Recruiting
Phase 2

[68Ga]Ga-PentixaFor

Sponsor:

National Cancer Institute (NCI)

Code:

NCT06246357

Conditions

Hyperaldosteronism

Hypercortisolism

Cushing s Syndrome

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

[68Ga]Ga-PentixaFor

Study Details

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

Study ID

NCT06246357

Start date

Sep 23, 2024

Status verified date

Jun 24, 2026

Completion date

Apr 1, 2028

Anticipated

Primary completion date

Dec 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

  • 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.

Study Design

Enrollment

80 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

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

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

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).

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Yolanda L McKinney, R.N.

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

Maria Liza Lindenberg, M.D.

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

Locations

National Institutes of Health Clinical Center

Recruiting

Bethesda, Maryland, United States, 20892

Contacts

National Cancer Institute Referral Office

888-624-1937

More Information

Sponsor

National Cancer Institute (NCI)

Last update posted

Jun 29, 2026

Last verified

Jun 24, 2026

Keywords

  • Adenomas
  • PET Imaging

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by National Cancer Institute (NCI) on 2026-06-29.