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Diagnostic Imaging for Pheochromocytoma

Phase 1

Recruiting

Led By Christina Tatsi, M.D.

Research Sponsored by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Highly suspected presence of PHEO/PGL based on imaging studies, even with normal biochemistry

Personal or family history of PHEO/PGL or genetic pathogenic variants known to predispose individuals to develop PHEO/PGL

Must not have

Severe cardiac dysfunction

In-person participating patients who are not willing to return to the NIH for more than 2 years

Timeline

Screening 3 weeks

Treatment Varies

Follow Up end of study

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing better methods to detect, locate, and treat pheochromocytomas. These are tumors that usually form in the adrenal glands and can cause high blood pressure. They can be hard to detect with current methods and can lead to severe medical consequences if left undetected.

Who is the study for?

This trial is for adults and children aged 3 years or older with known pheochromocytoma, a tumor that can cause high blood pressure. Participants need to have specific biochemical markers or genetic mutations indicative of the condition, be willing to provide samples, return for follow-up at NIH, and have an outside general practitioner. Pregnant women, those with severe heart issues or kidney dysfunction are excluded.

What is being tested?

The study aims to improve diagnosis and treatment of pheochromocytomas using various tests including blood/urine analysis for catecholamines/metanephrines, imaging scans like CT/MRI/PET with radioactive compounds ([18F]-6F-DA), ([18F]-DOPA), and genetic testing. Surgery may be offered if tumors are found; otherwise medical management will continue.

What are the potential side effects?

Potential side effects could include reactions to the contrast agent used in MRI (gadolinium) such as nausea or itching. The radioactive injections for PET scans might cause discomfort at the injection site or allergic reactions but these are generally rare.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My scans suggest I might have a pheochromocytoma or paraganglioma.

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I or my family have a history of PHEO/PGL or carry genes that increase the risk.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have severe heart problems.

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I am willing to visit the NIH for follow-ups for more than 2 years.

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My child cannot understand the study due to mental capacity.

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I am currently receiving dialysis.

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My child is under 10 years old.

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My child cannot stay still for long imaging sessions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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 ...

Secondary study objectives

To educate health care professionals and patients about pheochromocytoma and paraganglioma