An observational study in Cushing Disease and ACTH-producing Pituitary Tumour, sponsored by Hospices Civils de Lyon. Recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-11.
Sponsored by Hospices Civils de Lyon · Observational
Cushing's disease results from adrenocorticotropic hormone (ACTH) secretion by corticotroph pituitary neuroendocrine tumors (PitNETs). Magnetic resonance imaging (MRI) is the reference modality for etiological diagnosis but may to visualize small corticotroph microadenomas in up to 30% of the cases, and false positives may occur.
The study hypothesis is that positron emission tomography (PET) using [18F]fluoroethyl-L-tyrosine ([18F]FET) improves localization of ACTH-secreting corticotroph microadenomas compared with MRI and could inform surgical planning and reduce reliance on invasive inferior petrosal sinus sampling.
This observational cohort (retrospective and prospective data) will assess the diagnostic performance of [18F]FET PET for tumor localization using postoperative histopathology as the gold standard.
Secondary aims include:
64 studies on the registry are indexed under Pituitary ACTH Hypersecretion; 16 are open to participants now.
This study's planned enrollment of 20 is below the median of 131 across 20 observational studies indexed under Pituitary ACTH Hypersecretion.
Browse Pituitary ACTH Hypersecretion studies →Hospices Civils de Lyon is the lead sponsor of 1,866 studies on the registry; 448 are open to participants now.
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Adults treated at a tertiary academic hospital with biochemically confirmed Cushing's disease, evaluated by pituitary MRI and [18F]FET PET as part of diagnostic work-up, and discussed for surgery.
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Exclusion Criteria:
Adults (≥18 years) with biochemically confirmed Cushing's disease with negative or doubtlful or microadenoma on pituitary MRI and are discussed for surgical management; who benefited from a\[18F\]FET PET in their clinical work-up.
Other: Data-only evaluation of [18F]FET PET, pituitary MRI, and biomarkers
No study-specific procedures. The study evaluates existing \[18F\]FET PET imaging pituitary MRI, and routine biochemical markers collected as part of standard care.
[18F]FET PET Performance for Localizing Corticotroph Pituitary Adenomas
Proportion (%) of correct localization of the adenoma by \[18F\]FET PET, using postoperative histopathological examination of the surgical specimen as the reference standard.
Time frame: 3 months
Effect of PET on Tumor Localization Versus MRI
Among cases in which the PET-suggested localization differs from MRI, the proportion (%) in which PET correctly localizes the adenoma (per the primary endpoint definition).
Time frame: 3 months
Inter-Reader Agreement of [18F]FET PET Interpretation
Proportion (%) agreement between the two nuclear medicine physicians' PET interpretations (inter-reader agreement).
Time frame: 1 month
Correlation Between PET SUV and Hypercortisolism Biomarkers
Correlation between \[18F\]FET PET and biochemical markers
Time frame: 3 months
Determinants of PET Performance (Clinical/Biological/Imaging)
Univariable and multivariable analyses of variables that may influence PET results.
Time frame: 3 months
Prognostic Value of PET Findings for Biological Remission
Correlation between PET results and the patient's biological status at follow-up (biological remission-e.g., corticotroph inertia or normalization of urinary free cortisol (UFC)-versus active hypercortisolism).
Time frame: 3 months
Plan to share: Undecided
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