Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 6:55 PM
Ignite Modification Date:
2025-12-24 @ 6:55 PM
NCT ID:
NCT06246357
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
120 Years
Study:
NCT06246357
Study Brief:
Protocol Section:
NCT06246357