Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004847
Status:
RECRUITING
Last Update Posted:
2024-07-12
First Post:
2000-03-02
Brief Title:
Diagnosis of Pheochromocytoma
Sponsor:
Eunice Kennedy Shriver National Institute of Child Health and Human Development NICHD
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Diagnosis Pathophysiology and Molecular Biology of Pheochromocytoma and Paraganglioma
Status:
RECRUITING
Status Verified Date:
2024-09-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 PETCT These scans may be done before andor 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 PETCT Each scan takes up to about 2 hours
4 Genetic testing - A small blood sample is collected for DNA analysis and other analyses
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 PETCT These scans may be done before andor 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 PETCT Each scan takes up to about 2 hours
4 Genetic testing - A small blood sample is collected for DNA analysis and other analyses
Detailed Description:
Pheochromocytomas PHEOs and paragangliomas PGLs are rare and clinically important chromaffin cell tumors that typically arise from the adrenal gland or from extra-adrenal paraganglia respectively The clinical features and consequences of PHEOPGL result from the release of catecholamines norepinephrine andor epinephrine An undetected PHEOPGL poses a hazard to patients undergoing surgery childbirth or general anesthesia due to the potential for excess catecholamine secretion which can result in significant often catastrophic outcomes Diagnosing and localizing a PHEOPGL can be challenging Plasma and urinary catecholamines as well as their metabolites and radio-iodinated metaiodobenzylguanidine MIBG scanning can yield false-positivenegative results in patients harboring the tumor Computed tomography CT and magnetic resonance imaging MRI lack sufficient specificity The molecular mechanisms by which genotypic changes predispose to the development of PHEOPGL remain unknown - even in patients with identified pathogenic variants Moreover in patients with hereditary predispositions PHEOsPGLs differ in terms of their growth malignant potential catecholamine phenotype responses to standard screening tests various imaging modalities and therefore subsequently different therapeutic options This protocol focuses on developmental molecular genetic epigenetic proteomic metabolomics immunologic and other types of studies to investigate the bases for predisposition to develop PHEOsPGLs and for expression of different neurochemical and other phenotypes and malignant potentials including therapeutic responses Furthermore this protocol will also use new imaging approaches for example 18F-6F-dopamine 18F-6F-DA and 18F-L-34-dihydroxyphenylalanine 18F-FDOPA positron emission tomography PETCT as well as dynamic contrast-enhanced MRI
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 00-CH-0093 | None | None | None |