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CRH Stimulation for Cushing's Disease
N/A
Waitlist Available
Led By Prashant Chittiboina, M.D.
Research Sponsored by National Institute of Neurological Disorders and Stroke (NINDS)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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)
Surgical candidate for resection of ACTH producing pituitary adenoma within 1 weeks of PET-imaging
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline
Awards & highlights
Study Summary
This trial is testing whether giving the hormone CRH before a PET scan can help make pituitary gland tumors more visible.
Who is the study for?
This trial is for people aged 8 or older with Cushing's disease from a pituitary tumor, which isn't clearly visible on MRI. They must be able to have a PET scan without anesthesia and give consent (parents/guardians for minors). Candidates should be ready for surgery within three months after the scan and have normal liver function.Check my eligibility
What is being tested?
The study tests if CRH hormone given before a PET brain scan can better detect pituitary tumors in Cushing's disease patients. Participants will receive an injection of radioactive sugar and CRH, followed by imaging inside a scanner.See study design
What are the potential side effects?
Potential side effects may include discomfort from needle insertion, reactions to the CRH hormone such as flushing or palpitations, and exposure to radiation from the radioactive sugar used during the PET scan.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 8 or older with Cushing's disease and my MRI might show a tumor in the pituitary gland.
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I am scheduled for surgery to remove a tumor in my pituitary gland within 1 week after a PET scan.
Select...
My liver function tests are within normal limits.
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I can have a PET scan without needing to be put to sleep.
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I have been diagnosed with Cushing's disease.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
CRH-stimulated PET imaging demonstrates tumor in MRI-negative cases.
Secondary outcome measures
Elevation of SUV of 18F-FDG
Trial Design
1Treatment groups
Experimental Treatment
Group I: 1Experimental Treatment1 Intervention
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
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Acthrel
2009
N/A
~20
Find a Location
Who is running the clinical trial?
National Institute of Neurological Disorders and Stroke (NINDS)Lead Sponsor
1,341 Previous Clinical Trials
650,070 Total Patients Enrolled
1 Trials studying Cushing's Disease
22 Patients Enrolled for Cushing's Disease
Prashant Chittiboina, M.D.Principal InvestigatorNational Institute of Neurological Disorders and Stroke (NINDS)
6 Previous Clinical Trials
648 Total Patients Enrolled
1 Trials studying Cushing's Disease
22 Patients Enrolled for Cushing's Disease
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a known intolerance to CRH.Your blood sugar level is higher than 200 mg/dL before the scan with 18F-FDG.I am 8 or older with Cushing's disease and my MRI might show a tumor in the pituitary gland.I am scheduled for surgery to remove a tumor in my pituitary gland within 1 week after a PET scan.My liver function tests are within normal limits.I can have a PET scan without needing to be put to sleep.I have been diagnosed with Cushing's disease.I have severe kidney issues or had a liver transplant.I've had a detailed brain scan within the last 9 months.
Research Study Groups:
This trial has the following groups:- Group 1: 1
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is the recruitment of participants still active for this research?
"Unfortunately, this trial is no longer actively searching for patients. It was posted on December 7th 2022 and had a final update on the 1st of that month. However, if you are seeking alternative studies there are 94 active clinical trials for Cushing's disease and 2 admitting patients for Acthrel treatment."
Answered by AI
How many subjects have been enrolled in this investigation?
"This medical trial is not presently seeking candidates. It was initially posted on December 7th, 2022 and had its most recent update a month later. If interested in alternative studies, there are 94 studies currently looking for patients with Cushing's Disease and two trials accepting participants for Acthrel treatment."
Answered by AI
Are there any prior precedents for using Acthrel in a medical experiment?
"Currently, two trials are underway to evaluate the efficacy of Acthrel. None have reached phase 3 yet but there are sites in Bethesda, Maryland and another location actively conducting these tests."
Answered by AI
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