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COMPLETEDNA

Omission of Intact Parathyroid Hormone Testing During Surgery in Treating Patients With Primary Hyperparathyroidism

Single-Arm, Non-inferiority Study of Omission of Intraoperative Intact Parathyroid Hormone (PTH) During Minimally Invasive Parathyroidectomy for Primary Hyperparathyroidism

NCT03011736•Roswell Park Cancer Institute

View on ClinicalTrials.gov

Summary

This clinical trial studies the omission of intact parathyroid hormone testing during surgery in treating patients with primary hyperparathyroidism. Omission of intact parathyroid hormone testing during parathyroid gland removal may help patients with primary hyperparathyroidism to decrease their time under anesthesia, and decrease the overall time and cost of surgery.

Detailed Description

PRIMARY OBJECTIVES: I. Determine the non-inferiority of omission of parathyroid hormone (PTH) in patients who meet the biochemical and radiological criteria compared to current standard of care (i.e. use of intraoperative parathyroid hormone testing). SECONDARY OBJECTIVES: I. Cost-analysis to determine savings of omission of intraoperative PTH testing. OUTLINE: Patients undergo standard minimally invasive parathyroidectomy without PTH testing during surgery. After completion of study, patients are followed up at 2 weeks.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Positive 4 dimensional computed tomography (4D CT) for single gland (adenoma) primary hyperparathyroidism
•Preoperative serum calcium levels \>= 10.9 mg/dL
•Preoperative parathyroid hormone (PTH) elevated beyond normal range or inappropriately high for associated calcium level
•Patient has no history of prior neck surgery or external radiation to neck for malignant conditions
•Have an Eastern Cooperative Oncology Group (ECOG) performance status of =\< 2
•Subject or legal representative must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure

Exclusion Criteria

•Patient has recurrent hyperparathyroidism
•4D CT positive for multiple gland disease
•Patient has inability to tolerate 4D CT scan (for example; contrast intravenous (IV) allergy, claustrophobia, renal disease)
•Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
•Pregnant or nursing female subjects; may be determined in the preoperative evaluation
•Unwilling or unable to follow protocol requirements
•Any condition which in the investigator's opinion deems the subject an unsuitable candidate to undergo observational study (may also include preoperative testing results including electrocardiography \[EKG\], chest x-ray, or pulmonary function tests that preclude a wide excision in the operating room)

Locations (1)

Roswell Park Cancer Institute

Buffalo, New York, United States

Key Dates

Start Date

May 12, 2016

Primary Completion Date

July 12, 2018

Completion Date

December 24, 2018

Last Updated

August 12, 2021

Enrollment

ACTUAL participants

Conditions

Parathyroid Gland AdenomaPrimary Hyperparathyroidism

Interventions

Laboratory Biomarker Analysis

OTHER

Parathyroidectomy

PROCEDURE

Accuracy of 18F-Fluorocholine PET/MR and NeuroEXPLORER PET/CT Imaging for Localization of Parathyroid Tumors

NCT07444723

Primary HyperparathyroidismParathyroid Cancer+3 more

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COMPLETED

A Retrospective Analysis of the Diagnostic Performance of 11C-choline PET/CT in Primary Hyperparathyroidism

NCT04608253

Primary HyperparathyroidismPrimary Hyperparathyroidism Due to Adenoma

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 12, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Omission of Intact Parathyroid Hormone Testing During Surgery in Treating Patients With Primary Hyperparathyroidism

Inclusion Criteria

Exclusion Criteria

Accuracy of 18F-Fluorocholine PET/MR and NeuroEXPLORER PET/CT Imaging for Localization of Parathyroid Tumors

A Retrospective Analysis of the Diagnostic Performance of 11C-choline PET/CT in Primary Hyperparathyroidism

Gait and Balance Parameters Before and After Parathyroidectomy in Patients With Primary Hyperparathyroidism

Effect of Mechanical Loading on vBMD and Geometry in Patients With Primary Hyperparathyroidism

Treatment of Primary Hyperparathyroidism With Denosumab and Cinacalcet.

Surgical Outcomes in Patients With Primary Hyperparathyroidism and Unclear Preoperative Localisation Studies