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Diagnosis and Treatment of Pheochromocytoma

Primary Purpose

Pheochromocytoma

Status
Completed
Phase
Locations
United States
Study Type
Observational
Intervention
Sponsored by
National Heart, Lung, and Blood Institute (NHLBI)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an observational trial for Pheochromocytoma focused on measuring Calcium-Pentagastrin, Clonidine, Glucagon, Pheochromocytoma

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Patients of any age and either sex who are suspected of having a pheochromocytoma on the basis of one or more of the following: 1. hypertensive episodes in a normotensive subject, 2. abnormal levels of blood and/or urinary catecholamines or their metabolites, or 3. an otherwise unexplained abdominal mass. Patients without any evidence of pheochromocytoma are excluded.

Sites / Locations

  • National Heart, Lung and Blood Institute (NHLBI)

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 3, 1999
Last Updated
March 3, 2008
Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
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1. Study Identification

Unique Protocol Identification Number
NCT00001229
Brief Title
Diagnosis and Treatment of Pheochromocytoma
Official Title
Diagnosis and Treatment of Pheochromocytoma
Study Type
Observational

2. Study Status

Record Verification Date
November 1999
Overall Recruitment Status
Completed
Study Start Date
October 1988 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
January 2001 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
National Heart, Lung, and Blood Institute (NHLBI)

4. Oversight

5. Study Description

Brief Summary
Pheochromocytoma is a tumor of the adrenal gland. This tumor is typically benign (not cancerous) and can be cured by surgical removal. However, pheochromocytomas produce neurohormones called cateholamines (epinephrine and norepinephrine). High levels of catecholamines can result in high blood pressure, headaches, sweating, heart palpitations, nausea, vomiting, and other symptoms. These tumors are considered dangerous because of their unpredictable behavior. Patients with pheochromocytoma may experience blood pressures high enough to cause a stroke or heart attack in patients. This study is designed to take patients suspected of having pheochromocytoma and confirm the diagnosis. This will be done using a variety of laboratory tests including a clonidine suppression test and glucagon stimulation test. These tests use drugs that can stimulate or reduce the activity of the tumor if it is present in the body. Once a diagnosis is confirmed, patients participating in this study will undergo standard procedures to find the exact location of the tumor and receive standard therapy for the condition.
Detailed Description
Patients suspected of having a pheochromocytoma will be studied via a series of tests in an attempt to ascertain biochemically whether or not they really have such a tumor. These procedures will include a standard clonidine suppression test and a standard glucagon stimulation test. Once the diagnosis has been made on the basis of biochemistry, then localization and therapy will be done via standard procedures. Measurement of plasma metanephrines on mailed samples is available for physicians who seek further evidence for the diagnosis of pheochromocytoma.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pheochromocytoma
Keywords
Calcium-Pentagastrin, Clonidine, Glucagon, Pheochromocytoma

7. Study Design

Enrollment
240 (false)

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Patients of any age and either sex who are suspected of having a pheochromocytoma on the basis of one or more of the following: 1. hypertensive episodes in a normotensive subject, 2. abnormal levels of blood and/or urinary catecholamines or their metabolites, or 3. an otherwise unexplained abdominal mass. Patients without any evidence of pheochromocytoma are excluded.
Facility Information:
Facility Name
National Heart, Lung and Blood Institute (NHLBI)
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20892
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
8607605
Citation
Elijovich F. Plasma metanephrines in the diagnosis of pheochromocytoma. Ann Intern Med. 1996 Apr 1;124(7):694-5. doi: 10.7326/0003-4819-124-7-199604010-00019. No abstract available.
Results Reference
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PubMed Identifier
2045133
Citation
Grossman E, Goldstein DS, Hoffman A, Keiser HR. Glucagon and clonidine testing in the diagnosis of pheochromocytoma. Hypertension. 1991 Jun;17(6 Pt 1):733-41. doi: 10.1161/01.hyp.17.6.733.
Results Reference
background
PubMed Identifier
5333928
Citation
Amery A, Conway J. A critical review of diagnostic tests for pheochromocytoma. Am Heart J. 1967 Jan;73(1):129-33. doi: 10.1016/0002-8703(67)90318-3. No abstract available.
Results Reference
background

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Diagnosis and Treatment of Pheochromocytoma

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