Taking people in United StatesNo phase

DDAVP and PET scan to locate small pituitary tumors in Cushing's disease

Tests DDAVP with a PET scan to find small pituitary tumors in Cushing's disease.

Key facts

Who runs it: National Institute of Neurological Disorders and Stroke (NINDS)
Where: Bethesda, United StatesSee the site
Trial code: NCT04569591
Registry title: DDAVP for Pituitary Adenoma
Status: Recruiting
People taking part: 22 people, planned
Started: 9 Mar 2026
Expected to end: 26 Feb 2028
Type of study: Interventional
Treatments tested: Desmopressin acetate
Record updated: 9 April 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for people aged 8 or older with Cushing's disease whose pituitary MRI shows no tumor or only a possible tumor. They will have a PET scan after DDAVP and then surgery.

Age: 8 years or older (up to 99 years)
Sex: All sexes can join.
Disease stage: Cushing's disease proven by blood or urine tests, with a pituitary MRI result of negative or possible adenoma. MRI done within 9 months of screening.
Earlier treatment: Must have tolerated a previous DDAVP infusion. Must agree to surgery to remove the pituitary tumor within 24 weeks of the PET scan. People with newly diagnosed disease need an IPSS test.
Biomarker or test result: Normal liver function: SGOT and SGPT up to 5 x the upper limit of normal, bilirubin up to 2 x the upper limit of normal.

Main reasons for not taking part

Pregnant or breastfeeding
Low blood sodium (below 135 mmol/L) or kidney problems (GFR below 50)
Heart disease, uncontrolled high blood pressure, or severe low blood pressure
Taking certain drugs, such as vasopressors, loop diuretics, carbamazepine, lamotrigine or tolvaptan
Blood glucose above 200 mg/dL (11.1 mmol/L) on scan day, or known intolerance to DDAVP

The registry criteria, word for word

Show all 24 criteriaShow less

Who cannot take part

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
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
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
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
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

Other criteria

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

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

Are you between 8 and 99 years old?

Where in United States

National Institutes of Health Clinical CenterBethesda, United StatesContact: Christina P Hayes, C.R.N.P.Taking people

About the trial

What the trial wants to find out

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.

The group in the trial

1Treatment being tested
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
Treatment: Desmopressin acetate