Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 12:19 PM
Ignite Modification Date:
2025-12-24 @ 12:19 PM
NCT ID:
NCT04305561
Eligibility Criteria:
Inclusion Criteria:
* 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 Criteria:
* 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).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04305561
Study Brief:
Protocol Section:
NCT04305561