Evaluation of Positron Emission Tomography (PET) With [18F]FET for the Detection of ACTH-Secreting Corticotroph Pituitary Neuroendocrine Tumors.
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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: Data-only evaluation of [18F]FET PET, pituitary MRI, and biomarkers.
- Who it may be relevant to
- Registry conditions: Cushing Disease, ACTH-producing Pituitary Tumour. 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
- France
- 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
Evaluation of [18F]FET PET for the Detection of ACTH-Secreting Corticotroph Pituitary Neuroendocrine Tumors
Overview
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: 1. assessing cases in which PET modifies localization relative to MRI and is correct by gold standard; 2. inter-reader agreement between two nuclear medicine physicians; 3. correlations between PET signal and biochemical markers of hypercortisolism 4. uni- and multivariable analyses of clinical and imaging parameters influencing PET results; 5. association between PET findings and subsequent biological remission.
Interventions
- 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.
Primary outcome measures
- [18F]FET PET Performance for Localizing Corticotroph Pituitary Adenomas [Time frame: 3 months]
Secondary outcome measures (5)
- Effect of PET on Tumor Localization Versus MRI [Time frame: 3 months]
- Inter-Reader Agreement of [18F]FET PET Interpretation [Time frame: 1 month]
- Correlation Between PET SUV and Hypercortisolism Biomarkers [Time frame: 3 months]
- Determinants of PET Performance (Clinical/Biological/Imaging) [Time frame: 3 months]
- Prognostic Value of PET Findings for Biological Remission [Time frame: 3 months]
Eligibility criteria
Inclusion criteria
- Adults (≥18 years).
- Biochemical diagnosis of Cushing's disease as part of initial management.
- Pituitary MRI performed; if visible, microadenoma <10 mm in diameter.
- Indication for discussion in multidisciplinary tumor board for surgical management.
Exclusion criteria
- Minor (age <18 years).
- Macroadenoma of the pituitary.
- ACTH-dependent hypercortisolism secondary to ectopic secretion.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
France · 1 center
- Hôpital Louis Pradel - Service de Médecine Nucléaire — Bron
Identifiers
NCT: NCT07463625 · 25-5027