Clinical trial · Observational
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| ACTH-producing Pituitary Tumour | — | UNRESOLVED | — |
| Cushing Disease | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Data-only evaluation of [18F]FET PET, pituitary MRI, and biomarkers | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Adults with Cushing's disease evaluated for pituitary surgery
- description
- 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.
- interventionNames
- Other: Data-only evaluation of [18F]FET PET, pituitary MRI, and biomarkers
Primary outcomes (1)
- measure
- [18F]FET PET Performance for Localizing Corticotroph Pituitary Adenomas
- timeFrame
- 3 months
- description
- Proportion (%) of correct localization of the adenoma by \[18F\]FET PET, using postoperative histopathological examination of the surgical specimen as the reference standard.
Secondary outcomes (5)
- measure
- Effect of PET on Tumor Localization Versus MRI
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
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