DDAVP for Pituitary Adenoma

NCT04569591 | Recruiting

• 2 other identifiers: 20004820-N-0048
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Pituitary Adenoma; Cushing's Disease

Keywords

Corticotropinoma; Pituitary Microadenoma; Acthrel

Outcome Measures

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.

  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.

  Baseline

Study Arms (1)

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

Drug: Desmopressin acetate

Interventions

Desmopressin acetate DRUG

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

1

Eligibility Criteria

• Age: 8 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• 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

You may not qualify 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 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, 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

Sponsors & Collaborators

• National Institute of Neurological Disorders and Stroke (NINDS): lead

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

RECRUITING

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Pituitary ACTH Hypersecretion; Pituitary Neoplasms

Interventions

Deamino Arginine Vasopressin

Condition Hierarchy (Ancestors)

Hyperpituitarism; Pituitary Diseases; Hypothalamic Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Endocrine System Diseases; Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Hypothalamic Neoplasms; Supratentorial Neoplasms; Brain Neoplasms; Central Nervous System Neoplasms; Nervous System Neoplasms

Intervention Hierarchy (Ancestors)

Arginine Vasopressin; Vasopressins; Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins

Study Officials

• Prashant Chittiboina, M.D.

  National Institute of Neurological Disorders and Stroke (NINDS)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christina P Hayes, C.R.N.P.

CONTACT

(301) 496-2921; christi.hayes@nih.gov

Prashant Chittiboina, M.D.

CONTACT

(301) 496-2921; prashant.chittiboina@nih.gov

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 29, 2020
• First Posted: September 30, 2020
• Study Start: March 9, 2026
• Primary Completion (Estimated): February 26, 2028
• Study Completion (Estimated): February 26, 2028
• Last Updated: April 9, 2026

Record last verified: 2026-04-01

Locations

US (1)