CRH Stimulation for Cushing's Disease

Overseen By Prashant Chittiboina, M.D.

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: National Institute of Neurological Disorders and Stroke (NINDS)

Disqualifiers: Pregnancy, Renal insufficiency, High glucose, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

22 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

How does CRH stimulation differ from other treatments for Cushing's Disease?

CRH stimulation is unique because it involves using corticotropin-releasing hormone to assess and enhance the body's response to ACTH and cortisol, which are hormones involved in stress response. This approach is different from other treatments that may focus on directly reducing cortisol levels or surgically removing the source of excess hormone production. ^{1 2 3 4 5}

Research Team

Prashant Chittiboina, M.D.

Principal Investigator

National Institute of Neurological Disorders and Stroke (NINDS)

Eligibility Criteria

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.

Inclusion Criteria

Ability to provide informed consent for study participation (parents or guardians in the case of minors)

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.

Exclusion 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 have severe kidney issues or had a liver transplant.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

CRH Stimulation and PET Imaging

Participants receive CRH stimulation followed by 18F-FDG PET imaging to detect MRI-negative pituitary adenomas

1 day

1 visit (in-person)

Surgery

Participants undergo surgical resection of the pituitary adenoma within 12 weeks after PET imaging

Within 12 weeks

Follow-up

Participants continue regular follow-up in the clinic to monitor recovery and treatment effectiveness

Ongoing

Treatment Details

Interventions

• Acthrel

Trial Overview 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.

Participant Groups

Group I: 1 Experimental Treatment 1 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

Who Is Running the Clinical Trial?

National Institute of Neurological Disorders and Stroke (NINDS)

Lead Sponsor

Trials

1,403

Recruited

655,000+

References

1. England pubmed.ncbi.nlm.nih.gov

Sensitivity of Different ACTH and Cortisol Concentration Values in Corticotropin-Releasing Hormone Based Tests in Cushing's Disease. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Paradoxical Results after Inadvertent Use of Cosyntropin [Adrenocorticotropin Hormone (1-24)] Rather than Acthrel (Ovine Corticotropin Releasing Hormone) during Inferior Petrosal Sinus Sampling. [2021]

3. England pubmed.ncbi.nlm.nih.gov

ACTH after 15 min distinguishes between Cushing's disease and ectopic Cushing's syndrome: a proposal for a short and simple CRH test. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

The effect of pulsatile human corticotropin-releasing hormone administration on the adrenal insufficiency that follows cure of Cushing's disease. [2015]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Combined Administration of Ghrelin and Corticotropin-Releasing Hormone in the Diagnosis of Cushing's Disease. [2017]