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NCT00004847 · ClinicalTrials.gov registry record · Phase 1
Diagnosis of Pheochromocytoma
A Phase 1 study of Pheochromocytoma and Endocrine Disease, sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
- Recruiting
- Registry status
- Phase 1
- Development phase
- 3,000
- Enrollment target
- 1
- Study location
NCT00004847 is a Phase 1 study of Pheochromocytoma and Endocrine Disease that is actively recruiting participants, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD). The registered enrollment target is 3,000 participants, above the 306-participant average among 14 other Pheochromocytoma trials with a reported enrollment target (880% higher). The trial reports 1 study location across 1 state.
The verdict
NCT00004847, a Phase 1 study of Pheochromocytoma and Endocrine Disease, is actively recruiting participants, sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 3,000 participants
- Enrollment target
- 1
- Study location
Study Summary
The goal of this study is to develop better methods of diagnosis, localization, and treatment for pheochromocytomas. These tumors, which usually arise from the adrenal glands, are often difficult to detect with current methods. Pheochromocytomas release chemicals called catecholamines, causing high blood pressure. Undetected, the tumors can lead to severe medical consequences, including stroke, heart attack and sudden death, in situations that would normally pose little or no risk, such as surgery, general anesthesia or childbirth. Patients with pheochromocytoma may be eligible for this study. Candidates will be screened with a medical history and physical examination, electrocardiogram, and blood and urine tests. Study participants will undergo blood, urine, and imaging tests, described below, to detect pheochromocytoma. If a tumor is found, the patient will be offered surgery. If surgery is not feasible (for example, if there are multiple tumors that cannot be removed), evaluations will continue in follow-up visits. If the tumor cannot be found, the patient will be offered medical treatment and efforts to detect the tumor will continue. Main diagnostic and research tests may include the following: 1. Blood tests - mainly measurements of plasma or urine catecholamines and metanephrines as well as methoxytyramine. If necessary the clonidine suppression test can be carried out. 2. Standard imaging tests - Non-investigational imaging tests include computed tomography (CT), magnetic resonance imaging (MRI), sonography, and 123I-MIBG scintigraphy and FDG (positron emission tomography) PET/CT. These scans may be done before and/or after surgical removal of pheochromocytoma. 3. Research PET scanning is done using an injection of radioactive compounds. Patients may undergo 18F-FDOPA, 18F-DA, as well as 68Ga-DOTATATE PET/CT . Each scan takes up to about 2 hours. 4. Genetic testing - A small blood sample is collected for DNA analysis and other analyses.
Conditions Studied
Interventions
- DRUG ([18F]-DOPA)
- DRUG ([18F]-6F-DA)
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3,000 participants |
| Start Date | 2000-03-22 |
| Est. Completion | 2048-11-30 |
| Phase | Phase 1 |
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 NCT00004847
The ClinicalTrials.gov registry entry for NCT00004847 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 3,000 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 306-participant average among 14 other Pheochromocytoma trials with a reported enrollment target (880% higher). 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 3 conditions, with Pheochromocytoma appearing as the primary indexed condition, and to 2 interventions - of which ([18F]-DOPA) is the first listed.
NCT00004847 reports 1 study location spanning 1 distinct geographic area - top geographies include Maryland.
Frequently Asked Questions
What is clinical trial NCT00004847 about?
NCT00004847 is a clinical study titled "Diagnosis of Pheochromocytoma". The goal of this study is to develop better methods of diagnosis, localization, and treatment for pheochromocytomas. These tumors, which usually arise from the adrenal glands, are often difficult to detect with current methods. Pheochromocytomas release chemicals called catecholamines, causing high ...
What is the current status of trial NCT00004847?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 3,000 participants. The study started on 2000-03-22. Estimated completion is 2048-11-30.
What conditions does trial NCT00004847 study?
This clinical trial studies the following conditions: Pheochromocytoma, Endocrine Disease, Endocrine Diseases.
What interventions are being tested in trial NCT00004847?
The interventions under investigation include: ([18F]-DOPA) (DRUG), ([18F]-6F-DA) (DRUG).
Who is sponsoring clinical trial NCT00004847?
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 NCT00004847 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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