Status:
COMPLETED
Effects of Hormone Stimulation on Brain Scans for Cushing s Disease
Lead Sponsor:
National Institute of Neurological Disorders and Stroke (NINDS)
Conditions:
Pituitary Neoplasm
Eligibility:
All Genders
8+ years
Phase:
EARLY_PHASE1
Brief Summary
Background: * Cushing s disease can be caused by a tumor of the pituitary gland, a small gland about the size of a pea located at the base of the brain. These tumors produce high levels of hormones, ...
Detailed Description
Objective Preoperative imaging identification and localization of adrenocorticotropin hormone (ACTH)-secreting pituitary adenomas is critical for the accurate diagnosis and the successful surgical tr...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- To be eligible for entry into the study, patients must meet all the following criteria:
- Be 8 years of age or older and able to undergo PET-imaging without needing general anesthesia.
- Able to provide informed consent (or guardian is able to provide consent in case of minor).
- Clinical diagnosis of CD based on medical records.
- Medically able to undergo resection of pituitary adenoma and planning to undergo surgical resection of adenoma within 12 weeks of PET-imaging.
- Normal liver enzymes: tests should be completed within 14 days before injection of the radiopharmaceutical; SGOT, SGPT less than or equal to 5 times ULN; bilirubin less than or equal to 2 times ULN.
- EXCLUSION CRITERIA:
- Candidates will be excluded if they meet any of the following criteria:
- Pregnant or nursing women.
- Contraindication to MR-scanning, including pacemakers or other implanted electrical devices, brain stimulators, some types of dental implants, aneurysm clips (metal clips on the wall of a large artery), metallic prostheses (including metal pins and rods, heart valves, and cochlear implants), permanent eyeliner, implanted delivery pump, or shrapnel fragments
- Severe chronic renal insufficiency (glomerular filtration rate \< 30 mL/min/1.73 m(2)), hepatorenal syndrome or post-liver transplantation.
- Elevated blood glucose level above 200 mg/dL on the day of the scan prior to (18)F-FDG administration.
- Known intolerance to CRH.
Exclusion
Key Trial Info
Start Date :
October 11 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 12 2018
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT01459237
Start Date
October 11 2011
End Date
June 12 2018
Last Update
June 14 2018
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892