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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adults with Cushing's disease evaluated for pituitary surgery | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Data-only evaluation of [18F]FET PET, pituitary MRI, and biomarkers | Other | No study-specific procedures. The study evaluates existing [18F]FET PET imaging pituitary MRI, and routine biochemical markers collected as part of standard care. |
| Measure | Description | Time Frame |
|---|---|---|
| [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. | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 3 months |
| Inter-Reader Agreement of [18F]FET PET Interpretation |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Anthime FLAUS, MD | Contact | +33 4 72 35 69 99 | anthime.flaus@chu-lyon.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Louis Pradel - Service de Médecine Nucléaire | Recruiting | Bron | 69500 | France |
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Proportion (%) agreement between the two nuclear medicine physicians' PET interpretations (inter-reader agreement). |
| 1 month |
| Correlation Between PET SUV and Hypercortisolism Biomarkers | Correlation between [18F]FET PET and biochemical markers | 3 months |
| Determinants of PET Performance (Clinical/Biological/Imaging) | Univariable and multivariable analyses of variables that may influence PET results. | 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). | 3 months |
| ID | Term |
|---|---|
| D047748 | Pituitary ACTH Hypersecretion |
| D049913 | ACTH-Secreting Pituitary Adenoma |
| D010900 | Pituitary Diseases |
| ID | Term |
|---|---|
| D006964 | Hyperpituitarism |
| D007027 | Hypothalamic Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D004700 | Endocrine System Diseases |
| D000236 | Adenoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D010911 | Pituitary Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| D015415 | Biomarkers |
| ID | Term |
|---|---|
| D001685 | Biological Factors |
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