Actively Recruiting
Phase 2 Study 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
17 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying adrenal tumors, which are growths on or near the adrenal glands that can be functional (releasing hormones) or nonfunctional. This study aims to see if a new radioactive tracer called [68Ga]Ga-PentixaFor can help identify functional adrenal tumors in people with hyperaldosteronism or hypercortisolism using PET scans. Knowing the tumor type helps doctors choose the best treatment. This is a Phase II study sponsored by the National Cancer Institute involving adults aged 18 and older who have adrenal tumors and increased hormone levels. Participants will receive an injection of [68Ga]Ga-PentixaFor about one hour before undergoing a PET/CT or PET/MR scan to capture images of their adrenal glands. The tracer dose is approximately 150 MBq, given through a vein. The imaging session lasts between 45 and 90 minutes. Participants will have their heart rate, blood pressure, and breathing monitored before, during, and after the scan. After the imaging, a safety check will happen three days later, which can be done by phone, email, or in person. During the study, participants will be screened and have imaging scans along with evaluations of their ability to perform daily activities. They may remain on study for up to one year for additional sample collection and analysis related to their adrenal condition. The main outcome measured is how well the [68Ga]Ga-PentixaFor imaging matches the clinical diagnosis of functional adrenal tumors. Safety and uptake thresholds of the tracer will also be evaluated throughout the study period.
CONDITIONS
Brief 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 trial 19-DK-0066, 09-C-0242, 18-CH-0031 or a similar study
- Be aged 18 years or older
- Have an ECOG performance status of 2 or less
- Women of child-bearing potential and men must agree to use effective contraception for two weeks before and one week after the scan
- Breastfeeding must be stopped 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 limit compliance with study requirements
- Contraindications to having an MRI or CT scan
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for screening and enrollment
Duration - 1 day
Participants undergo [68Ga]Ga-PentixaFor PET/CT or PET/MR imaging to evaluate adrenal gland function related to hyperaldosteronism and hypercortisolism.
1 imaging visit (in-person)
Duration - Up to 1 year
Participants have a safety visit 3 days after imaging and remain on study for up to 1 year for additional sample collection and assessments related to adrenal function and study analyses.
1 safety visit plus additional visits as needed for sample collection and assessments
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.
M
Maria Liza Lindenberg, M.D.
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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