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

Launched by NATIONAL CANCER INSTITUTE (NCI) · Feb 6, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new method to identify adrenal tumors that produce excess hormones, specifically focusing on conditions like hyperaldosteronism and Cushing's syndrome. The researchers want to see if a special radioactive substance called \[68Ga\]Ga-PentixaFor will help doctors better visualize these functional tumors using a type of imaging called a PET scan. This could lead to improved treatment options for patients with these conditions.

To participate in the trial, individuals must be at least 18 years old and have one or more adrenal tumors along with high levels of hormones like aldosterone or cortisol. Participants will receive a PET scan after being given the tracer through a small needle in their arm. The scan will take about 45 to 90 minutes, and a follow-up visit will occur three days later, which can be done by phone or in person. It's important to note that participants should also be enrolled in another related study and must agree to certain safety measures, such as using contraception if they are of childbearing potential.

Gender

ALL

Eligibility criteria

• * INCLUSION CRITERIA:
• * Must have either of the following:
• • one or more adrenal masses on CT and/or MRI with biochemical evidence of excess aldosterone or ACTH-independent hypercortisolism, OR
• • 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 CRITERIA:
• • 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.