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Evaluating Impact of NIRAF Detection for Identifying Parathyroid Glands During Parathyroidectomy (NIRAF)

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ClinicalTrials.gov Identifier: NCT04299425
Recruitment Status : Recruiting
First Posted : March 6, 2020
Last Update Posted : October 30, 2020
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Carmen Solorzano, Vanderbilt-Ingram Cancer Center

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.

Condition or disease Intervention/treatment Phase
Parathyroid Adenoma Parathyroid Neoplasms Parathyroid Hyperplasia Parathyroid Cancer Hypercalcemia Primary Hyperparathyroidism Device: NIRAF Detection Technology Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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: Single (Participant)
Masking Description: Only participants will be masked to the intervention.
Primary Purpose: Prevention
Official Title: Evaluating Impact of Near Infrared Autofluorescence (NIRAF) Detection for Identifying Parathyroid Glands During Parathyroidectomy
Actual Study Start Date : March 13, 2020
Estimated Primary Completion Date : March 2022
Estimated Study Completion Date : February 2023


Arm Intervention/treatment
Experimental: NIRAF Detection Technology +
Parathyroid gland identification will be performed with PTeye using NIRAF detection technology as an adjunctive tool in patients who undergo parathyroidectomy (PTx).
Device: NIRAF Detection Technology

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.

Other Name: PTeye Device

No Intervention: NIRAF Detection Technology -
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).



Primary Outcome Measures :
  1. Persistent hyperparathyroidism (Immediate) [ Time Frame: During parathyroidectomy (PTx) procedure ]
    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).

  2. Persistent hyperparathyroidism or hypercalcemia (transient) [ Time Frame: 5-14 days after PTx procedure ]
    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.

  3. Persistent hyperparathyroidism or hypercalcemia (failed parathyroidectomy) [ Time Frame: 6 months after PTx procedure ]
    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.


Secondary Outcome Measures :
  1. Overall number of parathyroid glands identified [ Time Frame: Immediate. During PTx procedure. ]
    Overall number of parathyroid glands identified (Experimental Group: Glands identified with naked eye + NIRAF; Control Group: Glands identified with naked eye)

  2. Number of parathyroid glands identified with NIRAF [ Time Frame: Immediate. During PTx procedure. ]
    Number of parathyroid glands identified with NIRAF, which was not seen with surgeon's naked eye

  3. Number of frozen sections sent for analysis [ Time Frame: Immediate. During PTx procedure. ]
    Number of frozen sections sent for analysis during the procedure to confirm potential parathyroid tissue

  4. Number of diseased parathyroid glands identified versus preoperatively localized glands [ Time Frame: Preoperative to immediate during PTx procedure. ]
    Number of diseased parathyroid glands identified intra-operatively versus glands localized preoperatively using sestamibi, CT or ultrasound

  5. Number of intra-operative parathyroid hormone (PTH) assays sent [ Time Frame: Immediate. During PTx procedure. ]
    Number of intra-operative parathyroid hormone assays sent during the procedure

  6. Duration taken to identify first parathyroid gland [ Time Frame: Immediate. During PTx procedure. ]
    Duration taken to identify 1st parathyroid gland in PTx procedure - timed from skin incision to finding PG.

  7. Duration taken to identify last parathyroid gland [ Time Frame: Immediate. During PTx procedure. ]
    Duration taken to identify last parathyroid gland in PTx procedure - timed from skin incision to finding the last PG.

  8. Duration of parathyroidectomy (PTx) procedure [ Time Frame: Immediate. During PTx procedure. ]
    Duration of PTx procedure - timed from skin incision until the surgeon notifies the anesthesia team to awaken the patient

  9. Duration taken for intraoperative parathyroid hormone (PTH) to normalize [ Time Frame: 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.

  10. Number of nights spent in the hospital after parathyroidectomy [ Time Frame: 0-72 hours after PTx procedure. ]
    Number of nights spent for postoperative recovery in the hospital after the surgical procedure.

  11. Number of 'false positive' tissues excised by surgeon [ Time Frame: Immediate to 10 days after PTx procedure. ]
    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

  12. Number of doctor visits/emergency department visits or hospital admissions [ Time Frame: Up to 6 months after PTx procedure. ]
    Number of doctor visits/emergency department visits or hospital admissions due to persistent hypercalcemia and/or associated symptoms after parathyroidectomy procedure

  13. Number of patients who have had repeat parathyroidectomy (PTx) procedure [ Time Frame: 6 - 12 months after PTx procedure. ]
    Number of patients with repeat PTx procedure performed after the current procedure



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04299425


Contacts
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Contact: Vanderbilt-Ingram Service L for Timely Access 800-811-8480 cip@vumc.org

Locations
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United States, Tennessee
Vanderbilt University Medical Center Recruiting
Nashville, Tennessee, United States, 37212
Contact: Teresa Melton    615-936-7423    teresa.melton@vumc.org   
Principal Investigator: Carmen C Solorzano, MD, FACS         
Sub-Investigator: Colleen M Kiernan, MD, MPH         
Sub-Investigator: Naira Baregamian, MD, FACS         
Sub-Investigator: Sarah L Rohde, MD         
Sponsors and Collaborators
Vanderbilt-Ingram Cancer Center
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Carmen C Solorzano, MD, FACS Vanderbilt University Medical Center
  Study Documents (Full-Text)

Documents provided by Carmen Solorzano, Vanderbilt-Ingram Cancer Center:
Informed Consent Form  [PDF] January 28, 2020

Publications:

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Responsible Party: Carmen Solorzano, Professor of Surgery Chair, Department of Surgery Director, Vanderbilt Endocrine Surgery, Vanderbilt-Ingram Cancer Center
ClinicalTrials.gov Identifier: NCT04299425    
Other Study ID Numbers: IRB 192486
5R01CA212147-02 ( U.S. NIH Grant/Contract )
First Posted: March 6, 2020    Key Record Dates
Last Update Posted: October 30, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Informed Consent Form and Clinical Study Report will be made available to other researchers as per the specified time-frame
Supporting Materials: Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: Clinical Study Report will be shared 6 months after publication of trial data and will be available till end date of trial. Informed Consent Form will be shared for a year after the primary completion date of the trial.
Access Criteria: Request for Individual Patient Data (IPD) - Informed consent Form and Clinical Study Report - will be reviewed by the principal investigator of this clinical trial, before granting access to IPD

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Carmen Solorzano, Vanderbilt-Ingram Cancer Center:
Parathyroidectomy
Intraoperative Parathyroid Identification
Near Infrared Autofluorescence
Persistent Hyperparathyroidism
Persistent Hypercalcemia
Failed Parathyroidectomy
Repeat Parathyroidectomy
Additional relevant MeSH terms:
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Adenoma
Parathyroid Neoplasms
Hypercalcemia
Hyperparathyroidism
Hyperparathyroidism, Primary
Hyperplasia
Pathologic Processes
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Parathyroid Diseases
Endocrine System Diseases
Calcium Metabolism Disorders
Metabolic Diseases
Water-Electrolyte Imbalance
Endocrine Gland Neoplasms
Neoplasms by Site
Head and Neck Neoplasms