Effects of Hormone Stimulation on Brain Scans for Cushing s Disease

NCT01459237 | Completed Early Phase 1

• 2 other identifiers: 12000712-N-0007
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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, which cause obesity, diabetes, and growth problems. The cure for this type of Cushing s disease is to have surgery that removes the tumor but leaves the pituitary gland alone. Currently, magnetic resonance imaging scans are the best way to find these tumors. However, many of these tumors do not show up on the scan.
• Positron emission tomography (PET) scans use radioactive chemicals to light up parts of the body that are more active, such as tumors. Researchers want to try to make the small Cushing s disease tumors more active to help them show up on the scans. A special hormone will be given before the scan to make the tumors more active. Objectives: \- To test the use of hormone stimulation to improve brain scans for Cushing s disease tumors. Eligibility: \- Individuals at least 8 years of age who will be having surgery to remove Cushing s disease tumors. Design:
• Participants will be screened with a medical history, physical exam, blood and urine tests, and imaging studies.
• They will have three brain scans before surgery. The first scan is a magnetic resonance imaging scan to show a full picture of the brain. The second and third scans are PET scans.
• The first PET scan will be given without the special hormone. The second PET scan will be done more than 24 hours but less than 14 days after the first PET scan. The second PET scan will be given with the special hormone.
• Participants will have tumor removal surgery through another study protocol.

Conditions

Pituitary Neoplasm

Keywords

Cushing's Disease; Microadenoma; PET Imaging; Cushing Disease Tumor; Pituitary Tumors

Outcome Measures

Primary Outcomes (1)

• To determine effect of CRH stimulation on 18F-FDG uptake in high-resolution PET-imaging of ACTH-adenomas in CD.

  Ongoing

Secondary Outcomes (2)

• To determine if CRH stimulation (compared to without CRH stimulation) enhances the detection of ACTH-adenomas as demonstrated on 18F-FDG high-resolution PET-imaging in CD.

  Ongoing

• To assess the accuracy and sensitivity of 18F-FDG high-resolution PET-imaging detection of ACTH-adenomas in CD compared to MR-imaging.

  Ongoing

Interventions

Acthrel DRUG

Ovine Corticorelin

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (5)

• Alzahrani AS, Farhat R, Al-Arifi A, Al-Kahtani N, Kanaan I, Abouzied M. The diagnostic value of fused positron emission tomography/computed tomography in the localization of adrenocorticotropin-secreting pituitary adenoma in Cushing's disease. Pituitary. 2009;12(4):309-14. doi: 10.1007/s11102-009-0180-4. Epub 2009 Apr 22.

  PMID: 19387839 BACKGROUND

• Arnaldi G, Angeli A, Atkinson AB, Bertagna X, Cavagnini F, Chrousos GP, Fava GA, Findling JW, Gaillard RC, Grossman AB, Kola B, Lacroix A, Mancini T, Mantero F, Newell-Price J, Nieman LK, Sonino N, Vance ML, Giustina A, Boscaro M. Diagnosis and complications of Cushing's syndrome: a consensus statement. J Clin Endocrinol Metab. 2003 Dec;88(12):5593-602. doi: 10.1210/jc.2003-030871.

  PMID: 14671138 BACKGROUND

• Batista D, Gennari M, Riar J, Chang R, Keil MF, Oldfield EH, Stratakis CA. An assessment of petrosal sinus sampling for localization of pituitary microadenomas in children with Cushing disease. J Clin Endocrinol Metab. 2006 Jan;91(1):221-4. doi: 10.1210/jc.2005-1096. Epub 2005 Oct 11.

  PMID: 16219718 BACKGROUND

• Boyle J, Patronas NJ, Smirniotopoulos J, Herscovitch P, Dieckman W, Millo C, Maric D, Chatain GP, Hayes CP, Benzo S, Scott G, Edwards N, Ray Chaudhury A, Lodish MB, Sharma S, Nieman LK, Stratakis CA, Lonser RR, Chittiboina P. CRH stimulation improves 18F-FDG-PET detection of pituitary adenomas in Cushing's disease. Endocrine. 2019 Jul;65(1):155-165. doi: 10.1007/s12020-019-01944-7. Epub 2019 May 6.

  PMID: 31062234 DERIVED

• Chittiboina P, Montgomery BK, Millo C, Herscovitch P, Lonser RR. High-resolution(18)F-fluorodeoxyglucose positron emission tomography and magnetic resonance imaging for pituitary adenoma detection in Cushing disease. J Neurosurg. 2015 Apr;122(4):791-7. doi: 10.3171/2014.10.JNS14911. Epub 2014 Dec 5.

  PMID: 25479121 DERIVED

MeSH Terms

Conditions

Pituitary Neoplasms; Pituitary ACTH Hypersecretion

Interventions

corticorelin ovine

Condition Hierarchy (Ancestors)

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

Study Officials

• Prashant Chittiboina, M.D.

  National Institute of Neurological Disorders and Stroke (NINDS)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 21, 2011
• First Posted: October 25, 2011
• Study Start: October 11, 2011
• Primary Completion: January 30, 2018
• Study Completion: June 12, 2018
• Last Updated: June 14, 2018

Record last verified: 2018-06-12

Locations

US (1)