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

NCT06246357 | Recruiting Phase 2 FDA Drug

• 2 other identifiers: 10001600001600-C
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Hyperaldosteronism; Hypercortisolism; Cushing s Syndrome

Keywords

Adenomas; PET Imaging

Outcome Measures

Primary Outcomes (1)

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

  The percent concordance between \[68Ga\]Ga-PentixaFor and clinical diagnosis will be estimated within each Cohort, along with 90% Clopper-Pearson confidence intervals.

  Screening

Secondary Outcomes (3)

• Compare [68Ga]Ga-PentixaFor uptake to C-X-C chemokine receptor type 4 (CXCR4) expression in resected tissue (when obtained on parent protocol)

  Within 1 year following [68Ga]Ga-PentixaFor imaging

• Evaluate threshold values of [68Ga]Ga-PentixaFor uptake for determining adrenal mass hyperfunction

  Within 1 year following [68Ga]Ga-PentixaFor imaging

• Estimate the safety of [68Ga]Ga-PentixaFor

  Day of [68Ga]Ga-PentixaFor administration until end of study participation

Study Arms (1)

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

EXPERIMENTAL

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

Drug: [68Ga]Ga-PentixaFor

Interventions

[68Ga]Ga-PentixaFor 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).

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

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Must have any of the following:
• one or more adrenal masses on CT and/or MRI and biochemical evidence of excess aldosterone
• ACTH-independent hypercortisolism, with or without adrenal masses on CT and/or MRI
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

RECRUITING

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Hyperaldosteronism; Cushing Syndrome; Adenoma

Condition Hierarchy (Ancestors)

Adrenocortical Hyperfunction; Adrenal Gland Diseases; Endocrine System Diseases; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms

Study Officials

• Maria Liza Lindenberg, M.D.

  National Cancer Institute (NCI)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yolanda L McKinney, R.N.

CONTACT

(240) 760-6095; ymckinney@mail.nih.gov

Maria Liza Lindenberg, M.D.

CONTACT

(240) 760-6109; liza.lindenberg@mail.nih.gov

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2024
• First Posted: February 7, 2024
• Study Start: September 23, 2024
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): April 1, 2028
• Last Updated: December 9, 2025

Record last verified: 2025-12-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: This study will comply with the NIH Data Management and Sharing (DMS) Policy, which applies to all new and ongoing NIH-funded research in the IRP, as of January 25, 2023, that is associated with a ZIA, with a clinical protocol that undergoes scientific review.
• Access Criteria: Clinical data will be made available via subscription to BTRIS and with the permission of the study PI.

Locations

US (1)