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

Hyperaldosteronism Clinical Trial

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

Status Not yet recruiting

Clinical Trial 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.

Clinical Trial Description

Background:

• [68Ga]Ga-PentixaFor is a PET agent targeting the C-X-C chemokine receptor type 4 (CXCR4) with promising applications in oncology, cardiology, and infectious disease.

• CXCR4 has also been noted to show high expression in many aldosterone-producing adenomas (APA) and some cortisol-producing adenomas (CPA) but not usually in nonfunctioning adenomas.

• [68Ga]Ga-PentixaFor may be useful in the evaluation of adrenal adenomas in the setting of Conn s or Cushing s syndrome. Localizing functional adenomas is important for managing treatment options but current imaging modalities are either too invasive or insufficiently able to differentiate adrenal conditions.

Objective:

-To estimate the percent concordance of [68Ga]Ga-PentixaFor imaging with clinical diagnosis in identifying functional adrenal or extra-adrenal adenomas in hyperaldosteronism and hypercortisolism

Eligibility:

• 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).

• Age >= 18 years

• ECOG performance status <= 2

Design:

• This is a Phase II, single site study where participants from three cohorts are enrolled into one arm according to their probable disease: primary aldosteronism (Cohort 1), ACTHindependent Cushing s syndrome (Cohort 2), or ACTH-dependent Cushing s syndrome (Cohort 3).

• All participants will undergo a [68Ga]Ga-PentixaFor PET/CT or [68Ga]Ga-PentixaFor PET/MR.

• A safety visit will be performed 3 days following the [68Ga]Ga-PentixaFor imaging.

• Participants will remain on-study for 1 year until samples are obtained for correlative analysis from the parent protocol (adrenal venous sampling, imaging assessments, laboratory evaluations, and/or tissue samples).

• To account for inevaluable participants, the accrual ceiling will be set to 77 maximum participants with the number of evaluable participants enrolled as follows: 20 for Cohort 1, 20 for Cohort 2, and 30 for Cohort 3. ;

Related Conditions & MeSH terms

• Adrenocortical Hyperfunction
• Cushing Syndrome
• Hyperaldosteronism
• Hypercortisolism

• NCT number: NCT06246357
• Study type: Interventional
• Source: National Institutes of Health Clinical Center (CC)
• Contact: Yolanda McKinney, R.N.
• Phone: (240) 760-6095
• Email: ymckinney@mail.nih.gov
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: June 26, 2024
• Completion date: April 1, 2028