RecruitingNCT07463625

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


Sponsor

Hospices Civils de Lyon

Enrollment

20 participants

Start Date

Nov 23, 2023

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new type of PET scan using a tracer called [18F]FET to help find small tumors in the pituitary gland that cause Cushing's disease — a condition where the body produces too much cortisol (a stress hormone) due to a pituitary tumor. These tumors are often very small and hard to see on regular MRI scans. **You may be eligible if...** - You are 18 years or older - You have a biochemical diagnosis of Cushing's disease (confirmed through blood and urine tests) - You have had a pituitary MRI; if a tumor was found, it is smaller than 10 mm - You are being evaluated for pituitary surgery **You may NOT be eligible if...** - You are under 18 - Your pituitary tumor is larger (a macroadenoma, 10 mm or bigger) - Your high cortisol is coming from a source outside the pituitary (ectopic ACTH secretion) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERData-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.


Locations(1)

Hôpital Louis Pradel - Service de Médecine Nucléaire

Bron, France

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NCT07463625


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