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New treatment option for Pheochromocytoma
Official title Diagnosis of Pheochromocytoma
ClinicalTrials.gov ID: NCT00004847
What this study is testing
What is ([18F]-DOPA)?
([18F]-DOPA) is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for pheochromocytoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 3 to 120
You may be able to join if
- 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...
- High levels of blood or urinary catecholamines, metanephrines, methoxytyramine or chromogranin A.
- 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. Signed informed consent is...
- Adult family members of patients enrolled in this study;
You likely can't join if
- Potential patients will be excluded on the basis of one or more of the following:
- Pregnant or breastfeeding women
- Severe cardiac dysfunction
- 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...
- 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...
See the full eligibility 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:
- High levels of blood or urinary catecholamines, metanephrines, methoxytyramine or chromogranin A.
- 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. Signed informed consent is required. The informed consent may be signed by the patient...
- 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...
- Signed informed consent form is required
- Potential patients will be excluded on the basis of one or more of the following:
- Pregnant or breastfeeding women
- Severe cardiac dysfunction
- 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...
- 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...
- 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.).
The study team makes the final eligibility decision.
Where it's taking place
- Bethesda, Maryland, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 3 years to 120 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bethesda, Maryland, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.