FET PET/CT Imaging To Localize Pituitary Adenomas In Cushing Disease (NCT07460232) | Clinical Trial Compass
RecruitingEarly Phase 1
FET PET/CT Imaging To Localize Pituitary Adenomas In Cushing Disease
United States50 participantsStarted 2026-04-27
Plain-language summary
The purpose of this research is to evaluate the performance \[sensitivity, specificity, accuracy\] of FET PET/CT imaging to detect ACTH-secreting pituitary adenoma, using operative findings and histopathology as truth standard.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Sensitivity of FET PET results in comparison to histopathology
Timeframe: Baseline
2
Specificity of FET PET results in comparison to histopathology
Timeframe: Baseline
3
Accuracy of FET PET results in comparison to histopathology