NCT06246357

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

Recruiting now Phase 2 Last updated 9 December 2025

What this trial tests

Phase 2 trial testing [68Ga]Ga-PentixaFor in Hyperaldosteronism in 80 participants. Currently enrolling.

Timeline

23 September 2024

Primary endpoint
1 December 2027

1 April 2028

Quick facts

Lead sponsor	National Cancer Institute (NCI)
Phase	Phase 2
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	diagnostic
Enrollment	80
Start date	23 September 2024
Primary completion	1 December 2027
Estimated completion	1 April 2028
Sites	1 location across United States

Drugs / interventions tested

• [68Ga]Ga-PentixaFor — full drug profile →

Conditions studied

• Hyperaldosteronism — all drugs for Hyperaldosteronism →
• Hypercortisolism — all drugs for Hypercortisolism →
• Cushing s Syndrome — all drugs for Cushing s Syndrome →

Sponsor

National Cancer Institute (NCI)

Who can join

Adults 18 to 120, any sex, with Hyperaldosteronism or Hypercortisolism. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Selective PET imaging of CXCR4 using the Al¹⁸F-labeled antagonist LY2510924.
   Spahn MA, Loy TV, Celen S, Koole M, et al · · 2025 · cited 4× · PMID 39658737 · DOI 10.1007/s00259-024-07025-w