NCT07463625 Evaluation of Positron Emission Tomography (PET) With [18F]FET for the Detection of ACTH-Secreting Corticotroph Pituitary Neuroendocrine Tumors.
| NCT ID | NCT07463625 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Hospices Civils de Lyon |
| Condition | Cushing Disease |
| Study Type | OBSERVATIONAL |
| Enrollment | 20 participants |
| Start Date | 2023-11-23 |
| Primary Completion | 2027-11-23 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 20 participants in total. It began in 2023-11-23 with a primary completion date of 2027-11-23.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 \[18F\]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.
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07463625 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Cushing Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07463625 currently recruiting?
Yes, NCT07463625 is actively recruiting participants. Contact the research team at anthime.flaus@chu-lyon.fr for enrollment information.
Where is the NCT07463625 trial being conducted?
This trial is being conducted at Bron, France.
Who is sponsoring the NCT07463625 clinical trial?
NCT07463625 is sponsored by Hospices Civils de Lyon. The trial plans to enroll 20 participants.