Actively Recruiting
Desmopressin (DDAVP) Stimulation for 18F-FDG-PET Detection of Pituitary Adenoma in Cushing's Disease
Led by National Institute of Neurological Disorders and Stroke (NINDS) · Updated on 2026-04-09
22
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the use of DDAVP-stimulated 18F-fluorodeoxyglucose (FDG) PET imaging to detect MRI-negative pituitary adenomas in patients with Cushing's disease. This single institution trial focuses on subjects with small pituitary tumors who have biochemical evidence of Cushing's disease but show negative or unclear results on standard MRI scans. The goal is to improve detection and localization of these tumors to aid surgical planning and treatment. Participants aged 8 years and older who are surgical candidates for resection of ACTH-producing pituitary adenomas will receive intravenous DDAVP (Desmopressin acetate 10 mcg), followed approximately four hours later by FDG administration for high-resolution PET imaging. Within 24 weeks after PET imaging, subjects will undergo surgical removal of the tumor. PET images will be independently reviewed by neuroradiologists who are unaware of surgical or histological findings to assess the accuracy of DDAVP-stimulated PET imaging compared to MRI and surgical results. During the study, participants will have MRI scans within 9 months prior to screening, PET imaging with DDAVP stimulation, and surgical evaluation of the pituitary adenoma. Researchers will compare PET imaging results with surgical and histological confirmation of tumor location to determine diagnostic accuracy. Safety and liver function will be monitored, and eligibility includes tolerance to previous DDAVP administration. The primary outcome is detection of tumors by PET imaging in MRI-negative cases, with secondary outcomes assessing localization accuracy compared to surgery and histology.
CONDITIONS
Brief Title
DDAVP for Pituitary Adenoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Subjects aged 8 or older with biochemical evidence of Cushing's disease and MRI showing negative or possible pituitary adenoma
- MRI of the pituitary gland with and without contrast obtained within 9 months of screening
- For newly diagnosed cases, inferior petrosal sinus sampling (IPSS) is required
- Ability to undergo PET imaging without general anesthesia
- Ability to provide informed consent (parents or guardians for minors)
- Clinical diagnosis of Cushing's disease based on medical records
- Surgical candidate agreeing to resection of ACTH-producing pituitary adenoma within 24 weeks of PET imaging
- Normal liver function with enzyme tests within 14 days before radiopharmaceutical injection
- Tolerance of previous DDAVP infusion including during diagnosis workup
You will not qualify if you...
- Current pregnancy or breastfeeding
- Glomerular filtration rate less than 50 mL/min/1.73 m², hepatorenal syndrome, urinary retention, or history of liver/kidney transplant
- Hyponatremia (serum sodium below 135 mmol/L)
- Current angina, significant coronary artery disease, congestive heart failure, or SIADH
- Uncontrolled high blood pressure above 150/95 mmHg
- Uncontrolled severe low blood pressure below 90/60 mmHg or symptomatic hypotension
- Current use of vasopressors or drugs that worsen hyponatremia or interfere with DDAVP
- Habitual or psychogenic excessive water intake
- History of Type IIB von Willebrand's disease
- Blood glucose above 200 mg/dL on scan day before FDG administration
- Known intolerance to DDAVP
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 1 day
Participants receive DDAVP stimulation followed by FDG injection and undergo high-resolution PET imaging to detect MRI-negative pituitary adenomas.
1 visit (in-person)
Duration - Up to 24 weeks
Within 24 weeks after PET imaging, participants undergo surgical resection of the pituitary adenoma with surgical and histological confirmation of tumor location.
1 visit for surgery and immediate postoperative care
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.
P
Prashant Chittiboina, M.D.
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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