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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

Must not have

Severe chronic renal insufficiency (glomerular filtration rate < 30 mL/min/1.73 m squared), hepatorenal syndrome or post-liver transplantation

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline

Awards & highlights

No Placebo-Only Group

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.

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.

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 below

Select...

I am 8 or older with Cushing's disease and my MRI might show a tumor in the pituitary gland.

Select...

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.

Select...

I have been diagnosed with Cushing's disease.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have severe kidney issues or had a liver transplant.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

CRH-stimulated PET imaging demonstrates tumor in MRI-negative cases.

Secondary study objectives

Elevation of SUV of 18F-FDG

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

0 / 6Eligibility criteria met