NCT06344143 · The Cleveland Clinic
Detecting Mild Autonomous Cortisol Secretion in Patients With Adrenal Incidentaloma
(MACS)
What this study is about
The aim of the proposed study is to estimate the incidence of Mild Autonomous Cortisol Secretion (MACS) in patients with Adrenal Incidentaloma (AI) and evaluate the available diagnostic tests to determine the most sensitive and specific combination of tests for assessing MACS from adrenal adenoma for prediction of the phenotype associated with cortisol excess.
View original scientific description
The aim of the proposed study is to estimate the incidence of Mild Autonomous Cortisol Secretion (MACS) in patients with Adrenal Incidentaloma (AI) and evaluate the available diagnostic tests to determine the most sensitive and specific combination of tests for assessing MACS from adrenal adenoma for prediction of the phenotype associated with cortisol excess. As well as following the patients for 4 years and see if anything changes.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Patients ages 18 years and older.
- Presence of adrenal incidentaloma by cat scan (CT) or magnetic resonance imaging (MRI) examination.
- 1-mg Dexamethasone suppression test cortisol ≤ 5 μg/dL with adequate dexamethasone level.
Exclusion criteria
- 1-mg Dexamethasone suppression test cortisol \> 5 μg/dL with adequate dexamethasone level. Patients who fail to suppress below this level will be considered to have Cushing's syndrome and will be referred for appropriate treatment.
- Current or recent (3 months) history of use of glucocorticoid medication (including joint injections of steroids).
- History of uncontrolled hypertension or history of hypertension with more than 2 medications.
- History of uncontrolled type 2 Diabetes Mellitus or history of diabetes mellitus with A1c\>7.5.
- Known History of osteoporosis
- Documented Clinical Cushing's disease.
- Clinical suspicion of adrenal carcinoma.
- History of alcohol abuse/dependence.
- History of cirrhosis of liver.
- History of hepatitis B or C infection regardless of treatment.
- History of type 1 diabetes.
- History of hemochromatosis.
- History of autoimmune hepatitis.
- History of Wilson's disease.
Where
- Cleveland, Ohio
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jan 8, 2026 · Source of record for eligibility and locations