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

Recruiting now

Conditions studied: Cushing Disease, ACTH-producing Pituitary Tumour

In brief

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.

Key facts

Study ID

NCT07463625

Run by

Hospices Civils de Lyon

People needed

20

Starts

2023-11-23

Expected to finish

2028-11-23

Last updated by the study team

2026-03-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• Minor (age <18 years).
• Macroadenoma of the pituitary.
• ACTH-dependent hypercortisolism secondary to ectopic secretion.

Where it is running

• Hôpital Louis Pradel - Service de Médecine Nucléaire — Bron, France (enrolling)

Full record on ClinicalTrials.gov

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