FET PET/CT Imaging To Localize Pituitary Adenomas In Cushing Disease
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Fluoro-O-(2) fluoroethyl-L-tyrosine (FET) PET.
- Who it may be relevant to
- Registry conditions: Cushing Disease, Pituitary Adenoma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
18Fluoro-O-(2) Fluoroethyl-L-tyrosine (FET) PET For Localization Of Pituitary Adenomas In Patients With Cushing Disease
Overview
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.
Interventions
- Drug Fluoro-O-(2) fluoroethyl-L-tyrosine (FET) PET
Patients will receive intravenous administration of radiolabeled FET (5mCi ±10%) administered 20 minutes (±10minutes) prior to the initiation of the attenuation correction CT followed by the PET acquisition encompassing the participant's head/neck, centered on the pituitary gland.
Primary outcome measures
- Sensitivity of FET PET results in comparison to histopathology [Time frame: Baseline]
- Specificity of FET PET results in comparison to histopathology [Time frame: Baseline]
- Accuracy of FET PET results in comparison to histopathology [Time frame: Baseline]
Secondary outcome measures (1)
- Agreement of FET detection of ACTH-secreting pituitary with pituitary protocol MR [Time frame: Baseline]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
United States · 1 center
- Mayo Clinic in Rochester — Rochester
Identifiers
NCT: NCT07460232 · 22-006092