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NCT04299425 · REGISTRY CONDITION SEARCH

Evaluating Impact of NIRAF Detection for Identifying Parathyroid Glands During Parathyroidectomy

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase
NA
Status at capture
COMPLETED
Registry last update
2024-05-13

This study describes a single center, randomized, single-blinded clinical trial to assess the clinical benefits of 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. It compares risk-benefits and outcomes in PTx patients where NIRAF detection with PTeye for parathyroid identification is either used or not used.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Average Number of Parathyroid Glands Identified With High Confidence Per Patient

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outcome · POSTED

Number of Participants With Persistent Hyperparathyroidism or Hypercalcemia (Failed Parathyroidectomy).

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outcome · POSTED

Number of Frozen Sections Sent for Analysis

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outcome · POSTED

Duration of Parathyroidectomy (PTx) Procedure

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outcome · POSTED

Number of Participants Stratified by Duration of Hospital Stay

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outcome · POSTED

Number of 'False Positive' Tissues Excised by Surgeon

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outcome · POSTED

Number of Patients Who Have Had Repeat Parathyroidectomy (PTx) Procedure

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part
eligibility Criteria
Inclusion Criteria: * All primary hyperparathyroidism patients eligible for parathyroidectomy (PTx). Both bilateral and focused mode of PTx will be considered for this study, based on the surgeon's preference. * Re-operative primary hyperparathyroidism patients who have undergone a failed prior PTx. Exclusion Criteria: * Patients with concurrent parathyroid and thyroid disease that require total thyroidectomy. * Patients with secondary or tertiary hyperparathyroidism.
healthy Volunteers
false
maximum Age
99 Years
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    Parathyroid gland identification will be performed with PTeye using NIRAF detection technology as an adjunctive tool in patients who undergo parathyroidectomy (PTx).
    intervention Names
    1. Device: NIRAF Detection Technology
    label
    NIRAF Detection Technology +
    type
    EXPERIMENTAL
  2. description
    Parathyroid gland identification will be performed with the naked eye of the surgeon without using PTeye - NIRAF detection technology in patients who undergo parathyroidectomy (PTx).
    label
    NIRAF Detection Technology -
    type
    NO_INTERVENTION
interventions
  1. arm Group Labels
    1. NIRAF Detection Technology +
    description
    Near Infrared Autofluorescence (NIRAF) detection technology or 'PTeye' consists of a disposable fiber-optic probe that emits non-ionizing radiation from a NIR 785 nm laser source, and also transmits the resulting tissue NIRAF to a photo detector. The 785 nm laser source emits a maximum power of 20 mW. The device is FDA cleared for clinical use in general surgeries and dermatological use (Class 2 device). After surgeon identifies a potential parathyroid gland in the surgical field, the surgeon places the fiber-optic probe of PTeye on suspect tissue and presses the device foot-pedal to activate tissue NIRAF measurement. Auditory beep at high frequency with a Detection Ratio \> 1.2 is interpreted by device as the suspect tissue being positive for parathyroid.
    name
    NIRAF Detection Technology
    other Names
    1. PTeye Device
    type
    DEVICE
Study design
allocation
RANDOMIZED
intervention Model
PARALLEL
intervention Model Description
NIRAF detection technology is used as an adjunctive tool for intraoperative parathyroid identification in patients who undergo parathyroidectomy (PTx) in the interventional group. Generic Name of Device: Parathyroid Autofluorescence Detection Device (NIRAF detection technology). The Parathyroid Autofluorescence Detection Device consists of a disposable fiber-optic probe that emits non-ionizing radiation from a near infrared (NIR) 785 nanometer (nm) laser source, and also transmits the resulting tissue NIRAF to a photo-detector. The 785 nm laser source emits a maximum power of 20 milliwatts (mW). The device has an FDA clearance for clinical use in general surgeries and dermatological use (Class 2 device).
masking Info
masking
SINGLE
masking Description
Only participants will be masked to the intervention.
who Masked
  1. PARTICIPANT
primary Purpose
PREVENTION
Enrollment
count
160
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    Average number of parathyroid glands identified (Experimental Group: Glands identified with naked eye + NIRAF; Control Group: Glands identified with naked eye) per patient
    measure
    Average Number of Parathyroid Glands Identified With High Confidence Per Patient
    time Frame
    Immediate. During PTx procedure.
secondary Outcomes
  1. 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.
    measure
    Number of Participants With Persistent Hyperparathyroidism or Hypercalcemia (Failed Parathyroidectomy).
    time Frame
    6 months after PTx procedure
  2. description
    Number of frozen sections sent for analysis during the procedure to confirm potential parathyroid tissue
    measure
    Number of Frozen Sections Sent for Analysis
    time Frame
    Immediate. During PTx procedure.
  3. description
    Duration of PTx procedure - timed from skin incision until the surgeon notifies the anesthesia team to awaken the patient
    measure
    Duration of Parathyroidectomy (PTx) Procedure
    time Frame
    Immediate. During PTx procedure.
  4. description
    Number of nights spent for postoperative recovery in the hospital after the surgical procedure.
    measure
    Number of Participants Stratified by Duration of Hospital Stay
    time Frame
    0-72 hours after PTx procedure.
  5. description
    Number of tissues that were excised by surgeon assumed to be parathyroid tissue, but is later validated as non-parathyroid tissue (false positive) by histology
    measure
    Number of 'False Positive' Tissues Excised by Surgeon
    time Frame
    Immediate to 10 days after PTx procedure.
  6. description
    Number of patients with repeat PTx procedure performed after the current procedure.
    measure
    Number of Patients Who Have Had Repeat Parathyroidectomy (PTx) Procedure
    time Frame
    At 6-months post-operation
Full study description
brief Summary
This study describes a single center, randomized, single-blinded clinical trial to assess the clinical benefits of 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. It compares risk-benefits and outcomes in PTx patients where NIRAF detection with PTeye for parathyroid identification is either used or not used.
detailed Description
Inability of the surgeon to identify or localize the diseased PG can occur in 5 - 10% of cases resulting in failed parathyroidectomies (PTx). As a result, persistent hyperparathyroidism can occur in these patients resulting in unnecessary repeat surgeries that may be associated with increased morbidity and costs. Ultrasound imaging, 99mTechnetium-sestamibi scintigraphy, and computed tomography (CT) have so far demonstrated variable efficacy in preoperative localization of diseased PGs and may not always correlate well with the surgical field of view as observed intraoperatively. Consequently, most surgeons rely on visual identification of PGs during surgery, whereby the accuracy of PG identification is eventually determined by her/his surgical skill and experience. When in doubt, a surgeon routinely confirms the identity of PG tissue intraoperatively by sending the specimen for frozen section analysis that typically requires a wait time of 20-30 minutes per sample and has additional costs. By easily being able to distinguish parathyroid from other tissues intraoperatively, postsurgical complications and associated costs may be reduced. The unique discovery of near infrared autofluorescence (NIRAF) in parathyroid tissues demonstrated that optical modalities that detect NIRAF can be utilized for non-invasive and label-free identification of parathyroid tissues with an accuracy as high as 97%. Since then, several research groups have explored the feasibility of localizing parathyroid glands using NIRAF detection with reasonable success, resulting in FDA clearance for marketing this optical technique. In this study, we plan to evaluate whether an FDA-cleared device called 'PTeye' (AiBiomed, Santa Barbara, CA) is beneficial or not, for the surgeon and patient during PTx operations. The results of such a study will help us to understand and assess the true impact of optical modalities such as PTeye on (i) improving the quality and efficiency of PTx surgeries and (ii) minimizing risk of postsurgical complications and related expenses. The aim of this prospective single blinded randomized study is to compare 2 groups of patients: PTx patients operated using NIRAF detection technology with PTeye as adjunct tool (NIRAF+) vs. patients operated without the adjunct technology (NIRAF-). The main objective of this study is to assess the benefit of intraoperative use of NIRAF detection technology via PTeye during PTx procedures with regard to PG identification, duration of surgery, number of frozen section analysis performed, number of intraoperative PTH assays sent and incidence of postsurgical complications, if any and history of ER visits or hospitalization or repeat surgeries due to persistent high blood calcium after PTx procedure, compared to standard of care.
Source references
references
  1. citation
    Simental A, Ferris RL. Reoperative parathyroidectomy. Otolaryngol Clin North Am. 2008 Dec;41(6):1269-74, xii. doi: 10.1016/j.otc.2008.05.008.
    pmid
    19040985
    type
    BACKGROUND
  2. citation
    Cron DC, Kapeles SR, Andraska EA, Kwon ST, Kirk PS, McNeish BL, Lee CS, Hughes DT. Predictors of operative failure in parathyroidectomy for primary hyperparathyroidism. Am J Surg. 2017 Sep;214(3):509-514. doi: 10.1016/j.amjsurg.2017.01.012. Epub 2017 Jan 10.
    pmid
    28108069
    type
    BACKGROUND
  3. citation
    Doherty GM, Weber B, Norton JA. Cost of unsuccessful surgery for primary hyperparathyroidism. Surgery. 1994 Dec;116(6):954-7; discussion 957-8.
    pmid
    7985102
    type
    BACKGROUND
  4. citation
    Wachtel H, Cerullo I, Bartlett EK, Kelz RR, Karakousis GC, Fraker DL. What Can We Learn from Intraoperative Parathyroid Hormone Levels that Do Not Drop Appropriately? Ann Surg Oncol. 2015;22(6):1781-8. doi: 10.1245/s10434-014-4201-9. Epub 2014 Oct 30.
    pmid
    25354574
    type
    BACKGROUND
  5. citation
    Mohebati A, Shaha AR. Imaging techniques in parathyroid surgery for primary hyperparathyroidism. Am J Otolaryngol. 2012 Jul-Aug;33(4):457-68. doi: 10.1016/j.amjoto.2011.10.010. Epub 2011 Dec 7.
    pmid
    22154018
    type
    BACKGROUND
  6. citation
    Ahuja AT, Wong KT, Ching AS, Fung MK, Lau JY, Yuen EH, King AD. Imaging for primary hyperparathyroidism--what beginners should know. Clin Radiol. 2004 Nov;59(11):967-76. doi: 10.1016/j.crad.2004.04.005.
    pmid
    15488844
    type
    BACKGROUND
  7. citation
    Sosa JA, Powe NR, Levine MA, Udelsman R, Zeiger MA. Profile of a clinical practice: Thresholds for surgery and surgical outcomes for patients with primary hyperparathyroidism: a national survey of endocrine surgeons. J Clin Endocrinol Metab. 1998 Aug;83(8):2658-65. doi: 10.1210/jcem.83.8.5006.
    pmid
    9709928
    type
    BACKGROUND
  8. citation
    Chen H, Wang TS, Yen TW, Doffek K, Krzywda E, Schaefer S, Sippel RS, Wilson SD. Operative failures after parathyroidectomy for hyperparathyroidism: the influence of surgical volume. Ann Surg. 2010 Oct;252(4):691-5. doi: 10.1097/SLA.0b013e3181f698df.
    pmid
    20881776
    type
    BACKGROUND
  9. citation
    Novis DA, Zarbo RJ. Interinstitutional comparison of frozen section turnaround time. A College of American Pathologists Q-Probes study of 32868 frozen sections in 700 hospitals. Arch Pathol Lab Med. 1997 Jun;121(6):559-67.
    pmid
    9199619
    type
    BACKGROUND
  10. citation
    McWade MA, Sanders ME, Broome JT, Solorzano CC, Mahadevan-Jansen A. Establishing the clinical utility of autofluorescence spectroscopy for parathyroid detection. Surgery. 2016 Jan;159(1):193-202. doi: 10.1016/j.surg.2015.06.047. Epub 2015 Oct 9.
    pmid
    26454675
    type
    BACKGROUND
  11. 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.
    pmid
    24238054
    type
    BACKGROUND
  12. citation
    Voelker R. Devices Help Surgeons See Parathyroid Tissue. JAMA. 2018 Dec 4;320(21):2193. doi: 10.1001/jama.2018.18768. No abstract available.
    pmid
    30512085
    type
    BACKGROUND
Source notices and limitations
    Discovery and provenance
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    Preserved source evidence · Not medical advice