|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Received Date ICMJE | March 2, 2000 | ||||||||
| Last Updated Date | October 3, 2009 | ||||||||
| Start Date ICMJE | February 2000 | ||||||||
| Estimated Primary Completion Date | November 2002 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE | |||||||||
| Original Primary Outcome Measures ICMJE |
Conspicuity of occluded arteries after contrast exposure. | ||||||||
| Change History | Complete list of historical versions of study NCT00004847 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE | |||||||||
| Original Secondary Outcome Measures ICMJE | |||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Diagnosis of Pheochromocytoma | ||||||||
| Official Title ICMJE | Diagnosis, Pathophysiology, and Molecular Biology of Pheochromocytoma and Paraganglioma | ||||||||
| Brief Summary | The goal of this study is to develop better methods of diagnosis 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. Diagnostic tests may include the following:
PLEASE NOTE: Until further notice, we are not offering MIBG131 at this time. |
||||||||
| Detailed Description | Pheochromocytomas are rare but clinically important chromaffin cell tumors that typically arise from the adrenal gland and constitute a surgically correctable cause of chronic hypertension. The clinical features and consequences of pheochromocytoma result from release of catecholamines (e.g., norepinephrine and epinephrine) by the tumor. If a pheochromocytoma is undetected, stimuli that normally would not pose a hazard, such as surgery, childbirth, or general anesthesia, can evoke catecholamine secretion by the tumor, with clinically significant and even catastrophic outcomes. The diagnosis of pheochromocytoma and its localization can be challenging, because measurements of plasma levels or urinary excretion of catecholamines and their metabolites and radio-iodinated metaiodobenzylguanidine (MIBG) scanning can yield false-negative results in patients harboring the tumor. Computed tomographic and magnetic resonance imaging lack sufficient specificity. The molecular mechanisms by which genotypic changes predispose to development of pheochromocytoma remain unknown, even in patients with identified mutations. Moreover, pheochromocytomas in patients with hereditary predispositions differ in terms of their growth, malignant potential, catecholamine phenotype, and responses to standard screening tests such as glucagon stimulation and clonidine suppression tests. This protocol focuses on molecular and genetic studies that elucidate the bases for predisposition to develop pheochromocytomas and for expression of different neurochemical phenotypes and malignant potentials, new imaging approaches, based on [(18)F]-6F-dopamine ([(18)F-6F-DA), and [(18)F]-L-3,4-dihyroxyphenylalanine ([(18)F-DOPA) positron emission tomographic (PET) scanning, [99m]Tc-methoxyisobutylisonitrile SPECT scintigraphy ((99m)Tc-MIBI), and new bicochemical diagnostic criteria, based on measurement of plasma metanephrines. |
||||||||
| Study Phase | |||||||||
| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | |||||||||
| Condition ICMJE | Pheochromocytoma | ||||||||
| Intervention ICMJE | |||||||||
| Study Arms / Comparison Groups | |||||||||
| Publications * |
|
||||||||
|
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
|||||||||
| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Enrollment ICMJE | 1000 | ||||||||
| Completion Date | |||||||||
| Estimated Primary Completion Date | November 2002 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE |
Patients are adults or children with known or suspected sporadic or familial pheochromocytoma/paraganglioma, on the basis of one or more of the following:
Patients must be willing to return to NIH for follow-up evaluation. Patients with pheochromocytoma/paraganglioma will be accepted based on referral from clinicians. EXCLUSION CRITERIA: Imaging studies are not done in pregnant or lactating women. A pregnancy test is performed in women of child-bearing age (up to age 55). In those with positive results, no PET scanning, MIBG scanning, contrast CT, or vena cava sampling is performed. Glucagon and clonidine testing are not performed in pregnant women. Pregnant women who are greater than 26 weeks pregnant are excluded from admission to the Clinical Center, but may be studied as outpatients. Patients with impaired mental capacity that precludes informed consent. |
||||||||
| Gender | Both | ||||||||
| Ages | 7 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
|
||||||||
| Location Countries ICMJE | United States, Netherlands | ||||||||
| Administrative Information | |||||||||
| NCT ID ICMJE | NCT00004847 | ||||||||
| Responsible Party | |||||||||
| Study ID Numbers ICMJE | 000093, 00-CH-0093 | ||||||||
| Study Sponsor ICMJE | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | ||||||||
| Collaborators ICMJE | |||||||||
| Investigators ICMJE | |||||||||
| Information Provided By | National Institutes of Health Clinical Center (CC) | ||||||||
| Verification Date | August 2009 | ||||||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||||||