyroidism or hypercalcemia (transient)
Elevated blood calcium levels (total blood calcium level > 10.5 mg/dL or 2.6 mmol/L) with/without elevated parathyroid hormone (PTH) (serum intact PTH > 65 pg/ml or 6.9 pmol/L) at first postoperative visit. Participants will be categorized as having persistent hyperparathyroidism or hypercalcemia (transient) Yes or No.
Number of participants persistent hyperparathyroidism or hypercalcemia (failed parathyroidectomy)
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. Participants will be categorized has having persistent hyperparathyroidism or hypercalcemia (failed parathyroidectomy), Yes or No.
Number of parathyroid glands (PG) identified
Overall number of parathyroid glands identified (Experimental Group: Glands identified with naked eye + NIRAF;Control Group: Glands identified with naked eye)
Median number of parathyroid glands identified with NIRAF
Median number of parathyroid glands identified with NIRAF, which was not seen with surgeon's naked eye
Median number of diseased parathyroid glands identified versus preoperatively localized glands
Median number of diseased parathyroid glands identified intra-operatively versus glands localized preoperatively using sestamibi, Computerized tomography (CT) or ultrasound
Median number of intra-operative parathyroid hormone (PTH) assays sent
Median number of intra-operative parathyroid hormone assays per person sent during the procedure to the lab
Median duration taken to identify first parathyroid gland
Median duration in minutes taken to identify 1st parathyroid gland in PTx procedure - timed from skin incision to finding PG
Median duration taken to identify last parathyroid gland
Median duration taken to identify last parathyroid gland in PTx procedure - timed from skin incision to finding the last PG
Median duration of parathyroidectomy (PTx) procedure
Median duration of PTx procedure - timed from skin incision until the surgeon notifies the anesthesia team to awaken the patient in minutes
Median duration for intraoperative parathyroid hormone (PTH) to normalize
Median time in minutes 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
Median number of nights spent in the hospital after parathyroidectomy
Number of nights spent for postoperative recovery in the hospital after the surgical procedure
Median number of 'false positive' tissues excised by surgeon
Median number of tissues per person that were excised by surgeon assumed to be parathyroid tissue, but is later validated as nonparathyroid tissue (false positive) by histology
Number of participants with reported doctor visits/emergency department visits or hospital admissions
Number of doctor visits/emergency department visits or hospital admissions due to persistent hypercalcemia and/or associated symptoms after parathyroidectomy procedure will be categorized as binary (yes or no)
Number of participants who have had repeat parathyroidectomy (PTx) procedure
Number of patients with repeat PTx procedure performed after the current procedure will be categorized as binary (yes or no)

Full Information

First Posted
November 29, 2021
Last Updated
August 15, 2023
Sponsor
University of California, San Francisco
Collaborators
Vanderbilt University Medical Center, National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT05152927
Brief Title
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

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 10, 2022 (Actual)
Primary Completion Date
January 31, 2025 (Anticipated)
Study Completion Date
January 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco
Collaborators
Vanderbilt University Medical Center, National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
The goal of this study is to assess whether using PTeye (AiBiomed, Santa Barbara, CA) - a NIRAF detection modality - can improve patient outcomes and reduce healthcare associated costs after parathyroid surgeries. By being able to quickly and definitively locate parathyroid glands while in the operating room, the duration of surgical procedure could be further reduced. In addition, the number of frozen section biopsy and associated costs can be minimized. Furthermore, repeat surgeries as a result of missing a diseased parathyroid gland at the time of the initial parathyroidectomy for hyperparathyroidism could potentially be avoided.
Detailed Description
This is a prospective, single-blinded, randomized study comparing the use of PTeye during parathyroidectomy to usual standard practice. PRIMARY OBJECTIVES: I. Assess the impact of PTeye on intra-operative identification of parathyroid tissues. II. Assess the impact of PTeye on improving efficiency of parathyroid surgeries. III. Assess the impact of PTeye on minimizing risk of post-surgical complications. Participants will be randomized to either the experimental or control arm. The surgeon will first take 5 baseline NIRAF measurements on the thyroid gland (or neck muscles, if thyroid is absent) using the disposable sterile fiber probe that is connected to the PTeye console, as per device functionality requirements. The subsequent step would involve touching the target tissue in the neck with the fiber optic probe, following which the PTeye will indicate to the surgeon if the tissue is likely parathyroid or not. For patients assigned to the control arm, the surgeon will not use the PTeye and will proceed with the parathyroid surgery as usual, while relying solely on her/his surgical experience in identifying the parathyroid glands during the operations. Participants will be follow-ed up for up to 6 months after surgery.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parathyroid Diseases, Parathyroid Dysfunction, Parathyroid Neoplasms, Parathyroid Adenoma, Hypercalcemia, Neoplasms, Glandular and Epithelial, Endocrine Gland Neoplasms, Adenoma, Hyperparathyroidism, Hyperparathyroidism, Primary
Keywords
Near Infrared Autofluorescence, Parathyroidectomy, Intraoperative Parathyroid Identification, Persistent Hyperparathyroidism, Persistent Hypercalcemia, Failed Parathyroidectomy, Repeat Parathyroidectomy

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Masking Description
Only participants will be masked to the intervention
Allocation
Randomized
Enrollment
110 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Parathyroid Eye (PTeye)
Arm Type
Experimental
Arm Description
For patients assigned to the study arm, 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.
Arm Title
Usual Standard of Care
Arm Type
No Intervention
Arm Description
The surgeon will proceed with the parathyroid surgery as usual, while relying solely on her/his surgical experience in identifying the parathyroid glands during the operations.
Intervention Type
Device
Intervention Name(s)
Parathyroid Eye (PTeye)
Other Intervention Name(s)
Near Infrared Autofluorescence (NIRAF), NIRAF detection modality, PTeye
Intervention Description
Intraoperative Tool
Primary Outcome Measure Information:
Title
Median number of frozen sections (or PTH aspirate) sent for analysis
Description
Number of frozen sections (or PTH aspirate) sent for analysis during the Parathyroidectomy (PTx) procedure to confirm potential parathyroid tissue
Time Frame
1 day
Secondary Outcome Measure Information:
Title
Number of participants with persistent hyperparathyroidism (Immediate)
Description
Failure of intra-operative parathyroid hormone (PTH) to normalize (defined as failure of PTH to drop > 50% of its baseline value at final intra-operative PTH assay and/or failure of PTH to drop < 65 pg/ml or 6.9 pmol/L). Participants will be categorized as having persistent hyperparathyroidism (Immediate) Yes or No.
Time Frame
1 day
Title
Number of participants with persistent hyperparathyroidism or hypercalcemia (transient)
Description
Elevated blood calcium levels (total blood calcium level > 10.5 mg/dL or 2.6 mmol/L) with/without elevated parathyroid hormone (PTH) (serum intact PTH > 65 pg/ml or 6.9 pmol/L) at first postoperative visit. Participants will be categorized as having persistent hyperparathyroidism or hypercalcemia (transient) Yes or No.
Time Frame
5-14 days after PTx procedure
Title
Number of participants 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. Participants will be categorized has having persistent hyperparathyroidism or hypercalcemia (failed parathyroidectomy), Yes or No.
Time Frame
Up to 6 months after PTx procedure
Title
Number of parathyroid glands (PG) identified
Description
Overall number of parathyroid glands identified (Experimental Group: Glands identified with naked eye + NIRAF;Control Group: Glands identified with naked eye)
Time Frame
1 day
Title
Median number of parathyroid glands identified with NIRAF
Description
Median number of parathyroid glands identified with NIRAF, which was not seen with surgeon's naked eye
Time Frame
1 day
Title
Median number of diseased parathyroid glands identified versus preoperatively localized glands
Description
Median number of diseased parathyroid glands identified intra-operatively versus glands localized preoperatively using sestamibi, Computerized tomography (CT) or ultrasound
Time Frame
1 day
Title
Median number of intra-operative parathyroid hormone (PTH) assays sent
Description
Median number of intra-operative parathyroid hormone assays per person sent during the procedure to the lab
Time Frame
1 day
Title
Median duration taken to identify first parathyroid gland
Description
Median duration in minutes taken to identify 1st parathyroid gland in PTx procedure - timed from skin incision to finding PG
Time Frame
1 day
Title
Median duration taken to identify last parathyroid gland
Description
Median duration taken to identify last parathyroid gland in PTx procedure - timed from skin incision to finding the last PG
Time Frame
1 day
Title
Median duration of parathyroidectomy (PTx) procedure
Description
Median duration of PTx procedure - timed from skin incision until the surgeon notifies the anesthesia team to awaken the patient in minutes
Time Frame
1 day
Title
Median duration for intraoperative parathyroid hormone (PTH) to normalize
Description
Median time in minutes 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
Time Frame
1 day
Title
Median number of nights spent in the hospital after parathyroidectomy
Description
Number of nights spent for postoperative recovery in the hospital after the surgical procedure
Time Frame
0-72 hours after PTx procedure
Title
Median number of 'false positive' tissues excised by surgeon
Description
Median number of tissues per person that were excised by surgeon assumed to be parathyroid tissue, but is later validated as nonparathyroid tissue (false positive) by histology
Time Frame
Up to 10 days after PTx procedure
Title
Number of participants with reported doctor visits/emergency department visits or hospital admissions
Description
Number of doctor visits/emergency department visits or hospital admissions due to persistent hypercalcemia and/or associated symptoms after parathyroidectomy procedure will be categorized as binary (yes or no)
Time Frame
Up to 6 months after PTx procedure
Title
Number of participants who have had repeat parathyroidectomy (PTx) procedure
Description
Number of patients with repeat PTx procedure performed after the current procedure will be categorized as binary (yes or no)
Time Frame
From 6 - 12 months after PTx procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: All adults >=18 years old) patients with primary hyperparathyroidism who will be undergoing parathyroid surgery All adult (>=18 years old) patients with persistent primary hyperparathyroidism after having undergone a failed prior parathyroid surgery who will be undergoing repeat parathyroid surgery Exclusion Criteria: Children and minors Pregnant women Patients with concurrent parathyroid and thyroid disease that require total thyroidectomy Patients with secondary or tertiary hyperparathyroidism
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Brandon Yap
Phone
877-827-3222
Email
Brandon.Yap@ucsf.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Quan-Yang Duh, MD, FACS
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Brandon Yap
Email
Brandon.Yap@ucsf.edu
First Name & Middle Initial & Last Name & Degree
Quan-Yang Duh, MD, FACS

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
24238054
Citation
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.
Results Reference
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PubMed Identifier
34024629
Citation
Thomas G, Solorzano CC, Baregamian N, Mannoh EA, Gautam R, Irlmeier RT, Ye F, Nelson JA, Long SE, Gauger PG, Magner A, Metcalf T, Shirley LA, Phay JE, Mahadevan-Jansen A. Comparing intraoperative parathyroid identification based on surgeon experience versus near infrared autofluorescence detection - A surgeon-blinded multi-centric study. Am J Surg. 2021 Nov;222(5):944-951. doi: 10.1016/j.amjsurg.2021.05.001. Epub 2021 May 13.
Results Reference
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Near Infrared Autofluorescence (NIRAF) Detection for Identifying Parathyroid Glands During Parathyroidectomy

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