Scientists hunt for better ways to spot hidden adrenal tumors
NCT ID NCT00004847
First seen Jun 27, 2026 · Last updated Sep 17, 2026 · Updated 13 times
Summary
This study aims to improve how doctors find and understand pheochromocytomas and paragangliomas, rare tumors that can cause dangerous high blood pressure. Researchers will use advanced imaging scans and genetic testing in up to 3,000 participants to learn more about these tumors. The goal is to develop better diagnostic methods and explore potential future treatments.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- radioactive tracers ([18F]-DOPA, [18F]-DA, [68Ga]-DOTATATE) for PET scans
- What this could lead to
- If successful, this research could lead to better ways to detect and understand these rare tumors, potentially improving treatment options in the future.
- What could go wrong
- This is an early-phase observational study focused on gathering knowledge, not testing a new treatment. It may not directly benefit participants or lead to immediate clinical changes.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 3,000 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2000
- Expected to finish
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Nov 2048
An estimate. End dates often move.
- Lead sponsor
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A government research agency
The lead sponsor is the US National Institutes of Health.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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3 to 120 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
* INCLUSION CRITERIA: Patients are eligible for inclusion in this study if they are adults or children of age 3 years old and up with known, sporadic or familial PHEO/PGL, on the basis of one or more of the following: 1. High levels of blood or urinary catecholamines, metanephrines, methoxytyramine or chromogranin A. 2. Highly suspected presence of PHEO/PGL based on imaging studies, even with normal biochemistry. 3. Personal or family history of PHEO/PGL or genetic pathogenic variants known to predispose individuals to develop PHEO/PGL. Signed informed consent is required. The informed consent may be signed by the patient, parent/guardian in pediatric patients or legally authorized representative (LAR) in adults who lack-decision making capacity to consent to research participation. Patients must have an outside general practitioner or endocrinologist. Patients with metastatic disease must also have an outside oncologist. Family Members of Patients Arm (Linkage Analysis) Participants are eligible for inclusion in this study arm if they are: * Adult family members of patients enrolled in this study; * The index family member in this study has a suspected hereditary PHEO/PGL based on previous genetic testing and other suspicious hereditory patterns such as family history of multiple individuals with PHEO/PGL; early age of disease onset; multiplicity of primary tumors; recurrence, etc. and * Signed informed consent form is required EXCLUSION CRITERIA: Potential patients will be excluded on the basis of one or more of the following: 1. Pregnant or breastfeeding women 2. Severe cardiac dysfunction 3. Currently on dialysis A pregnancy test is performed in women of childbearing age (up to age 55) as a screening after consenting. If a patient is found to have a positive pregnancy test, her participation in this protocol will be terminated. The patient can enroll or re-enroll in the protocol when she is no longer pregnant or breastfeeding. In-person participating patients who are not willing to return to the NIH (e.g., after surgery or an initial evaluation) for more than 2 years may be removed from the protocol. SPECIFIC INCLUSION/EXCLUSION CRITERIA FOR IMAGING STUDIES WITHIN OUR PROTOCOL: In adult patients (Excludes Linkage Analysis Arm) Imaging studies are not done in patients that have the following exclusion criteria: * Inability to lie still for the entire imaging time (e.g., cough, severe arthritis, etc.). * Inability to complete the needed investigational and standard-of-care imaging examinations due to other reasons (e.g., severe claustrophobia, radiation phobia, etc.) * Any additional medical conditions, serious illness, or other extenuating circumstance that, in the opinion of the Principal Investigator, may significantly interfere with study compliance. In pediatric patients: Inclusion criteria for research PET imaging in children: * 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. Exclusion criteria for research PET imaging in children: * Children of less than 10 years of age. * Children with impaired mental capacity that precludes informed assent. * Inability to lie still for the entire imaging time (e.g., cough, turbulent children, severe claustrophobia, etc.).
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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National Institutes of Health Clinical Center
RECRUITINGBethesda, Maryland, 20892, United States
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