- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04569591
Corticotrophin-releasing Hormone (CRH) Stimulation for 18F-FDG-PET Detection of Pituitary Adenoma in Cushing s Disease
Corticotrophin-Releasing Hormone (CRH) Stimulation for 18F-FDG-PET Detection of Pituitary Adenoma in Cushing's Disease
Background:
Cushing s disease is caused by a pituitary gland tumor. Patients with Cushing s disease suffer obesity, diabetes, osteoporosis, weakness, and hypertension. The cure is surgery to remove the pituitary tumor. Currently, MRI is the best way to find these tumors. But not all tumors can be seen with an MRI. Researchers hope giving the hormone CRH before a PET scan can help make these tumors more visible.
Objective:
To test whether giving CRH before a PET scan will help find pituitary gland tumors that might be causing Cushing s disease.
Eligibility:
People ages 8 and older with Cushing s disease that is caused by a pituitary gland tumor that cannot be reliably seen on MRI
Design:
Participants will be screened with their medical history, a physical exam, an MRI, and blood tests.
Participants will have at least one hospital visit. During their time in the hospital, they will have a physical exam and a neurological exam. They will have a PET scan of the brain. A thin plastic tube will be inserted into an arm vein. A small amount of radioactive sugar and CRH will be injected through the tube. Participants will lie in a darkened room for about an hour and be asked to urinate. Then they will lie inside the scanner for about 40 minutes. After the scan, they will be asked to urinate every 2-3 hours for the rest of the day. Blood will be drawn through a needle in the arm.
Participants will have surgery to remove their tumor within 3 months after the scan.
Participants will then continue regular follow-up in the clinic.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Prashant Chittiboina, M.D.
- Phone Number: (301) 496-2921
- Email: prashant.chittiboina@nih.gov
Study Contact Backup
- Name: Isaac J Pomeraniec, M.D.
- Phone Number: (301) 496-2921
- Email: jonathan.pomeraniec@nih.gov
Study Locations
-
-
Maryland
-
Bethesda, Maryland, United States, 20892
- National Institutes of Health Clinical Center
-
Contact:
- For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)
- Phone Number: TTY8664111010 800-411-1222
- Email: prpl@cc.nih.gov
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
- INCLUSION CRITERIA:
In order to be eligible to participate in this study, an individual must meet all of the following criteria:
- Patients 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' around)
- MRI of the Pituitary gland with and without contrast obtained within 9 months of screening
- 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 resection of ACTH producing pituitary adenoma within 1 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
- Enrolled in 03-N-0164, Evaluation of Neurosurgical Disorders.
EXCLUSION CRITERIA:
An individual who meets any of the following criteria will be excluded from participation in this study:
- Pregnancy or lactation
- Severe chronic renal insufficiency (glomerular filtration rate < 30 mL/min/1.73 m squared), hepatorenal syndrome or post-liver transplantation.
- Elevated blood glucose level above 200 mg/dL on the day of the scan prior to 18F-FDG administration.
- Known intolerance to CRH
INCLUSION OF VULNERABLE PARTICIPANTS:
- Children: Children age 8 and older are included in this protocol. More than half of the patients with CD requiring transsphenoidal surgery at the NIH are children. Furthermore, the knowledge gained by the use of CRH PET imaging in children with MR-invisible tumors will provide direct benefit to the individual child and will provide generalizable knowledge in the treatment of CD in this population. Children under the age of 8 usually require anesthesia for a PET scan, which involves greater risk. Therefore, children under the age of 8 will be excluded from participation.
NIH Employees: Protections for employees and staff participating in this study include:
1) assuring that the participation or refusal to participate will have no effect, either beneficial or adverse, on the subject s employment or position at the NIH, 2) giving employees and staff who are interested in participating the 'NIH Information Sheet on Employee Research Participation' prior to obtaining consent, and 3) assuring that there will be no direct solicitation of employees or staff. 4) Independent consent monitoring will be provided by the NIH HSPU. 5) The PI will train study staff regarding obtaining and handling potentially sensitive and private information about co-workers through staff discussions and written branch/section procedures. No compensation will be provided for this protocol.
- 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 pregnant will have a pregnancy test performed within 24 hours before PET-imaging. Individuals will not be able to participate in PET scanning if the pregnancy test results positive.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
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
|
Intravenous administration of ovine CRH (Acthrel (Registered Trademark) 1 mcg/kg up to a maximum dose of 100 mcg) results in selective increase in ACTH activity of pituitary adenomas within two minutes and peaks between 10-15 minutes.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
CRH-stimulated PET imaging demonstrates tumor in MRI-negative cases.
Time Frame: Baseline
|
The primary outcome measure will be defined as whether or not CRH- stimulated PET imaging demonstrates 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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Elevation of SUV of 18F-FDG
Time Frame: Baseline
|
To measure the elevation of SUV of 18F-FDG within adenomas compared to surrounding normal gland following CRH stimulated PET imaging.
|
Baseline
|
Collaborators and Investigators
Investigators
- Principal Investigator: Prashant Chittiboina, M.D., National Institute of Neurological Disorders and Stroke (NINDS)
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Neoplasms by Site
- Neoplasms, Glandular and Epithelial
- Endocrine System Diseases
- Endocrine Gland Neoplasms
- Hypothalamic Diseases
- Hypothalamic Neoplasms
- Supratentorial Neoplasms
- Brain Neoplasms
- Central Nervous System Neoplasms
- Nervous System Neoplasms
- Hyperpituitarism
- Adenoma
- Pituitary Neoplasms
- Pituitary Diseases
- ACTH-Secreting Pituitary Adenoma
- Pituitary ACTH Hypersecretion
Other Study ID Numbers
- 200048
- 20-N-0048
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Pituitary Adenoma
-
Asan Medical CenterUnknownPituitary ACTH Secreting AdenomaKorea, Republic of
-
Tiburio TherapeuticsNot yet recruitingNon-Functional Pituitary Adenoma | Pituitary Tumor, Nonfunctioning
-
Zhaoyun ZhangUnknownPituitary TumorChina
-
University of CopenhagenOdense University Hospital; Aarhus University Hospital; Rigshospitalet, Denmark; Aalborg University Hospital and other collaboratorsCompletedAcromegaly Due to Pituitary AdenomaDenmark
-
Samsung Medical CenterNot yet recruitingAcromegaly Due to Pituitary AdenomaKorea, Republic of
-
Vastra Gotaland RegionRecruitingNon-functioning Pituitary AdenomaSweden
-
Asan Medical CenterUnknownCavernous Sinus Invasion by Pituitary AdenomaKorea, Republic of
-
Zealand University HospitalNot yet recruitingNon-Functional Pituitary Adenoma
-
Novartis PharmaceuticalsCompleted
-
University of Sao Paulo General HospitalCompletedPituitary Adenoma | Nonfunctioning Pituitary AdenomaBrazil
Clinical Trials on Acthrel
-
National Institute of Neurological Disorders and...CompletedPituitary NeoplasmUnited States
-
Medical University of South CarolinaCompleted
-
Children's Mercy Hospital Kansas CityWithdrawnFunctional DyspepsiaUnited States
-
University of MichiganCompletedStressUnited States
-
Lundquist Institute for Biomedical Innovation at...Active, not recruiting
-
Lundquist Institute for Biomedical Innovation at...Active, not recruitingSleep RestrictionUnited States