Clinical trial · Interventional
FET PET/CT Imaging To Localize Pituitary Adenomas In Cushing Disease
18Fluoro-O-(2) Fluoroethyl-L-tyrosine (FET) PET For Localization Of Pituitary Adenomas In Patients With Cushing Disease
NCT07460232CI-TRIAL-00115434recruitingEarly Phase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cushing Disease | — | UNRESOLVED | — |
| Pituitary Adenoma | Pituitary Neuroendocrine Tumor | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Fluoro-O-(2) fluoroethyl-L-tyrosine (FET) PET | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- (ACTH)-dependent Cushing disease
- description
- Patients with adrenocorticotropic hormone (ACTH)-dependent Cushing disease who may be considered candidates for surgical treatment
- interventionNames
- Drug: Fluoro-O-(2) fluoroethyl-L-tyrosine (FET) PET
Primary outcomes (3)
- measure
- Sensitivity of FET PET results in comparison to histopathology
- timeFrame
- Baseline
- description
- Percentage of cases where surgical findings and pathology are in agreement with \[18F\]FET-PET/MRI imaging
- measure
- Specificity of FET PET results in comparison to histopathology
- timeFrame
- Baseline
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.