DDAVP for Pituitary Adenoma
NCT04569591 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 22
Last updated 2026-04-09
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.
Conditions
- Cushing's Disease
- Pituitary Adenoma
Interventions
- DRUG
-
Desmopressin 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
Sponsors & Collaborators
-
National Institute of Neurological Disorders and Stroke (NINDS)
lead NIH
Principal Investigators
-
Prashant Chittiboina, M.D. · National Institute of Neurological Disorders and Stroke (NINDS)
Study Design
- Allocation
- NA
- Purpose
- DIAGNOSTIC
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 8 Years
- Max Age
- 99 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-03-09
- Primary Completion
- 2028-02-26
- Completion
- 2028-02-26
Countries
- United States
Study Locations
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