DDAVP for Pituitary Adenoma

Part of paid clinical trials in Bethesda, Maryland.

Sponsor
National Institute of Neurological Disorders and Stroke (NINDS)
Study ID
NCT04569591
Status
Recruiting
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Conditions

  • Cushing's Disease
  • Pituitary Adenoma

Eligibility Criteria

Sex
ALL
Age
8 Years - 99 Years
Healthy Volunteers
Not accepted

Interventions

  • Desmopressin acetate — DRUG
    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

Study Details

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 Dates

Start date
Mar 9, 2026
Status verified
Apr 2026
Primary completion
Feb 26, 2028
Completion
Feb 26, 2028

Study Design

Enrollment
22 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: 1
    patients aged 8 or older with Cushing's Disease who are surgical candidates for resection of ACTH producing pituitary adenoma within 12 weeks of PET imaging

Primary Outcome Measure

The primary outcome measure will be defined as whether or not DDAVP-stimulated PET imaging demonstrates tumor in MRI-negative cases. [ Time Frame: Baseline ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
National Institutes of Health Clinical CenterBethesdaMaryland20892
For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)
[email protected]
800-411-1222

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By research site
National Institutes of Health Clinical Center· Bethesda, MD

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