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) PET/CT. These scans may be done before and/or 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 PET/CT . Each scan takes up to about
2 hours.
4. Genetic testing - A small blood sample is collected for DNA analysis and other analyses.
Phase:
Phase 1
Details
Lead Sponsor:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)