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NCT00001849 · ClinicalTrials.gov registry record · Phase 2
New Imaging Techniques in the Evaluation of Patients With Ectopic Cushing Syndrome
A Phase 2 study of Cushing Syndrome and Endocrine Disease, sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
- Completed
- Registry status
- Phase 2
- Development phase
- 95
- Enrollment target
- 1
- Study location
NCT00001849 is a Phase 2 study of Cushing Syndrome and Endocrine Disease that has completed, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD). The registered enrollment target is 95 participants, below the 170-participant average among 9 other Cushing Syndrome trials with a reported enrollment target (44% lower). The trial reports 1 study location across 1 state.
The verdict
NCT00001849, a Phase 2 study of Cushing Syndrome and Endocrine Disease, has completed, sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 95 participants
- Enrollment target
- 1
- Study location
Study Summary
Cushing Syndrome is an endocrine disorder causing an over production of the hormone cortisol. Cortisol is produced in the adrenal gland as a response to the production of corticotropin (ACTH) in the pituitary gland. Between 10% and 20% of patients with hypercortisolism (Cushing Syndrome) have ectopic production of the hormone ACTH. Meaning, the hormone is not being released from the normal site, the pituitary gland. In many cases the ectopic ACTH is being produced by a tumor of the lung, thymus, or pancreas. However, in approximately 50% of these patients the source of the ACTH cannot be found even with the use of extensive imaging studies such as computed tomography (CT) scans, magnetic resonance imaging (MRI), and nuclear scans (111-indium pentetreotide). The ability of these tests to locate the source of the hormone production is dependent on the changes of anatomy and / or the dose and adequate uptake of the radioactive agent. The inability to detect the source of ectopic ACTH production often results in unnecessary pituitary surgery or irradiation. Unlike the previously described tests, positron emission tomography (PET scan) has the ability to detect pathologic tissue based on physiologic and biochemical processes within the abnormal tissue. This study will test whether fluorine-18-fluorodeoxyglucose (FDG), fluorine-18-dihydroxyphenylalanine (F-DOPA) or use of a higher dose of 111-indium pentetreotide can be used to successfully localize the source of ectopic ACTH production.
Conditions Studied
Interventions
- DEVICE MRI
- DRUG 18F-DOPA
- DRUG Pentetreotide
- DEVICE CT scan
- DRUG 18-FDG
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center, 9000 Rockville Pike - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 95 participants |
| Start Date | 1999-05-20 |
| Est. Completion | 2019-04-26 |
| Phase | Phase 2 |
Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)305 total trials
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00001849
The ClinicalTrials.gov registry entry for NCT00001849 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 95 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 170-participant average among 9 other Cushing Syndrome trials with a reported enrollment target (44% lower). The listed sponsor is Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), which has 305 total studies on file at ClinicalTrials.gov.
The record links to 2 conditions, with Cushing Syndrome appearing as the primary indexed condition, and to 5 interventions - of which MRI is the first listed.
NCT00001849 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.
Frequently Asked Questions
What is clinical trial NCT00001849 about?
NCT00001849 is a clinical study titled "New Imaging Techniques in the Evaluation of Patients With Ectopic Cushing Syndrome". Cushing Syndrome is an endocrine disorder causing an over production of the hormone cortisol. Cortisol is produced in the adrenal gland as a response to the production of corticotropin (ACTH) in the pituitary gland. Between 10% and 20% of patients with hypercortisolism (Cushing Syndrome) have ectop...
What is the current status of trial NCT00001849?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 95 participants. The study started on 1999-05-20. Estimated completion is 2019-04-26.
What conditions does trial NCT00001849 study?
This clinical trial studies the following conditions: Cushing Syndrome, Endocrine Disease.
What interventions are being tested in trial NCT00001849?
The interventions under investigation include: MRI (DEVICE), 18F-DOPA (DRUG), Pentetreotide (DRUG), CT scan (DEVICE), 18-FDG (DRUG).
Who is sponsoring clinical trial NCT00001849?
This trial is sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), which has 305 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00001849 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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Related
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