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Diagnostic Imaging for Pheochromocytoma
Phase 1
Recruiting
Led By Karel Pacak, 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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up end of study
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
My scans suggest I might have a pheochromocytoma or paraganglioma.
Select...
I or my family have a history of PHEO/PGL or carry genes that increase the risk.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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 outcome measures
To educate health care professionals and patients about pheochromocytoma and paraganglioma
Trial Design
1Treatment groups
Experimental Treatment
Group I: Adults or children with suspected PHEO/PGLExperimental Treatment2 Interventions
Patients are adults or children of any age with known, sporadic or familial PHEO/PGL
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Who is running the clinical trial?
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)Lead Sponsor
1,965 Previous Clinical Trials
2,669,797 Total Patients Enrolled
1 Trials studying Pheochromocytoma
32 Patients Enrolled for Pheochromocytoma
Karel Pacak, M.D.Principal InvestigatorEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have severe heart problems.My scans suggest I might have a pheochromocytoma or paraganglioma.I am willing to visit the NIH for follow-ups for more than 2 years.My child cannot understand the study due to mental capacity.I or my family have a history of PHEO/PGL or carry genes that increase the risk.I am a relative of a patient in this study and may have hereditary PHEO/PGL.I am currently receiving dialysis.My child is under 10 years old.My child cannot stay still for long imaging sessions.I am 3 years or older with a diagnosis of PHEO/PGL.
Research Study Groups:
This trial has the following groups:- Group 1: Adults or children with suspected PHEO/PGL
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the size of the cohort engaging in this research?
"Affirmative. The clinical trial is currently enrolling participants, with the initial post dating back to March 22nd 2000 and last update occurring on October 29th 2022. 3000 patients will be recruited from two different locations for this study."
Answered by AI
Is this study actively seeking participants?
"Affirmative. Evidenced by the information stored on clinicaltrials.gov, this research endeavor is actively seeking volunteers; it was initially posted on March 22nd 2000 and updated most recently as of October 29th 2022. 3000 participants are needed from 2 distinct medical sites."
Answered by AI
Has ([18F]-6F-DA) acquired the endorsement of the Food and Drug Administration?
"The risk assessment score for ([18F]-6F-DA) was calculated to be 1 as this is a preliminary Phase 1 trial. It has limited evidence indicating its safety and effectiveness."
Answered by AI
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