NCT07463625

Evaluation of Positron Emission Tomography (PET) With [18F]FET for the Detection of ACTH-Secreting Corticotroph Pituitary Neuroendocrine Tumors.

Evaluation of [18F]FET PET for the Detection of ACTH-Secreting Corticotroph Pituitary Neuroendocrine Tumors

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 20 (estimated)
• Sponsor: Hospices Civils de Lyon · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Cushing Disease
• ACTH-producing Pituitary Tumour

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-11-23
• Primary completion: 2027-11-23
• Completion: 2028-11-23
• First posted: 2026-03-11
• Last updated: 2026-03-11

Locations

1 site across 1 country: France