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|NCT01459237 : Effects of Hormone Stimulation on Brain Scans for Cushing s Disease|
|Phase||Early Phase 1|
|Ages||Min: 8 Years Max: N/A|
- INCLUSION CRITERIA:
To be eligible for entry into the study, patients must meet all the following criteria:
1. Be 8 years of age or older and able to undergo PET-imaging without needing general
2. Able to provide informed consent (or guardian is able to provide consent in case of
3. Clinical diagnosis of CD based on medical records.
4. Medically able to undergo resection of pituitary adenoma and planning to undergo
surgical resection of adenoma within 12 weeks of PET-imaging.
5. 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.
Candidates will be excluded if they meet any of the following criteria:
1. Pregnant or nursing women.
2. 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
3. Severe chronic renal insufficiency (glomerular filtration rate < 30 mL/min/1.73
m(2)), hepatorenal syndrome or post-liver transplantation.
4. Elevated blood glucose level above 200 mg/dL on the day of the scan prior to
5. Known intolerance to CRH.
|Links||Permanent Link to THIS page: https://virtualtrials.com/nct/display1trial.cfm?nct=NCT01459237
| Link to official Clinicaltrials.gov listing