Evaluating adrenal gland function using a new imaging agent in patients with hormone-related conditions

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

This study is testing a new imaging agent to see if it can help find adrenal tumors in adults with hormone-related conditions like hyperaldosteronism or hypercortisolism.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 80 (estimated)
• Ages: 18 Years to 120 Years
• Sex: All
• Sponsor: National Institutes of Health Clinical Center (CC) (NIH)
• Locations: 1 site (Bethesda, Maryland)
• Trial ID: NCT06246357 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to assess the effectiveness of a new radioactive tracer, [68Ga]Ga-PentixaFor, in identifying functional adrenal tumors through positron emission tomography (PET) scans. The study will enroll participants aged 18 and older who have adrenal tumors and elevated hormone levels related to hyperaldosteronism or hypercortisolism. Participants will be categorized into three cohorts based on their specific adrenal conditions and will undergo imaging scans to evaluate the concordance of the new imaging agent with clinical diagnoses. The goal is to improve the identification of functional tumors, which is crucial for determining appropriate treatment options.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with adrenal tumors and elevated levels of aldosterone or cortisol.

Not a fit: Patients without adrenal tumors or those with non-functional tumors may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to more accurate identification of functional adrenal tumors, improving treatment decisions for patients.

How similar studies have performed: While the use of [68Ga]Ga-PentixaFor is a novel approach, similar imaging techniques have shown promise in identifying functional tumors in other contexts.

Eligibility criteria

* INCLUSION CRITERIA:
* Must have any of the following:

  * one or more adrenal masses on CT and/or MRI and biochemical evidence of excess aldosterone

OR

--ACTH-independent hypercortisolism, with or without adrenal masses on CT and/or MRI

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.

Where this trial is running

Bethesda, Maryland

• National Institutes of Health Clinical Center — Bethesda, Maryland, United States (Recruiting)

Study contacts

• Principal investigator: Maria Liza Lindenberg, M.D. — National Cancer Institute (NCI)
• Study coordinator: Yolanda L McKinney, R.N.

Conditions Hyperaldosteronism; Hypercortisolism; Cushing s Syndrome; Adenomas; PET Imaging