| NCT ID | NCT04569591 |
| Status | Recruiting |
| Phase | — |
| Sponsor | National Institute of Neurological Disorders and Stroke (NINDS) |
| Condition | Cushing's Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 22 participants |
| Start Date | 2026-03-09 |
| Primary Completion | 2028-02-26 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 22 participants in total. It began in 2026-03-09 with a primary completion date of 2028-02-26.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
* INCLUSION CRITERIA: In order to be eligible to participate in this study, an individual must meet all of the following criteria: 1. 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") 2. MRI of the pituitary gland with and without contrast obtained within 9 months of screening 3. For newly diagnosed Cushing s disease cases, IPSS is required. 4. Ability to undergo PET-imaging without general anesthesia 5. Ability to provide informed consent for study participation (parents or guardians in the case of minors) 6. Clinical diagnosis of Cushing s disease based on documented medical records 7. Surgical candidate for and subject agrees to resection of ACTH producing pituitary adenoma within 24 weeks of PET-imaging 8. 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 9. Tolerance of a previous infusion of DDAVP, including as part of workup and diagnosis of Cushing's disease EXCLUSION CRITERIA: An individual who meets any of the following criteria will be excluded from participation in this study: 1. Current pregnancy or lactation 2. Glomerular filtration rate \< 50 mL/min/1.73 m\^2, hepatorenal syndrome, history of urinary retention or post-liver or kidney transplantation. 3. Hyponatremia (serum sodium below 135 mmol/L) 4. Current diagnosis of angina, significant coronary artery disease, congestive heart failure, or SIADH due to risk of fluid overload and/or hyponatremia. 5. Uncontrolled hypertension (blood pressure \>150/95 mmHg) due to risk of further increase if fluid overload occurs. 6. Uncontrolled, severe hypotension (sustained blood pressure \<90/60), or symptomatic hypotension. 7. 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 8. Habitual or psychogenic polydipsia, due to increased risk of hyponatremia 9. History of Type IIB von Willebrand s disease due to risk for thrombosis. 10. Elevated blood glucose level above 200 mg/dL on the day of the scan prior to FDG administration. 11. Known intolerance to DDAVP INCLUSION OF VULNERABLE PARTICIPANTS: * 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. * 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.
Contact & Investigator
Prashant Chittiboina, M.D.
PRINCIPAL INVESTIGATOR
National Institute of Neurological Disorders and Stroke (NINDS)
Frequently Asked Questions
Who can join the NCT04569591 clinical trial?
This trial is open to participants of all sexes, aged 8 Years or older, up to 99 Years, studying Cushing's Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04569591 currently recruiting?
Yes, NCT04569591 is actively recruiting participants. Contact the research team at christi.hayes@nih.gov for enrollment information.
Where is the NCT04569591 trial being conducted?
This trial is being conducted at Bethesda, United States.
Who is sponsoring the NCT04569591 clinical trial?
NCT04569591 is sponsored by National Institute of Neurological Disorders and Stroke (NINDS). The principal investigator is Prashant Chittiboina, M.D. at National Institute of Neurological Disorders and Stroke (NINDS). The trial plans to enroll 22 participants.