FET PET/CT Imaging To Localize Pituitary Adenomas In Cushing Disease
Recruiting
Early Phase 1Interventional Study
Cushing DiseasePituitary Adenoma
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Trial phase
Early Phase 1
Study type
Interventional
Purpose
Diagnostic
Participants needed
50 (estimated)
Sponsor
Mayo Clinic · Other
Who this trial is looking for
This trial is looking for adults with a specific type of hormone disorder called ACTH-dependent Cushing disease. Participants will undergo special imaging to help locate a pituitary tumor before surgery.
Are You a Good Fit for This Trial?
Rules you outAutoimmune disorders
You may be able to join if
I have been diagnosed with ACTH-dependent Cushing disease.
I have not had any pituitary surgery before.
I plan to have surgery to remove the tumor.
I have no issues that prevent me from having a PET/CT scan.
I have had a pituitary MRI within the last 3 months, or I will have one before the imaging.
I am 18 years or older.
I can give my informed consent.
You may not be able to join if
I am pregnant.
I refuse to use effective birth control during the study.
I need to have surgery right away that cannot wait for this trial.
I have an infection that needs treatment.
I have a serious health condition that could affect my safety or the study.
I have been diagnosed with an autoimmune disorder.
I have taken any other experimental drug in the past 28 days.
I am breastfeeding and cannot wait to discard milk for 24 hours after the FET injection.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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.
Trial Locations
Loading…
Loading trial locations…
Facility
City
State
Country
Status
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…
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
Picking one helps us show the most relevant trials first.
Your results are loading in the background — you can
change this any time from the results page.
Set your location to continue
Find My Trials uses your location to surface clinical trials near you.
Add your city or zip code to your profile and try again.
