DDAVP for Pituitary Adenoma (NCT04569591) | Clinical Trial Compass
RecruitingNot Applicable
DDAVP for Pituitary Adenoma
United States22 participantsStarted 2026-03-09
Plain-language 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.
Who can participate
Age range8 Years – 99 Years
SexALL
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Inclusion criteria
✓. Subjects aged 8 or older with biochemical evidence of Cushing s disease and a clinical MRI pituitary neuroradiology result of negative or possible adenoma (e.g. "no tumor" or "possible tumor")
✓. MRI of the pituitary gland with and without contrast obtained within 9 months of screening
✓. For newly diagnosed Cushing s disease cases, IPSS is required.
✓. Ability to undergo PET-imaging without general anesthesia
✓. Ability to provide informed consent for study participation (parents or guardians in the case of minors)
✓. Clinical diagnosis of Cushing s disease based on documented medical records
✓. Surgical candidate for and subject agrees to resection of ACTH producing pituitary adenoma within 24 weeks of PET-imaging
✓. Normal liver function as evidenced by liver enzyme tests completed within 14 days before injection of radiopharmaceutical: SGOT, SGPT \<= 5 x upper limit of normal; bilirubin \<= 2 x upper limit of normal
Exclusion criteria
What they're measuring
1
The primary outcome measure will be defined as whether or not DDAVP-stimulated PET imaging demonstrates tumor in MRI-negative cases.
Timeframe: Baseline
Trial details
NCT IDNCT04569591
SponsorNational Institute of Neurological Disorders and Stroke (NINDS)
✕. 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:
✕. Habitual or psychogenic polydipsia, due to increased risk of hyponatremia