NCT06246357 Evaluating the Functional Status of the Adrenal Glands With [68Ga]Ga-PentixaFor in Hyperaldosteronism and Hypercortisolism
| NCT ID | NCT06246357 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | National Cancer Institute (NCI) |
| Condition | Hyperaldosteronism |
| Study Type | INTERVENTIONAL |
| Enrollment | 80 participants |
| Start Date | 2024-09-23 |
| Primary Completion | 2027-12-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 80 participants in total. It began in 2024-09-23 with a primary completion date of 2027-12-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Contact & Investigator
Maria Liza Lindenberg, M.D.
PRINCIPAL INVESTIGATOR
National Cancer Institute (NCI)
Frequently Asked Questions
Who can join the NCT06246357 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 120 Years, studying Hyperaldosteronism. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06246357 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT06246357 currently recruiting?
Yes, NCT06246357 is actively recruiting participants. Contact the research team at ymckinney@mail.nih.gov for enrollment information.
Where is the NCT06246357 trial being conducted?
This trial is being conducted at Bethesda, United States.
Who is sponsoring the NCT06246357 clinical trial?
NCT06246357 is sponsored by National Cancer Institute (NCI). The principal investigator is Maria Liza Lindenberg, M.D. at National Cancer Institute (NCI). The trial plans to enroll 80 participants.