Actively Recruiting
DDAVP for Pituitary Adenoma
Led by National Institute of Neurological Disorders and Stroke (NINDS) · Updated on 2026-04-09
22
Participants Needed
1
Research Sites
102 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
DDAVP for Pituitary Adenoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 8 years or older with biochemical evidence of Cushing's disease and MRI pituitary result negative or possible adenoma
- Pituitary MRI with and without contrast within 9 months before screening
- For newly diagnosed Cushing's disease, inferior petrosal sinus sampling (IPSS) is required
- Ability to undergo PET imaging without general anesthesia
- Ability to provide informed consent (or parent/guardian consent for minors)
- Clinical diagnosis of Cushing's disease documented in medical records
- Candidate for surgery and agrees to tumor removal within 24 weeks of PET imaging
- Normal liver function tests within 14 days before radiopharmaceutical injection (SGOT, SGPT ≤ 5x normal; bilirubin ≤ 2x normal)
- Tolerance of previous DDAVP infusion including during Cushing's disease workup
You will not qualify if you...
- Current pregnancy or breastfeeding
- Glomerular filtration rate < 50 mL/min/1.73 m², hepatorenal syndrome, urinary retention, or history of liver/kidney transplant
- Low blood sodium (hyponatremia, serum sodium below 135 mmol/L)
- Current angina, significant coronary artery disease, heart failure, or SIADH
- Uncontrolled high blood pressure (>150/95 mmHg)
- Uncontrolled severe low blood pressure (<90/60 mmHg) or symptomatic hypotension
- Current use of vasopressors or drugs that worsen hyponatremia or interfere with DDAVP action
- Habitual or psychogenic excessive water intake (polydipsia)
- History of Type IIB von Willebrand's disease
- Blood glucose above 200 mg/dL on day of scan before FDG
- Known intolerance to DDAVP
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892
Actively Recruiting
Research Team
C
Christina P Hayes, C.R.N.P.
CONTACT
P
Prashant Chittiboina, M.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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