NCT04569591Recruiting

DDAVP for Pituitary Adenoma

Desmopressin (DDAVP) Stimulation for 18F-FDG-PET Detection of Pituitary Adenoma in Cushing's Disease

Source: ClinicalTrials.gov · Last updated 9 Apr 2026

Brief summary (registry, in English)

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.

Status (registry): Recruiting
Study type: Interventional
Enrollment: 22 (estimated)
First submitted: 29 Sept 2020
Start date: 9 Mar 2026
Primary completion date: 26 Feb 2028
Lead sponsor: National Institute of Neurological Disorders and Stroke (NINDS)
NCT number: NCT04569591

What you commit to

Study type: Interventional
Planned participants: 22
From 9 Mar 2026 to the primary completion date, 26 Feb 2028
1 site in 1 country
Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

Current use of any of the following medications:
- Vasopressors: phenylephrine, dopamine and vasopressin
- Drugs that can worsen hyponatremia: non-steroidal anti-inflammatory drugs (NSAIDs) within 4 days of testing, loop diuretics (bumetanide, ethacrynic acid, furosemide, torsemide), chlorpromazine, chlorpropamide, cisplatin, opiate agonists within 48 hours of testing, and/or vincristine.
- Drugs that interfere with DDAVP duration of action or potency: carbamazepine, lamotrigine, and/or tolvaptan

Other illness

Glomerular filtration rate \< 50 mL/min/1.73 m\^2, hepatorenal syndrome, history of urinary retention or post-liver or kidney transplantation.
Current diagnosis of angina, significant coronary artery disease, congestive heart failure, or SIADH due to risk of fluid overload and/or hyponatremia.
Uncontrolled hypertension (blood pressure \>150/95 mmHg) due to risk of further increase if fluid overload occurs.
History of Type IIB von Willebrand s disease due to risk for thrombosis.

Lab values

Hyponatremia (serum sodium below 135 mmol/L)
Elevated blood glucose level above 200 mg/dL on the day of the scan prior to FDG administration.

Age

Children: Children age 8 and older are included in this protocol. More than half of the subjects with CD requiring transsphenoidal surgery at the NIH are children. The knowledge gained by the use of DDAVP PET imaging in children with MR-invisible tumors will provide generalizable knowledge in the treatment of CD in this population. Children under the age of 8 usually require anesthesia for a PET scan, which involves greater risk. Therefore, children under the age of 8 will be excluded from participation.

Other

An individual who meets any of the following criteria will be excluded from participation in this study:
Current pregnancy or lactation
Uncontrolled, severe hypotension (sustained blood pressure \<90/60), or symptomatic hypotension.
Habitual or psychogenic polydipsia, due to increased risk of hyponatremia
Known intolerance to DDAVP
- INCLUSION OF VULNERABLE PARTICIPANTS:
Pregnant or lactating women: Pregnant and lactating women will be excluded from participation. The PET radiopharmaceutical used in this study can be harmful to a developing fetus. Therefore women who are able to become pregnant will have a pregnancy test performed within 24 hours before PET imaging. Individuals will not be able to participate in PET scanning if the pregnancy test results positive.

Criteria the registry did not label

INCLUSION CRITERIA:
- In order to be eligible to participate in this study, an individual must meet all of the following criteria:
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
Ability to provide informed consent for study participation (parents or guardians in the case of minors)
Clinical diagnosis of Cushing s disease based on documented medical records
Surgical candidate for and subject agrees to resection of ACTH producing pituitary adenoma within 24 weeks of PET-imaging
Normal liver function as evidenced by liver enzyme tests completed within 14 days before injection of radiopharmaceutical: SGOT, SGPT \<= 5 x upper limit of normal; bilirubin \<= 2 x upper limit of normal
Tolerance of a previous infusion of DDAVP, including as part of workup and diagnosis of Cushing's disease

Age in the registry: 8 years to 99 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

Site	City	Country	Site status
National Institutes of Health Clinical Center Coordinator of this site? Confirm its status	Bethesda	United States	Recruiting

This page is information, not medical advice. Discuss any trial with your doctor.