Diagnosis, Pathophysiology, and Molecular Biology of Pheochromocytoma and Paraganglioma

Who is this study for? Patients with Myocardial Infarction
What treatments are being studied? ([18F]-DOPA)+([18F]-6F-DA)
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
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) 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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 3
Maximum Age: 120
Healthy Volunteers: f
View:

• Children over 10 years old with very high suspicion of sporadic or familial PHEO/PGL based on at least one of the following:

‣ The presence of new onset of symptoms typical of PHEO/PGL such as hypertension or hypertensive episodes, sweating, headaches, pallor, palpitations, drug resistant hypertension, etc.

⁃ Family history of PHEO/PGL or genetic pathogenic variants known to predispose individuals to develop these tumors.

⁃ The presence of a tumor on conventional imaging including ultrasound, CT and/or MRI or \[123I\]-MIBG or PET imaging not limited to \[18F\]-FDG.

• Children must give informed assent and be willing to return to the NIH for follow-up.

Locations
United States
Maryland
National Institutes of Health Clinical Center
RECRUITING
Bethesda
Contact Information
Primary
Alberta Derkyi, C.R.N.P.
alberta.derkyi@nih.gov
(301) 827-3355
Backup
Catherine M Gordon, M.D.
catherine.gordon@nih.gov
(301) 827-5449
Time Frame
Start Date: 2000-03-22
Estimated Completion Date: 2048-11-30
Participants
Target number of participants: 3000
Treatments
Experimental: Adults or children with suspected PHEO/PGL
Patients are adults or children of any age with known, sporadic or familial PHEO/PGL
Authors
Karel Pacak
Related Therapeutic Areas
Sponsors
Leads: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

This content was sourced from clinicaltrials.gov