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New treatment option for Cushing's Disease
Official title DDAVP for Pituitary Adenoma
ClinicalTrials.gov ID: NCT04569591
What this study is testing
What is Desmopressin acetate?
Desmopressin acetate is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for cushing's disease.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- This is a blinded study.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 8 to 99
You may be able to join if
- In order to be eligible to participate in this study, an individual must meet all of the following criteria:
- people aged 8 or older with biochemical evidence of Cushing s disease and a clinical MRI pituitary neuroradiology result of negative or possible...
- 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
You likely can't join if
- 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...
- Uncontrolled hypertension (blood pressure \>150/95 mmHg) due to risk of further increase if fluid overload occurs.
See the full eligibility criteria
- In order to be eligible to participate in this study, an individual must meet all of the following criteria:
- people 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
- 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
- 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.
- 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...
- 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 INCLUSION OF VULNERABLE PARTICIPANTS:
- Children: Children age 8 and older are included in this protocol. More than half of the people with CD requiring transsphenoidal surgery at the NIH are children. The knowledge gained by the use of DDAVP PET imaging in...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Bethesda, Maryland, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 8 years to 99 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bethesda, Maryland, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.