BridgeMD
New treatment option for Cushing Disease
Official title FET PET/CT Imaging To Localize Pituitary Adenomas In Cushing Disease
ClinicalTrials.gov ID: NCT07460232
What this study is testing
What is Fluoro-O-(2) fluoroethyl-L-tyrosine (FET) PET?
Fluoro-O-(2) fluoroethyl-L-tyrosine (FET) PET is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for cushing disease.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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.
You likely can't join if
- 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...
- Known diagnosis of autoimmune disorders
See the full eligibility 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.
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Rochester, Minnesota, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Rochester, Minnesota, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.