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Clinical Trial NCT07463625 (PiTFET) for Cushing Disease, ACTH-producing Pituitary Tumour is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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Evaluation of Positron Emission Tomography (PET) With [18F]FET for the Detection of ACTH-Secreting Corticotroph Pituitary Neuroendocrine Tumors. (PiTFET) 20 Observational
Clinical Trial NCT07463625 (PiTFET) is an observational study for Cushing Disease, ACTH-producing Pituitary Tumour that is recruiting. It started on 23 November 2023 with plans to enroll 20 participants. Led by Hospices Civils de Lyon, it is expected to complete by 23 November 2028. The latest data from ClinicalTrials.gov was last updated on 11 March 2026.
Brief 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 \[18F\]fluoroethy...
Show MoreOfficial Title
Evaluation of [18F]FET PET for the Detection of ACTH-Secreting Corticotroph Pituitary Neuroendocrine Tumors
Conditions
Cushing DiseaseACTH-producing Pituitary TumourOther Study IDs
- PiTFET
- 25-5027
NCT ID Number
Start Date (Actual)
2023-11-23
Last Update Posted
2026-03-11
Completion Date (Estimated)
2028-11-23
Enrollment (Estimated)
20
Study Type
Observational
Status
Recruiting
Keywords
PET
Cushing disease
[18F]FET
PitNET
Corticotroph adenoma
ACTH
Pituitary
MRI
Amino-acid
Cushing disease
[18F]FET
PitNET
Corticotroph adenoma
ACTH
Pituitary
MRI
Amino-acid
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
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. | 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
Secondary Outcome Measures
| Outcome Measure | 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 |
| Outcome Measure | 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 | 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 |
Participation Assistant
Eligibility Criteria
Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
- 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.
- Minor (age <18 years).
- Macroadenoma of the pituitary.
- ACTH-dependent hypercortisolism secondary to ectopic secretion.
Hospices Civils de LyonStudy Central Contact
Contact: Anthime FLAUS, MD, +33 4 72 35 69 99, [email protected]
1 Study Locations in 1 Countries
Hôpital Louis Pradel - Service de Médecine Nucléaire, Bron, 69500, France
Recruiting