DDAVP for Pituitary Adenoma (NCT04569591) | Clinical Trial Compass
RecruitingNot Applicable
DDAVP for Pituitary Adenoma
United States22 participantsStarted 2026-03-09
Plain-language 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.
Who can participate
Age range
8 Years – 99 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The primary outcome measure will be defined as whether or not DDAVP-stimulated PET imaging demonstrates tumor in MRI-negative cases.
Timeframe: Baseline
Trial details
NCT IDNCT04569591
SponsorNational Institute of Neurological Disorders and Stroke (NINDS)
. 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
Exclusion criteria
. Current pregnancy or lactation
. Glomerular filtration rate \< 50 mL/min/1.73 m\^2, hepatorenal syndrome, history of urinary retention or post-liver or kidney transplantation.
. Hyponatremia (serum sodium below 135 mmol/L)
. 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.
. Uncontrolled, severe hypotension (sustained blood pressure \<90/60), or symptomatic hypotension.
. Current use of any of the following medications:
. Habitual or psychogenic polydipsia, due to increased risk of hyponatremia