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Evaluating [68Ga]Ga-PentixaFor for Adrenal Gland Function

This study is looking at a new way to identify functional adrenal tumors, which are growths on your adrenal glands (two small organs above your kidneys) that release hormones. Researchers are using a special tracer called [68Ga]Ga-PentixaFor with PET scans (a type of imaging) to see if it can accurately find these tumors. You may be able to join if you are 18 or older, have one or more adrenal masses, and have high levels of hormones like aldosterone or cortisol. The main goal is to see how well the [68Ga]Ga-PentixaFor imaging matches up with your clinical diagnosis in finding these functional tumors.

Study design
This is a Phase II, single-site study planning to enroll 80 participants. It is an interventional study, meaning participants will receive a specific treatment or intervention.
What's involved
[68Ga]Ga-PentixaFor will be injected intravenously approximately 60 minutes before a scan. The dose will be 150 +/- 50 MBq (4 mCi +/- 1.4).
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint, which assesses the imaging's accuracy, is measured at screening. Further follow-up details are not specified.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06246357

Evaluating the Functional Status of the Adrenal Glands With [68Ga]Ga-PentixaFor in Hyperaldosteronism and Hypercortisolism

Recruiting
PHASE2Ages 18+InterventionalDiagnostic
National Cancer Institute (NCI)
~80 participants
Updated 2026-06-29 on ClinicalTrials.gov
What's tested:[68Ga]Ga-PentixaFor

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Estimate the percent concordance of [68Ga]Ga-PentixaFor imaging with clinical diagnosis in identifying functional adrenal or extra-adrenal adenomas in hyperaldosteronism and hypercortisolism
Measured over Screening

Conditions

Hyperaldosteronism
Hypercortisolism
Cushing s Syndrome

Explore related trials

Cushing SyndromeHyperaldosteronismHypercortisolemia

Where it's being run

1 sites across 1 states
Maryland1

Study leadership

  • Maria Liza Lindenberg, M.D. · PRINCIPAL_INVESTIGATOR · National Cancer Institute (NCI)

Who to contact

Yolanda L McKinney, R.N.
[email protected]
(240) 760-6095
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Must have any of the following:
one or more adrenal masses on CT and/or MRI and biochemical evidence of excess aldosterone
ACTH-independent hypercortisolism, with or without adrenal masses on CT and/or MRI
history of ACTH-dependent hypercortisolism (with or without adrenal enlargement)
Co-enrollment in 19-DK-0066, 09-C-0242, 18-CH-0031 or a similar NIH trial.
Age \>=18 years.
ECOG performance status \<= 2.
Women of child-bearing potential (WOCBP) and men must agree to use an effective contraception (barrier, hormonal, intrauterine device \[IUD\], surgical sterilization, abstinence) for two weeks prior to \[68Ga\]Ga-PentixaFor scan and for one week after the \[68Ga\]Ga-PentixaFor scan.
Breastfeeding should be discontinued for one week after the \[68Ga\]Ga-PentixaFor scan.
Men must agree not to donate sperm for one week after the \[68Ga\]Ga-PentixaFor scan.
Participants must be able to understand and willing to sign a written informed consent document.

Exclusion

Positive beta-human chorionic gonadotropin (beta-HCG) serum or urine pregnancy test performed in females of childbearing potential at screening.
Uncontrolled intercurrent illness or social situations based on the review of medical history that would limit compliance with study requirements.
Contraindications to having an MRI and CT.

What this trial measures

  • Estimate the percent concordance of [68Ga]Ga-PentixaFor imaging with clinical diagnosis in identifying functional adrenal or extra-adrenal adenomas in hyperaldosteronism and hypercortisolismScreening

    The percent concordance between \[68Ga\]Ga-PentixaFor and clinical diagnosis will be estimated within each Cohort, along with 90% Clopper-Pearson confidence intervals.