Cushing's DiseaseNCT04569591
DDAVP for Pituitary Adenoma
A study testing Desmopressin acetate in people with Cushing's Disease and Pituitary Adenoma, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 8 to 99 years
- Conditions the study is for
- Cushing's Disease, Pituitary Adenoma
- What is being tested?
- Desmopressin acetate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Mar 2026to 26 Feb 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 99 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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)
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- 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
- 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.
Who cannot join
- An individual who meets any of the following criteria will be excluded from participation in this study:
- 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.
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- Uncontrolled, severe hypotension (sustained blood pressure <90/60), or symptomatic hypotension.
- 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
- Habitual or psychogenic polydipsia, due to increased risk of hyponatremia
- History of Type IIB von Willebrand s disease due to risk for thrombosis.
- Elevated blood glucose level above 200 mg/dL on the day of the scan prior to FDG administration.
- Known intolerance to DDAVP
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR), 800-411-1222 ext. TTY8664111010, prpl@cc.nih.gov
About this study
Official title: Desmopressin (DDAVP) Stimulation for 18F-FDG-PET Detection of Pituitary Adenoma in Cushing's Disease
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.
Read the detailed description
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.
- Conditions
- Cushing's Disease, Pituitary Adenoma
- Being tested
- Desmopressin acetate
- Keywords
- Corticotropinoma, Pituitary Microadenoma, Acthrel
- Medical subject headings
- Pituitary ACTH Hypersecretion, Pituitary Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Desmopressin acetateDrug
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
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | 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 Receives: Drug: Desmopressin acetate |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline
Secondary 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)
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2020
- Study start9 Mar 2026
- Primary completion26 Feb 2028 (estimated)
- Study completion26 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cushing's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Prashant Chittiboina, M.D., Principal investigator, National Institute of Neurological Disorders and Stroke (NINDS)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04569591
- Sponsor's protocol ID
- 200048
- Other IDs
- 20-N-0048
- Status last verified
- 1 Apr 2026
- First submitted
- 29 Sep 2020
- Last updated
- 9 Apr 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: We will share IPD as required for publications and clinicaltrials.gov registration.
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Desmopressin (DDAVP) Stimulation for 18F-FDG-PET Detection of Pituitary Adenoma in Cushing's Disease
- ClinicalTrials.gov ID
- NCT04569591
- Acronym / sponsor ID
- 200048
- Conditions
- Cushing's Disease, Pituitary Adenoma
- Keywords
- Corticotropinoma, Pituitary Microadenoma, Acthrel
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 22 participants (estimated)
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)US National Institutes of Health
- Study start
- 9 Mar 2026 (actual)
- Primary completion
- 26 Feb 2028 (estimated)
- Study completion
- 26 Feb 2028 (estimated)
- First posted
- 30 Sep 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Desmopressin acetatepatients 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 |
Who may qualify
- Ages
- 8 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (15 listed)
- An individual who meets any of the following criteria will be excluded from participation in this study:
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Desmopressin acetateIntravenous 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 | Drug | 1 |
Primary outcome
The primary outcome measure will be defined as whether or not DDAVP-stimulated PET imaging demonstrates tumor in MRI-negative cases.
Time frame: Baseline
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.
1 secondary outcome
To assess the accuracy of FDG high-resolution PET-imaging localization of ACTH-adenomas in CD compared to surgical and histologic localization.
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2026.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. We will share IPD as required for publications and clinicaltrials.gov registration.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Prashant Chittiboina, M.D. principal investigator
National Institute of Neurological Disorders and Stroke (NINDS)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Desmopressin acetate in people with Cushing's Disease and Pituitary Adenoma, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 9 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Christina P Hayes, C.R.N.P. ((301) 496-2921, christi.hayes@nih.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary outcome measure will be defined as whether or not DDAVP-stimulated PET imaging demonstrates tumor in MRI-negative cases. (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2026.