Actively Recruiting
Evaluating the Functional Status of the Adrenal Glands With [68Ga]Ga-PentixaFor in Hyperaldosteronism and Hypercortisolism
Led by National Cancer Institute (NCI) · Updated on 2025-12-09
80
Participants Needed
1
Research Sites
183 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Background: The adrenal glands are 2 small organs that sit on top of each kidney. They release hormones; these are chemicals that control how the body works. Tumors on or outside the adrenal glands are called functional if they release hormones; they are called nonfunctional if they do not. Doctors who treat adrenal tumors need to know which type a person has. Researchers want to find better ways to learn whether an adrenal tumor is functional. Objective: To see if a new radioactive tracer (\[68Ga\]Ga-PentixaFor) can make it easier to identify functional adrenal tumors with positron emission tomography (PET) scans. Eligibility: People aged 18 years and older with 1 or more adrenal tumors. They must have increased levels of the hormones aldosterone or cortisol. They must also be enrolled in at least 1 other related NIH study (protocols 19-DK-0066, 18-CH-0031, or 09-C-0242). Design: Participants will be screened. They may have imaging scans. Their ability to perform normal activities will be reviewed. Participants will have one PET scan with the study tracer. The tracer will be given through a tube attached to a needle inserted into a vein. Participants will receive the tracer 1 hour before the scan. They will lie still on a bed while a machine captures images of the inside of their body. The scan will take 45 to 90 minutes. Participants heart rate, blood pressure, and rate of breathing will be checked before, during, and after the scan. Participants will have a follow-up visit 3 days after their scan. This visit can be by phone, email, or in person.
CONDITIONS
Official Title
Evaluating the Functional Status of the Adrenal Glands With [68Ga]Ga-PentixaFor in Hyperaldosteronism and Hypercortisolism
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Must have one or more adrenal masses on CT and/or MRI with biochemical evidence of excess aldosterone
- Or have ACTH-independent hypercortisolism, with or without adrenal masses on CT and/or MRI
- Or have a history of ACTH-dependent hypercortisolism, with or without adrenal enlargement
- Be co-enrolled in NIH protocols 19-DK-0066, 09-C-0242, 18-CH-0031, or similar trials
- Be 18 years of age or older
- Have an ECOG performance status of 2 or less
- Agree to use effective contraception if of child-bearing potential, including barrier, hormonal, intrauterine device, surgical sterilization, or abstinence, starting two weeks before and continuing one week after the [68Ga]Ga-PentixaFor scan
- Discontinue breastfeeding for one week after the scan
- Men must agree not to donate sperm for one week after the scan
- Be able to understand and willing to sign informed consent
You will not qualify if you...
- Positive pregnancy test in females of childbearing potential at screening
- Uncontrolled illness or social situations that would limit compliance with study requirements
- Contraindications to MRI or CT scans
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
National Institutes of Health Clinical Center
Bethesda, Maryland, United States, 20892
Actively Recruiting
Research Team
Y
Yolanda L McKinney, R.N.
CONTACT
M
Maria Liza Lindenberg, 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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