DDAVP for Pituitary Adenoma
Recruiting now · Not applicable
Conditions studied: Cushing's Disease, Pituitary Adenoma
In brief
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.
Key facts
- Study ID
- NCT04569591
- Run by
- National Institute of Neurological Disorders and Stroke (NINDS)
- People needed
- 22
- Starts
- 2026-03-09
- Expected to finish
- 2028-02-26
- Last updated by the study team
- 2026-04-09
Who can join
Age: 8 and older, up to 99. Sex: any. Healthy volunteers: not accepted.
You may not qualify if…
- An individual who meets any of the following criteria will be excluded from participation in this study:
- Current pregnancy or lactation
- Glomerular filtration rate < 50 mL/min/1.73 m\^2, hepatorenal syndrome, history of urinary retention or post-liver or kidney transplantation.
- Hyponatremia (serum sodium below 135 mmol/L)
- Current diagnosis of angina, significant coronary artery disease, congestive heart failure, or SIADH due to risk of fluid overload and/or hyponatremia.
- Uncontrolled hypertension (blood pressure >150/95 mmHg) due to risk of further increase if fluid overload occurs.
- Uncontrolled, severe hypotension (sustained blood pressure <90/60), or symptomatic hypotension.
- Current use of any of the following medications:
- Vasopressors: phenylephrine, dopamine and vasopressin
- Drugs that can worsen hyponatremia: non-steroidal anti-inflammatory drugs (NSAIDs) within 4 days of testing, loop diuretics (bumetanide, ethacrynic acid, furosemide, torsemide), chlorpromazine, chlorpropamide, cisplatin, opiate agonists within 48 hours of testing, and/or vincristine.
- Drugs that interfere with DDAVP duration of action or potency: carbamazepine, lamotrigine, and/or tolvaptan
- Habitual or psychogenic polydipsia, due to increased risk of hyponatremia
- History of Type IIB von Willebrand s disease due to risk for thrombosis.
- Elevated blood glucose level above 200 mg/dL on the day of the scan prior to FDG administration.
- Known intolerance to DDAVP
- INCLUSION OF VULNERABLE PARTICIPANTS:
- Children: Children age 8 and older are included in this protocol. More than half of the subjects with CD requiring transsphenoidal surgery at the NIH are children. The knowledge gained by the use of DDAVP PET imaging in children with MR-invisible tumors will provide generalizable knowledge in the treatment of CD in this population. Children under the age of 8 usually require anesthesia for a PET scan, which involves greater risk. Therefore, children under the age of 8 will be excluded from participation.
- Pregnant or lactating women: Pregnant and lactating women will be excluded from participation. The PET radiopharmaceutical used in this study can be harmful to a developing fetus. Therefore women who are able to become pregnant will have a pregnancy test performed within 24 hours before PET imaging. Individuals will not be able to participate in PET scanning if the pregnancy test results positive.
Where it is running
- National Institutes of Health Clinical Center — Bethesda, Maryland, United States (enrolling)
Full record on ClinicalTrials.gov
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