RecruitingNot ApplicableNCT04569591

DDAVP for Pituitary Adenoma

Desmopressin (DDAVP) Stimulation for 18F-FDG-PET Detection of Pituitary Adenoma in Cushing's Disease

Sponsor

National Institute of Neurological Disorders and Stroke (NINDS)

Enrollment

22 participants

Start Date

Mar 9, 2026

Study Type

INTERVENTIONAL

Conditions

Pituitary Adenoma Cushing's Disease

Summary

This study is designed as a single institution trial. The study utilizes safe and clinically-validated tools for preoperative workup of patients with small pituitary tumors. DDAVP stimulation and 18F-labeled fluoro-deoxyglucose (FDG) uptake for PET-imaging will be used to detect MRI-negative pituitary adenomas in patients with Cushing s disease. Patients who have MRI-negative pituitary microadenomas will undergo FDG PET-imaging with DDAVP stimulation. Intravenous FDG will be given approximately four hours following DDAVP administration. Within 12 weeks after completion of the FDG high-resolution PET scan, patients will undergo surgical resection of the pituitary adenoma. Surgical and histological confirmation of adenoma location will be noted. All images will be read independently by neuroradiologists blinded to clinical and histopathological outcomes. The diagnostic and localization accuracy of PET-imaging will be assessed by comparing the PET findings with histopathology.

Eligibility

Min Age: 8 YearsMax Age: 99 Years

Plain Language Summary

Simplified for easier understanding

This study uses a special type of PET scan combined with a hormone called DDAVP to help locate small pituitary tumors in people with Cushing's disease — a condition where the body produces too much cortisol. The scan may find tumors that don't show up on a regular MRI. **You may be eligible if...** - You are 8 years old or older - You have been diagnosed with Cushing's disease and your MRI did not clearly show a tumor - You are able to undergo a PET scan without general anesthesia - You are willing and medically able to have surgery to remove the tumor within 24 weeks of the scan - Your liver function tests are normal - You have previously tolerated a DDAVP infusion **You may NOT be eligible if...** - You are pregnant or breastfeeding - You have poor kidney function, a history of urinary retention, or have had a kidney or liver transplant - You have low blood sodium (hyponatremia) - You have uncontrolled high or low blood pressure, heart failure, or coronary artery disease - You are taking certain medications like vasopressors, NSAIDs, or carbamazepine - Your blood sugar is above 200 mg/dL on the day of the scan - You have a known intolerance to DDAVP Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGDesmopressin acetate

Intravenous administration of ovine DDAVP (Desmopressin acetate 10 mcg) results in selective increase in ACTH activity of pituitary adenomas within two minutes and peaks between 10-15 minutes