Parathyroid DiseasesNCT05152927
Near Infrared Autofluorescence (NIRAF) Detection for Identifying Parathyroid Glands During Parathyroidectomy
A study testing Parathyroid Eye (PTeye) in people with Parathyroid Diseases and Parathyroid Dysfunction, run by University of California, San Francisco at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parathyroid Diseases, Parathyroid Dysfunction, Parathyroid Neoplasms
- What is being tested?
- Parathyroid Eye (PTeye)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 79 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Jan 2022to 30 Nov 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Children and minors
- Pregnant women
- Patients with concurrent parathyroid and thyroid disease that require total thyroidectomy
- Patients with secondary or tertiary hyperparathyroidism
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, San Francisco
San Francisco, California, 94143
About this study
Official title: Evaluating Impact of Near Infrared Autofluorescence (NIRAF) Detection for Identifying Parathyroid Glands During Parathyroidectomy
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.
Read the detailed description
This is a prospective, single-blinded, randomized study comparing the use of PTeye during parathyroidectomy to usual standard practice.
PRIMARY OBJECTIVES:
- 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.
- Conditions
- Parathyroid Diseases, Parathyroid Dysfunction, Parathyroid Neoplasms, Parathyroid Adenoma, Hypercalcemia, Neoplasms, Glandular and Epithelial
- Being tested
- Parathyroid Eye (PTeye)
- Keywords
- Near Infrared Autofluorescence, Parathyroidectomy, Intraoperative Parathyroid Identification, Persistent Hyperparathyroidism, Persistent Hypercalcemia, Failed Parathyroidectomy, Repeat Parathyroidectomy
- Medical subject headings
- Parathyroid Diseases, Parathyroid Neoplasms, Hypercalcemia, Neoplasms, Glandular and Epithelial, Endocrine Gland Neoplasms, Adenoma, Hyperparathyroidism, Hyperparathyroidism, Primary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parathyroid Eye (PTeye)Device
Also called Near Infrared Autofluorescence (NIRAF), NIRAF detection modality, PTeye
Intraoperative Tool
| Study group | Role | What they receive |
|---|---|---|
| Parathyroid Eye (PTeye) | Experimental | 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. Receives: Device: Parathyroid Eye (PTeye) |
| Usual Standard of Care | No intervention | 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Median Number of Frozen Sections (or Parathyroid Aspirate) Sent for Analysis
Median number of frozen sections (or aspirate) sent for analysis during the parathyroidectomy (PTx) procedure to confirm potential parathyroid tissue
Measured: At the end of the parathyroidectomy, up to 5 hours
Secondary outcomes (15)
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.
Measured: 5-14 days after PTx procedure
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.
Measured: 5-14 days after PTx procedure
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.
Measured: Up to 6 months after PTx procedure
Number of Parathyroid Glands (PG) Identified
Overall number of parathyroid glands identified (Combined both the experimental Group (Glands identified with naked eye + NIRAF) and Control Group (Glands identified with naked eye)
Measured: At the end of the parathyroidectomy, up to 5 hours
Median Number of Parathyroid Glands Identified With NIRAF (PTeye Group Only)
Median number of parathyroid glands identified with NIRAF, which was not seen with surgeon's naked eye during bilateral neck explorations (where the surgeon is looking for more than 1 parathyroid gland)
Measured: At the end of the parathyroidectomy, up to 5 hours
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
Measured: At the end of the parathyroidectomy, up to 5 hours
Median Number of Intra-operative Parathyroid Hormone (PTH) Assays Sent
The median number of intra-operative parathyroid hormone assays (per person) sent during the procedure to the lab
Measured: At the end of the parathyroidectomy, up to 5 hours
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
Measured: During parathyroidectomy, up to 5 hours
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
Measured: At the end of the parathyroidectomy, up to 5 hours
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
Measured: Up to 5 hours
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
Measured: At the end of the parathyroidectomy, up to 5 hours
Median Number of Nights in the Hospital After Parathyroidectomy
Median number of nights spent in the hospital post-surgery is defined as having spent <= 23 hours (0 nights) or > 23 hours (1 night) at the hospital for postoperative recovery after the surgical procedure. Participants who had surgery scheduled for later in the day will be counted as spending one night in the hospital due to the minimum required observation period post-surgery and followed institutional standards for discharge; discharged the next day. Participants who had surgery scheduled for earlier in the day were discharged on the same day of surgery.
Measured: 0-72 hours after PTx procedure
Median Number of 'False Positive' Tissue Samples Excised by Surgeon
The median number of tissues per person that were excised by surgeon assumed to be parathyroid tissue, but is later validated as non-parathyroid tissue (false positive) by histology
Measured: Up to 10 days after PTx procedure
Number of Participants With Reported Doctor Visits/Emergency Department Visits or Hospital Admissions
Number of participants who required a doctor visit/emergency department visit and/or hospital admission due to persistent hypercalcemia and/or associated symptoms after the parathyroidectomy procedure will be categorized as binary (yes or no) if any follow-up visits or admissions occurred.
Measured: Up to 6 months after PTx procedure
Number of Participants Who Have Had Repeat Parathyroidectomy (PTx) Procedure
Number of participants with an indication that repeat PTx procedure may need to be performed after the current procedure will be categorized as binary (yes or no)
Measured: From 6 - 12 months after PTx procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2021
- Study start10 Jan 2022
- Primary completion30 Nov 2024
- Study completion30 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Parathyroid DiseasesStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Quan-Yang Duh, MD, FACS, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05152927
- Sponsor's protocol ID
- 21208
- Other IDs
- 5R01CA212147-02
- Status last verified
- Nov 2025
- First submitted
- 29 Nov 2021
- Last updated
- 15 Dec 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 24238054Thomas 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.
PubMed 34024629Cousart AG, Kiernan CM, Willmon PA, Thomas G, Wang TS, Gauger PG, Duh QY, Underwood HJ, Jackson A, Patel A, Mahadevan-Jansen A, Solorzano CC. Near-Infrared Autofluorescence for Parathyroid Detection During Endocrine Neck Surgery: A Randomized Clinical Trial. JAMA Surg. 2025 Sep 1;160(9):936-944. doi: 10.1001/jamasurg.2025.2233.
PubMed 40668552
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Impact of Near Infrared Autofluorescence (NIRAF) Detection for Identifying Parathyroid Glands During Parathyroidectomy
- ClinicalTrials.gov ID
- NCT05152927
- Acronym / sponsor ID
- 21208
- Conditions
- Parathyroid Diseases, Parathyroid Dysfunction, Parathyroid Neoplasms, Parathyroid Adenoma, Hypercalcemia, Neoplasms, Glandular and Epithelial
- Keywords
- Near Infrared Autofluorescence, Parathyroidectomy, Intraoperative Parathyroid Identification, Persistent Hyperparathyroidism, Persistent Hypercalcemia, Failed Parathyroidectomy, Repeat Parathyroidectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- Vanderbilt University Medical Center, National Cancer Institute (NCI)
- Study start
- 10 Jan 2022 (actual)
- Primary completion
- 30 Nov 2024 (actual)
- Study completion
- 30 Nov 2024 (actual)
- First posted
- 10 Dec 2021 (actual)
- Results
- Posted 15 Dec 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Parathyroid Eye (PTeye) | Experimental | Device: Parathyroid Eye (PTeye)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. |
| Usual Standard of Care | No intervention | –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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (4 listed)
- Children and minors
- Pregnant women
- Patients with concurrent parathyroid and thyroid disease that require total thyroidectomy
- Patients with secondary or tertiary hyperparathyroidism
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Parathyroid Eye (PTeye)Also: Near Infrared Autofluorescence (NIRAF), NIRAF detection modality, PTeyeIntraoperative Tool | Device | Parathyroid Eye (PTeye) |
Primary outcome
Median Number of Frozen Sections (or Parathyroid Aspirate) Sent for Analysis
Time frame: At the end of the parathyroidectomy, up to 5 hours
Median number of frozen sections (or aspirate) sent for analysis during the parathyroidectomy (PTx) procedure to confirm potential parathyroid tissue
15 secondary outcomes
Number of Participants With Persistent Hyperparathyroidism (Immediate)
Time frame: 5-14 days after PTx procedure
Number of Participants With Persistent Hyperparathyroidism or Hypercalcemia (Transient)
Time frame: 5-14 days after PTx procedure
Number of Participants Persistent Hyperparathyroidism or Hypercalcemia (Failed Parathyroidectomy)
Time frame: Up to 6 months after PTx procedure
Number of Parathyroid Glands (PG) Identified
Time frame: At the end of the parathyroidectomy, up to 5 hours
Median Number of Parathyroid Glands Identified With NIRAF (PTeye Group Only)
Time frame: At the end of the parathyroidectomy, up to 5 hours
Median Number of Diseased Parathyroid Glands Identified Versus Preoperatively Localized Glands
Time frame: At the end of the parathyroidectomy, up to 5 hours
Median Number of Intra-operative Parathyroid Hormone (PTH) Assays Sent
Time frame: At the end of the parathyroidectomy, up to 5 hours
Median Duration Taken to Identify First Parathyroid Gland
Time frame: During parathyroidectomy, up to 5 hours
Median Duration Taken to Identify Last Parathyroid Gland
Time frame: At the end of the parathyroidectomy, up to 5 hours
Median Duration of Parathyroidectomy (PTx) Procedure
Time frame: Up to 5 hours
Median Duration for Intraoperative Parathyroid Hormone (PTH) to Normalize
Time frame: At the end of the parathyroidectomy, up to 5 hours
Median Number of Nights in the Hospital After Parathyroidectomy
Time frame: 0-72 hours after PTx procedure
Median Number of 'False Positive' Tissue Samples Excised by Surgeon
Time frame: Up to 10 days after PTx procedure
Number of Participants With Reported Doctor Visits/Emergency Department Visits or Hospital Admissions
Time frame: Up to 6 months after PTx procedure
Number of Participants Who Have Had Repeat Parathyroidectomy (PTx) Procedure
Time frame: From 6 - 12 months after PTx procedure
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 24238054McWade 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.
- Background: PubMed 34024629Thomas 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.
- Derived from this study: PubMed 40668552Cousart AG, Kiernan CM, Willmon PA, Thomas G, Wang TS, Gauger PG, Duh QY, Underwood HJ, Jackson A, Patel A, Mahadevan-Jansen A, Solorzano CC. Near-Infrared Autofluorescence for Parathyroid Detection During Endocrine Neck Surgery: A Randomized Clinical Trial. JAMA Surg. 2025 Sep 1;160(9):936-944. doi: 10.1001/jamasurg.2025.2233.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Quan-Yang Duh, MD, FACS principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Parathyroid Eye (PTeye) in people with Parathyroid Diseases and Parathyroid Dysfunction, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Dec 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Median Number of Frozen Sections (or Parathyroid Aspirate) Sent for Analysis (time frame: At the end of the parathyroidectomy, up to 5 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05152927, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2025.