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NCT01459237 · ClinicalTrials.gov registry record · Early Phase 1
Effects of Hormone Stimulation on Brain Scans for Cushing s Disease
A Early Phase 1 study of Pituitary Neoplasm, sponsored by National Institute of Neurological Disorders and Stroke (NINDS).
- Completed
- Registry status
- Early Phase 1
- Development phase
- 30
- Enrollment target
- 1
- Study location
NCT01459237 is a Early Phase 1 study of Pituitary Neoplasm that has completed, run by National Institute of Neurological Disorders and Stroke (NINDS). The registered enrollment target is 30 participants. The trial reports 1 study location across 1 state.
The verdict
NCT01459237, a Early Phase 1 study of Pituitary Neoplasm, has completed, sponsored by National Institute of Neurological Disorders and Stroke (NINDS).
- COMPLETED
- Registry status
- Early Phase 1
- Development phase
- 30 participants
- Enrollment target
- 1
- Study location
Study 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 Studied
Interventions
- DRUG Acthrel
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center, 9000 Rockville Pike - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2011-10-11 |
| Est. Completion | 2018-06-12 |
| Phase | Early Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01459237
The ClinicalTrials.gov registry entry for NCT01459237 describes a study currently listed as completed, categorized as Early Phase 1. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Neurological Disorders and Stroke (NINDS), which has 567 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Pituitary Neoplasm appearing as the primary indexed condition, and to 1 intervention - of which Acthrel is the first listed.
NCT01459237 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.
Frequently Asked Questions
What is clinical trial NCT01459237 about?
NCT01459237 is a clinical study titled "Effects of Hormone Stimulation on Brain Scans for Cushing s Disease". 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 t...
What is the current status of trial NCT01459237?
This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 30 participants. The study started on 2011-10-11. Estimated completion is 2018-06-12.
What conditions does trial NCT01459237 study?
This clinical trial studies the following conditions: Pituitary Neoplasm.
What interventions are being tested in trial NCT01459237?
The interventions under investigation include: Acthrel (DRUG).
Who is sponsoring clinical trial NCT01459237?
This trial is sponsored by National Institute of Neurological Disorders and Stroke (NINDS), which has 567 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01459237 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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