Neoplasms

All Conditions

Gland and Hormone Related Diseases

Symptoms and General Pathology

Nutritional and Metabolic Diseases

Rare Diseases

Adenoma

Hyperparathyroidism

Hyperplasia

Hyperparathyroidism, Primary

Parathyroid Neoplasms

Hypercalcemia

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Parathyroid Diseases

Endocrine System Diseases

Metabolic Diseases

Calcium Metabolism Disorders

Water-Electrolyte Imbalance

Endocrine Gland Neoplasms

Head and Neck Neoplasms

Primary Hyperparathyroidism

Parathyroid Carcinoma

All Drugs and Chemicals

Dermatologic Agents

Parathyroid Hormone

Parathyroid gland identification will be performed with PTeye using NIRAF detection technology as an adjunctive tool in patients who undergo parathyroidectomy (PTx).

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).

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.

NIRAF Detection Technology

Carmen C Solorzano, MD, FACS

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.

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.

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).

Only participants will be masked to the intervention.

Evaluating Impact of NIRAF Detection for Identifying Parathyroid Glands During Parathyroidectomy

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

Informed Consent Form and Clinical Study Report will be made available to other researchers as per the specified time-frame

Average number of parathyroid glands identified (Experimental Group: Glands identified with naked eye + NIRAF; Control Group: Glands identified with naked eye) per patient

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.

Number of frozen sections sent for analysis during the procedure to confirm potential parathyroid tissue

Duration of PTx procedure - timed from skin incision until the surgeon notifies the anesthesia team to awaken the patient

Number of nights spent for postoperative recovery in the hospital after the surgical 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

Number of patients with repeat PTx procedure performed after the current procedure.

National Cancer Institute (NCI)

Vanderbilt-Ingram Cancer Center

Professor of Surgery Chair, Department of Surgery Director, Vanderbilt Endocrine Surgery

Parathyroid gland identification will be performed with PTeye using NIRAF detection technology as an adjunctive tool in patients who undergo parathyroidectomy (PTx).

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.

NIRAF Detection Technology +

NIRAF Detection Technology -

Total

Age, Continuous

Sex: Female, Male

White

Black

Asian

Other

Race/Ethnicity, Customized

Non-Hispanic

Hispanic

United States

Region of Enrollment

Body Mass Index (BMI)

Diagnosis

Preoperative calcium (pg/dL)

Preoperative PTH (pg/mL)

Preoperative vitamin D

Procedure by intention

Only 63% of the cohort had follow-up for 6-months or longer, which may underestimate the rate of failure. The relatively small sample size may miss rare events such as operative failure. Additionally, inter-variability amongst the two surgeons and their surgical approaches adds more complexity. Lastly, these findings may only be generalizable to higher volume centers with more experienced surgeons.

Dr. Carmen C Solorzano

Average Number of Parathyroid Glands Identified With High Confidence Per Patient

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

Number of Frozen Sections Sent for Analysis

Duration of Parathyroidectomy (PTx) Procedure

Number of Participants Stratified by Duration of Hospital Stay

Only the NIRAF Detection Technology + arm was included in the analysis to calculate the rate of false positives by the device. Since the NIRAF Detection Technology - did not use the device that arm was not included.

Number of 'False Positive' Tissues Excised by Surgeon

Nearly all patients attended their first follow-up appointment (5-14 days post-operation), however about 30 patients were lost for long-term follow-up.

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

Overall Study

Musculoskeletal Diseases

Diseases and Abnormalities at or Before Birth

Bone Diseases

Pseudohypoparathyroidism

Pseudopseudohypoparathyroidism

Multiple Endocrine Neoplasia

Multiple Endocrine Neoplasia Type 1

Neoplasms, Multiple Primary

Syndrome

Neoplastic Syndromes, Hereditary

Genetic Diseases, Inborn

Bone Diseases, Metabolic

Metabolism, Inborn Errors

Metal Metabolism, Inborn Errors

Bone Density Conservation Agents

Calcium

Calcium, Dietary

Parathyroid (and related disorders) will be evaluated and their biospecimens collected to define the molecular signature and clinical spectrum of their disorder

Craig S Cochran, R.N.

Smita Jha, M.D.

For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)

Background:

Parathyroid disorders are very common in the general population and include disorders of parathyroid excess, deficiency, or defects in parathyroid hormone (PTH) signaling. PTH, the main secretory product of parathyroid glands is responsible for regulation of calcium-phosphate homeostasis.

Objective:

i) To investigate the cause of parathyroid disorders

ii) To describe evolution, natural history, and longitudinal trends of parathyroid and related disorders seen in syndromic presentations like multiple endocrine neoplasia, hyperparathyroidism-jaw tumor syndrome

Eligibility:

People ages 6 months older who have, are at risk of having, or are related to a person with a parathyroid or related disorder.

Design:

Participants will be screened with a review of their medical records.

Participants will be seen, tested, and treated by doctors based on their condition. Their visits may be in person or via telehealth.

Participants will complete questionnaires. They will answer questions about their physical, mental, and social health.

Participants may give samples such as saliva, blood, urine, or stool.

Participants may give cheek cell samples. They will do this using a cheek swab or by spitting into a cup.

Adult participants may give a skin biopsy. For this, a small bit of skin is removed with a punch tool.

Participants may have medical photos taken.

If participants have surgery during the course of their regular care either at the NIH

or at a different hospital or doctor s office, researchers will ask for some of the leftover

tissue.

Participants will be in the study as long as they are being seen by their doctor.

Study Description:

Patients with confirmed, suspected or at risk of developing parathyroid disorders will be provided standard of care testing for their condition. Data obtained during the testing will be used for research. Additionally, samples may be collected for research.

Objectives:

* To investigate the cause of the disease and its associated manifestations, possibly genetic in participants with parathyroid and related disorder(s)
* To identify biomarkers of the various parathyroid disorder(s) and associated manifestations by performing molecular profiling of available biospecimens
* To describe evolution, natural history and longitudinal trends of parathyroid and related disorders including the associated extra- parathyroid manifestations seen in these disorders, for example, Zollinger-Ellison syndrome, gastro-entero-pancreatic neuroendocrine tumors, kidney, jaw, pituitary and uterine tumors.
* To investigate the natural history of parathyroid disorders and associated manifestations during pregnancy
* To characterize the morbidity and mortality in participants with parathyroid and related disorders and investigate its association with extra-parathyroidal manifestations.
* To investigate long-term risks and benefits with standard of care testing and therapy for parathyroid and associated extra-parathyroidal manifestations.

Natural History Study of Parathyroid Disorders

Participants will undergo standard clinical evaluations for their condition. Data obtained during these evaluations will be retained for purposes of the primary objective, for analysis of secondary objectives, and for future research. There are no mandatory study procedures for this protocol.

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

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 rely solely on her/his surgical experience in identifying the parathyroid glands during the operations.

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.

PTeye

Anee Sophia Jackson

Hunter Underwood

Paul Gauger

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.

Only participants will be masked to the intervention

Intraoperative levels, (e.g. baseline, excision, 5 minutes).

Repeat surgeries are documented as binary (yes or no)

Duration taken to identify 1st parathyroid gland in PTx procedure - timed from skin incision to finding parathyroid gland in each participant.

Duration taken to identify last parathyroid gland in PTx procedure - timed from skin incision to finding the last parathyroid gland in each participant.

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.

Overall number of parathyroid glands identified (Experimental Group: Glands identified with naked eye + NIRAF; Control Group: Glands identified with naked eye)

Number of patients with repeat PTx procedure performed after the current procedure

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Evaluating Impact of NIRAF Detection for Identifying Parathyroid Glands During Parathyroidectomy	NCT04299425	Parathyroid Ade... Parathyroid Neo... Parathyroid Hyp... Parathyroid Can... Hypercalcemia Primary Hyperpa...	NIRAF Detection...	18 Years - 99 Years	Vanderbilt-Ingram Cancer Center
Natural History Study of Parathyroid Disorders	NCT04969926	Parathyroid Can... Primary Hyperpa... Pseudohypoparat... Inheritable Bon... Multiple Endocr...		6 Months - 100 Years	National Institutes of Health Clinical Center (CC)
Evaluating Impact of Near Infrared Autofluorescence (NIRAF) Detection for Identifying Parathyroid Glands During Parathyroidectomy	NCT05022641	Parathyroid Ade... Parathyroid Neo... Parathyroid Can... Hypercalcemia Primary Hyperpa...	PTeye	18 Years -	University of Michigan
Evaluating Impact of NIRAF Detection for Identifying Parathyroid Glands During Parathyroidectomy	NCT04299425	Parathyroid Ade... Parathyroid Neo... Parathyroid Hyp... Parathyroid Can... Hypercalcemia Primary Hyperpa...	NIRAF Detection...	18 Years - 99 Years	Vanderbilt-Ingram Cancer Center
Evaluating Impact of Near Infrared Autofluorescence (NIRAF) Detection for Identifying Parathyroid Glands During Parathyroidectomy	NCT05022641	Parathyroid Ade... Parathyroid Neo... Parathyroid Can... Hypercalcemia Primary Hyperpa...	PTeye	18 Years -	University of Michigan

Spots Global Cancer Trial Database for parathyroid cancer