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 @ 11:39 PM
Ignite Modification Date:
2025-12-24 @ 11:39 PM
NCT ID:
NCT02001051
Eligibility Criteria:
* INCLUSION CRITERIA:
* An individual with an adrenal neoplasm less than 5 cm in size with biochemically confirmed evidence of hypercortisolism (2 out of 3: dexamethasone suppression test (DST) \>3 mcgl/dL, elevated urine free cortisol, and/or morning adrenocorticotropic hormone (ACTH) \<2.2 pmol/l) without overt clinical signs and symptoms.
* Age greater than or equal to 18 years.
* Adults must be able to understand and sign the informed consent document.
* Patients must have laboratory and physical examination parameters within acceptable limits by standard of practice.
EXCLUSION CRITERIA:
* Biochemically and/or radiologically confirmed pheochromocytoma, hyperaldosteronism, or adrenocortical carcinoma.
* Nonfunctioning adrenal neoplasm.
* Pre-existing cancers and/or metastatic disease to the adrenal glands.
* Pregnancy and/or lactation.
* Lack of metabolic complications.
* Imaging features worrisome for malignancy (heterogeneous tumor, presence of calcifications, necrosis, \>10 Hounsfield units on an unenhanced computed tomography (CT) scan, and delayed washout of contrast).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
99 Years
Study:
NCT02001051
Study Brief:
Protocol Section:
NCT02001051