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:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-26 @ 3:16 PM
NCT ID:
NCT07460232
Eligibility Criteria:
Inclusion Criteria:
Patients must meet ALL criteria listed below for entry:
* Biochemically diagnosed ACTH-dependent Cushing disease.
* No previous pituitary surgery.
* Planned to undergo pituitary surgery for localization/resection of adenoma.
* No contraindications for PET/CT.
* Recent (within 3 months) pituitary MR, or pending pituitary MR to be performed as close as possible to FET PET/CT.
* Age ≥ 18 years.
* Ability to provide informed consent.
Exclusion Criteria:
* Pregnant as determined by a pregnancy test as per institutional guidelines for individuals of child-bearing potential
* Declining to use effective contraceptive methods during the study (for individuals of child-bearing potential)
* Need for emergent surgery that would be delayed by participation
* Bacterial, viral, or fungal infections requiring systemic therapy
* Serious co-morbidities and serious nonmalignant disease (e.g., hydronephrosis, kidney failure, liver failure, systemic or local inflammatory or autoimmune diseases or other conditions) that in the opinion of the investigator could compromise patient safety and/or protocol objectives
* Known diagnosis of autoimmune disorders
* Patients receiving any other investigational agent within the past 28 days
* Breastfeeding. Note: nursing parents are allowed if the potential participant commits to pumping breast milk and discarding it from injection to ≥ 24 hours from the time of the FET injection.
* Known hypersensitivity to any excipients used in FET
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07460232
Study Brief:
Protocol Section:
NCT07460232