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

This is an interventional supportive care trial for Parathyroid Gland Adenoma Read More

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)