Status:
COMPLETED
Preoperative Localization Strategies in Primary Hyperparathyroidism
Lead Sponsor:
Odense University Hospital
Conditions:
Primary Hyperparathyroidism
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of this project is to examine, in a non-inferiority study, whether the combination of conventional ultrasound and contrast-enhanced ultrasound (CEUS) can replace the radiation-based imagin...
Detailed Description
The human body has four parathyroid glands. These are located in the neck at the backside of the thyroid gland. The four glands produce parathyroid hormone which regulates the amount of calcium in the...
Eligibility Criteria
Inclusion
- Patients 18 years and older with primary hyperparathyroidism (defined as an ionized calcium level above the upper reference level and a concomitant parathyroid hormone level in or above the upper third of the reference interval with no other known reason for the hyperparathyroid hypercalcemia) referred to the Department of ORL, Head and Neck Surgery at Odense University Hospital for parathyroidectomy.
Exclusion
- Allergy to the contrast agent SonoVue®.
- Not legally competent.
- Does not read or speak Danish.
- Other causes of hypercalcemia (e.g. familial hypocalciuric hypercalcemia, pharmacologically or neoplastically induced hypercalcemia, secondary or tertiary hypercalcemia, uncontrolled hyperthyroidism, adrenal insufficiency, granulomatous diseases).
- Persistent or recurrent hyperparathyroidism.
- Previous surgery to the thyroid or the parathyroid glands.
- Current malignancy.
- Breastfeeding.
- Pregnancy.
- Contraindications to the use of SonoVue® (right-to-left shunts, severe pulmonary hypertension (pulmonary pressure \>90 mmHg), uncontrolled systemic hypertension, adult respiratory distress syndrome, recent acute coronary syndrome, clinically unstable ischaemic cardiac disease within the last seven days, severe heart rhythm disorders, acute heart failure, or chronic heart failure class III or IV according to the New York Heart Association).
Key Trial Info
Start Date :
September 5 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2021
Estimated Enrollment :
172 Patients enrolled
Trial Details
Trial ID
NCT04305561
Start Date
September 5 2019
End Date
December 31 2021
Last Update
April 14 2022
Active Locations (1)
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1
Odense University Hospital
Odense C, Denmark, 5000