RecruitingPhase 2NCT06246357

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

Phase 2 Study Evaluating the Functional Status of the Adrenal Glands With [68Ga]Ga-PentixaFor in Hyperaldosteronism and Hypercortisolism


Sponsor

National Cancer Institute (NCI)

Enrollment

80 participants

Start Date

Sep 23, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 YearsMax Age: 120 Years

Plain Language Summary

Simplified for easier understanding

This study tests an imaging technique using a radioactive tracer called [68Ga]Ga-PentixaFor in a PET scan to evaluate the function of the adrenal glands in patients with overproduction of certain hormones — either too much aldosterone (which raises blood pressure) or too much cortisol (which causes Cushing's syndrome or similar conditions). **You may be eligible if...** - You are 18 or older - You have one or more tumors on your adrenal gland AND laboratory evidence of excess aldosterone production, OR - You have evidence of cortisol overproduction that is not driven by the pituitary gland (ACTH-independent), with or without visible adrenal tumors, OR - You have a history of cortisol overproduction driven by the pituitary gland - You are also enrolled in a related NIH study - You are willing to use contraception around the time of the scan **You may NOT be eligible if...** - You are pregnant or breastfeeding - Your kidney function is too impaired for the scan contrast - You are unable to lie still for imaging Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUG[68Ga]Ga-PentixaFor

\[68Ga\]Ga-PentixaFor will be injected intravenously approximately 60 minutes prior to scanning at a dose of 150 +/- 50 MBq (4 mCi +/- 1.4).


Locations(1)

National Institutes of Health Clinical Center

Bethesda, Maryland, United States

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NCT06246357


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