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Home > "D" Clinical Trials Conditions > Diagnosis of Pheochromocytoma  Diagnosis of Pheochromocytoma
Diagnosis of Pheochromocytoma
For Condition: Pheochromocytoma
Status: Recruiting
Sponsor(s): National Institute of Child Health and Human Development (NICHD) ,
Synopsis: 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: 1. Blood tests - Two blood tests-glucagon stimulation and clonidine suppression-are done that require insertion of intravenous (i.v.) catheters (thin flexible tubes) into arm veins. While the patient rests lying down, a drug (glucagon or clonidine) is given through the i.v. line. Blood pressure and heart rate are monitored frequently, and blood is collected from the i.v. line to measure levels of catecholamines and their breakdown products, metanephrines. 2. Regional venous sampling - Selective vena caval sampling may be required for some patients. A catheter is placed into a large blood vessel called the inferior vena cava, through which blood circulating in the body returns to the heart. Blood samples are collected for measurement of catecholamines and metanephrines. 3. Standard imaging tests - Non-investigational imaging tests include computed tomography (CT), magnetic resonance imaging (MRI), sonography, and 131I-MIBG scanning. These scans may be done before and after surgical removal of pheochromocytoma. 4. PET imaging - Positron emission tomography (PET) scanning is done using an injection of a radioactive catecholamine called fluorodopamine. The fluorodopamine enters pheochromocytoma cells, making the tumor radioactive and visible on the PET scan. The scan takes up to about 2 hours. 5. Urine - A 24-hour urine collection is collected for analysis. 6. Genetic testing - A small blood sample is collected for DNA analysis.
Details: 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 6-[18F]fluorodopamine ([18F]-6F-DA) positron emission tomographic (PET) scanning, and new biochemical diagnostic criteria, based on measurement of plasma metanephrines.
Eligibility:
Study Type: Observational, Natural History
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: INCLUSION CRITERIA: Patients are adults or children with known or suspected sporadic or familial pheochromocytoma, on the basis of one or more of the following: (a) new onset of hypertension or hypertensive episodes and symptoms suggestive of pheochromocytoma (sweating, headache, pallor, palpitations); or (b) high levels of blood or urinary catecholamines or metanephrines. Both male and female subjects of all ethnic and racial groups are eligible. Patients must be willing to return to NIH for follow up evaluation. Patients with pheochromocytoma 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. Pregnant women who are greater than 26 weeks pregnant are excluded from admission to the Clinical Center, but may be studied as outpatients. [18F]-6F-DA PET scanning is not done in children. Patients with impaired mental capacity that precludes informed consent.
Total Enrollment: 280
Location and Contact Information:
National Institute of Child Health and Human Development (NICHD) *Recruiting*
Bethesda, Maryland, 20892
United States
Recruiting Patient and Public Liaison Office 1-800-411-1222
Additional Information:
Study ID Numbers: 000093; 00-CH-0093
Study Start Date: February 29, 2000
Record last reviewed: November 20, 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004847
Other Pheochromocytoma Studies:
1. Blood Sampling for Neurochemical and Genetic Testing
2. Catecholamine Release in Pseudopheochromocytoma
3. Diagnosis and Treatment of Pheochromocytoma
4. Surgery With or Without Chemotherapy in Treating Patients With Soft Tissue Sarcoma
5. 131MIBG to Treat Malignant Pheochromocytoma
Related Studies:
Other Pheochromocytoma Clinical Trials
Other Maryland Clinical Trials
Other Bethesda Clinical Trials
Diagnosis of Pheochromocytoma
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