Diagnosis of Pheochromocytoma
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|ClinicalTrials.gov Identifier: NCT00004847|
Recruitment Status : Recruiting
First Posted : March 3, 2000
Last Update Posted : June 9, 2020
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:
- 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.
- 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.
- 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.
- Genetic testing - A small blood sample is collected for DNA analysis and other analyses.
|Condition or disease||Intervention/treatment||Phase|
|Pheochromocytoma Endocrine Disease Endocrine Diseases||Drug: ([18F]-DOPA) Drug: [68Ga]-DOTATATE Drug: ([18F]-6F-DA)||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||2400 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Diagnosis, Pathophysiology, and Molecular Biology of Pheochromocytoma and Paraganglioma|
|Actual Study Start Date :||March 22, 2000|
|Estimated Primary Completion Date :||November 30, 2048|
|Estimated Study Completion Date :||November 30, 2048|
Experimental: Adults or children with suspected PHEO/PGL
Patients are adults or children of any age with known, sporadic or familial PHEO/PGL
is L 3, 4 dihydroxyphenylalanine (L-DOPA) labeled with the radioactive isotope 18F. In general, PPGLs belong to the group of neuroendocrine tumors. This heterogeneous group of tumors takes up amino acids, transforms them into biogenic amines (dopamine and serotonin) by decarboxylation and stores the amines in vesicles. L DOPA is a precursor of catecholamines (dopamine, norepinephrine and epinephrine). Epinephrine conversion to dopamine is catalyzed by the aromatic amino acid decarboxylase. According to previous and current studies, [18F]-DOPA PET is highly sensitive and specific for detection of PHEO /PGL67-69. However, there are only a few reports in the literature using [18F]-DOPA as a PET agent and particularly for patients with metastatic PPGLs. PET imaging will be done together with either a CT, an MRI or both modalities.
is an imaging agent that binds specifically to somatostatin receptors (SSTRs). PPGLs similar to other neuroendocrine tumors express one or more SSTRs1-5. According to previous and current studies, [68Ga]-DOTATATE PET is highly sensitive and specific for the detection of PHEO/PGL and other neuroendocrine tumors.
is an imaging agent developed at the NIH, that may improve specificity and sensitivity in the localization of PPGLs. [18F]-6F-DA enters cells via the membrane norepinephrine transporter. Once inside cells, [18F]-6F- DA is translocated via the vesicular monoamine transporter into storage vesicles, where the radioactivity is concentrated. After injection of [18F]-6F- DA, the much faster disappearance of [18F]-6F-DA-derived radioactivity from the bloodstream and non- neuronal cells than from chromaffin cells should enable rapid visualization of PPGLs by PET scanning.
- To study specific genotypes, biochemical and imaging phenotypes of patients with various pheochromocytomas and paragangliomas. To stuty potential treatment options for metastatic pheochromocytoma and paraganglioma using cell cultures, cell lines... [ Time Frame: Baseline ]To study specific genotypes, biochemical and imaging phenotypes of patients with various pheochromocytomas and paragangliomas. Tostuty potential treatment options for metastatic pheochromocytoma and paraganglioma using cell cultures, cell lines, animal
- To educate health care professionals and patients about pheochromocytoma and paraganglioma [ Time Frame: Ongoing ]To educate health care professionals and patients about pheochromocytoma and paraganglioma
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00004847
|Contact: Tamara P Prodanov, M.D.||(301) firstname.lastname@example.org|
|Contact: Karel Pacak, M.D.||(301) email@example.com|
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike||Recruiting|
|Bethesda, Maryland, United States, 20892|
|Contact: For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR) 800-411-1222 ext TTY8664111010 firstname.lastname@example.org|
|Principal Investigator:||Karel Pacak, M.D.||Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)|