DDAVP for Pituitary Adenoma
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age8-99
SponsorNational Institute of Neurological Disorders and Stroke (NINDS)
About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Current pregnancy or lactation
Glomerular filtration rate < 50 mL/min/1.73 m², 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.
Trial design
Design model
Single group
Treatments tested in this trial
Desmopressin acetate
DrugIntravenous administration of ovine DDAVP (Desmopressin acetate 10 mcg) results in selective increase in ACTH activity of pituitary adenomas within two minutes and peaks between 10-15 minutes
Treatment groups
22 Participants
are divided into 1 treatment groupGroup A: 1Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
The primary outcome measure will be defined as whether or not DDAVP-stimulated PET imaging demonstrates tumor in MRI-negative cases.
This endpoint will help justify whether pituitary adenomas that are invisible on MRI can be seen via another modality in order to improve tumor detection and preoperative planningdemonstrates tumor in MRI-negative cases. This will be demonstrated by assessing the accuracy and sensitivity of 18F-FDG high-resolution PET-imaging detection of ACTH-adenomas that could not be reliably detected on MR-imaging. Measures will include determining the rate of true tumor detection using PET-imaging compared to histologically-confirmed tumor location.
Time frame
BaselineSecondary outcomes
1
To assess the accuracy of FDG high-resolution PET-imaging localization of ACTH-adenomas in CD compared to surgical and histologic localization.
This endpoint will help justify not only the ability to detect tumor that cannot otherwise be detected on MRI but also the true accuracy, in terms of anatomic location, of such detection (compared to clinical gold standard of histology)
Time frame
BaselineSponsors and contacts
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Source ClinicalTrials.gov