Actively Recruiting

Phase 1
Age: 3Years - 120Years
All Genders
NCT00004847

Diagnosis of Pheochromocytoma

Led by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) · Updated on 2026-05-07

3000

Participants Needed

1

Research Sites

2540 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Diagnosis of Pheochromocytoma

Who Can Participate

Age: 3Years - 120Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults and children aged 3 years and older with known or suspected pheochromocytoma or paraganglioma
  • High levels of blood or urine catecholamines, metanephrines, methoxytyramine, or chromogranin A
  • Suspicion of pheochromocytoma or paraganglioma based on imaging studies
  • Personal or family history of pheochromocytoma or paraganglioma or known genetic variants predisposing to these tumors
  • Signed informed consent by patient, parent/guardian, or legally authorized representative
  • Patients must have an outside general practitioner or endocrinologist; metastatic patients must also have an outside oncologist
  • Adult family members of patients with suspected hereditary pheochromocytoma or paraganglioma with signed informed consent
  • Children over 10 years old with high suspicion of pheochromocytoma or paraganglioma for research PET imaging
  • Children must give informed assent and be willing to return for follow-up
Not Eligible

You will not qualify if you...

  • Pregnant or breastfeeding women
  • Severe cardiac dysfunction
  • Currently on dialysis
  • Positive pregnancy test in women of childbearing age
  • Unwillingness to return for follow-up visits for more than 2 years
  • Inability to lie still for the entire imaging procedure (e.g., due to cough, severe arthritis, claustrophobia)
  • Any medical condition or serious illness that could interfere with study compliance
  • Children under 10 years old for research PET imaging
  • Children with impaired mental capacity preventing informed assent

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

National Institutes of Health Clinical Center

Bethesda, Maryland, United States, 20892

Actively Recruiting

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Research Team

A

Alberta Derkyi, C.R.N.P.

CONTACT

C

Catherine M Gordon, M.D.

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

DIAGNOSTIC

Number of Arms

1

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