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

NCT ID: NCT06246357

Last Updated: 2025-12-09

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-23
• Study Completion Date: 2028-04-01

Brief 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.

Detailed 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 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)
• 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 up to 1 year to allow the collection of samples for correlative analysis from the parent protocol (adrenal venous sampling, imaging assessments, laboratory evaluations, and/or tissue samples).

Conditions

Hyperaldosteronism; Hypercortisolism; Cushing s Syndrome

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

1/[68Ga]Ga-PentixaFor PET/CT or PET/MR

Participants will undergo \[68Ga\]Ga-PentixaFor PET/CT or PET/MR

Group Type: EXPERIMENTAL

[68Ga]Ga-PentixaFor

Intervention Type: DRUG

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

Interventions

[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).

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Maria Liza Lindenberg, M.D.

Role: PRINCIPAL_INVESTIGATOR

National Cancer Institute (NCI)

Locations

National Institutes of Health Clinical Center

Bethesda, Maryland, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Yolanda L McKinney, R.N.

Role: CONTACT

ymckinney@mail.nih.gov

(240) 760-6095

Maria Liza Lindenberg, M.D.

Role: CONTACT

liza.lindenberg@mail.nih.gov

(240) 760-6109

Facility Contacts

National Cancer Institute Referral Office

Role: primary

888-624-1937

Related Links

https://clinicalstudies.info.nih.gov/cgi/detail.cgi?A_001600-C.html

NIH Clinical Center Detailed Web Page

Other Identifiers

001600-C

Identifier Type: -

Identifier Source: secondary_id

10001600

Identifier Type: -

Identifier Source: org_study_id