An interventional study of Desmopressin acetate in Cushing's Disease and Pituitary Adenoma, sponsored by National Institute of Neurological Disorders and Stroke (NINDS). Recruiting at 1 site in United States. Open to participants aged 8 Years to 99 Years. Per ClinicalTrials.gov, last updated 2026-04-09.
Sponsored by National Institute of Neurological Disorders and Stroke (NINDS) · Not applicable, Interventional, and Diagnostic
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.
Study Description:
This study is designed as a single institution trial. The study utilizes safe and clinically-validated tools for preoperative workup of subjects with small pituitary tumors. DDAVP stimulation and 18F-labeled fluorodeoxyglucose (FDG) uptake for PET-imaging will be used to detect MRInegative pituitary adenomas in subjects with Cushing s disease. Subjects who have MRI-negative pituitary microadenomas will undergo FDG PETimaging with DDAVP stimulation. Intravenous FDG will be given approximately four hours following DDAVP administration. Within 24 weeks after completion of the FDG high-resolution PET scan, subjects 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.
Objectives:
Cushing s disease (CD) affects 3,000 people in the United States every year and results in significant morbidity and early mortality. The disease is caused by millimeter sized pituitary microadenomas (corticotropinomas) that secrete adrenocorticotropic hormone (ACTH). Surgical resection of corticotropinomas remains the most effective treatment strategy. Preoperative magnetic resonance imaging (MRI) can detect microadenomas in approximately 50-80% of subjects. Subjects with microadenomas invisible on MR imaging are exposed to more invasive explorations of the sella with fewer instances of hormone remission and higher complications. Corticotropinomas can be detected by FDG positron emission tomography (PET) in 50% of subjects. Prior work by us suggests that secretagogue stimulation with corticotropin-releasing hormone (CRH) leads to increased FDG uptake and improved PET detection of pituitary microadenomas.
Since, CRH is no longer available, we will use DDAVP which has a similar biological activity to CRH. If validated, DDAVP-stimulated FDG-PET imaging could provide a complementary imaging modality to improve visualization of ACTH-secreting microadenomas and surgical planning.
Primary Objective:
The primary objective of this study is to determine the detection rate of MRI-negative pituitary adenomas in subjects with Cushing's disease by DDAVP-stimulated FDG PET imaging. We will analyze whether or not DDAVP-stimulated PET imaging demonstrates
tumor in MRI-negative cases by assessing the accuracy and sensitivity of high-resolution FDG PET-imaging detection of ACTH-adenomas that could not be reliably detected on MR-imaging.
Secondary Objectives:
To assess the accuracy of FDG high-resolution PETimaging localization of ACTH-adenomas in CD compared to surgical and
histologic localization. This will be achieved by comparing actual tumor location confirmed by histological findings during surgical resection to the location predicted by PET- and MR-imaging within subjects.
Endpoints:
Primary Endpoint: The primary outcome measure will be defined as whether or not DDAVP-stimulated PET imaging demonstrates tumor in MRI-negative cases. This will be demonstrated by assessing the accuracy and sensitivity of FDG high-resolution PET-imaging detection of ACTH-adenomas that could not be reliably detected on MR-imaging.
Secondary Endpoints: Location of tumor on preoperative PET-imaging and location of tumor during surgery. Histopathological confirmation of ACTH-adenoma will be the gold-standard to measure the primary and secondary endpoints.
64 studies on the registry are indexed under Pituitary ACTH Hypersecretion; 16 are open to participants now.
This study's planned enrollment of 22 is below the median of 44 across 40 interventional studies indexed under Pituitary ACTH Hypersecretion.
Browse Pituitary ACTH Hypersecretion studies →National Institute of Neurological Disorders and Stroke (NINDS) is the lead sponsor of 601 studies on the registry; 56 are open to participants now.
Of its 18 completed or terminated interventional studies of FDA-regulated products, 8 (44%) have results posted.
Counted across the registry records on this site, refreshed daily.
In order to be eligible to participate in this study, an individual must meet all of the following criteria:
EXCLUSION CRITERIA:
An individual who meets any of the following criteria will be excluded from participation in this study:
Current use of any of the following medications:
INCLUSION OF VULNERABLE PARTICIPANTS:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Drug: Desmopressin acetate
Intravenous 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
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: Baseline
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: Baseline
Plan to share: Undecided — We will share IPD as required for publications and clinicaltrials.gov registration.
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Pituitary ACTH Hypersecretion →
National Institute of Neurological Disorders and Stroke (NINDS) →