DDAVP for Pituitary Adenoma

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age8-99
SponsorNational Institute of Neurological Disorders and Stroke (NINDS)

About this trial

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 criteria

Qualifiers

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

Disqualifiers

Current pregnancy or lactation

Glomerular filtration rate < 50 mL/min/1.73 m², 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.

Trial design

Treatments tested in this trial

  • Desmopressin acetate

Treatment groups

22 Participants
are divided into 1 treatment group