An interventional study of [11C]-Methionine PET/MRI in Cushing's Disease, sponsored by Hospices Civils de Lyon. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-09-25.
Sponsored by Hospices Civils de Lyon · Not applicable, Interventional, and Diagnostic
Cushing's disease is characterized by the existence of a benign pituitary tumor developed from corticotropic cells responsible for excessive ACTH secretion. This results in hypercorticism causing high morbidity and mortality and severely impairing quality of life. The etiological diagnosis is based on Magnetic Resonance Imaging (MRI). However, pituitary MRI revealed a pituitary tumor in only 60% of patients. The diagnostic procedure is complicated by the existence of extra pituitary tumors responsible for ACTH ectopic secretion. This rare etiology imposes, in the absence of typical pituitary image, the realization of catheterization of the lower petrosal sinuses. Treatment of Cushing's disease is based on transsphenoidal surgical management, even in the absence of a formal MRI image, if pituitary origin is confirmed by the catheterization. Although pituitary surgery without identified target is part of French recommendations, this surgery is associated with a high risk of failure and morbidity. Optimization of the management of patients' with Cushing's disease thus requires the improvement of the diagnostic methods.
Hypothesis of our study is that [11C] MET MRI-PET may be performed as a first-line MRI for suspected Cushing's disease and may limit indications for catheterization of lower petrosal sinuses. Its localizing value should also make it possible to improve the surgical results with a better identification of the adenoma
64 studies on the registry are indexed under Pituitary ACTH Hypersecretion; 16 are open to participants now.
This study's enrollment of 33 is below the median of 44 across 40 interventional studies indexed under Pituitary ACTH Hypersecretion.
Browse Pituitary ACTH Hypersecretion studies →Hospices Civils de Lyon is the lead sponsor of 1,866 studies on the registry; 448 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
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Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
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Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Implementation of \[11C\]-Methionine PET/MRI
Other: [11C]-Methionine PET/MRI
Implementation \[11C\]-Methionine PET/MRI performed for each patient in one place (department of nuclear medicine of the Hospices Civils de Lyon). The \[11C\]-Methionine PET/MRI will be performed after a pituitary MRI and before a transsphenoidal surgery.
Sensitivity of [11C]-Methionine PET/MRI
Sensitivity of \[11C\]-Methionine PET/MRI to correctly localizes the pituitary corticotropic adenoma in comparison with the sensitivity of the pituitary MRI. The gold standard being the localization defined by anatomopathological analysis on operative resection.
Time frame: Within 3 months and 3 weeks after inclusion
False negatives and false positives description
Description of false negatives and false positives \[11C\]-Methionine PET/MRI to identify and localize the microadenoma. Characteristics of unidentified adenomas will be described using: volume, localization, type of fixation
Time frame: Within 3 months and 3 weeks after inclusion
Description of identified microadenomas
Proportion of microadenomas identified by the \[11C\]-Methionine PET/MRI as a function of the degree of aggressiveness of the adenoma, evaluated by the number of mitoses, the level of expression of Ki67 and p53.
Time frame: Within 3 months and 3 weeks months after inclusion
Comparison of [11C]-Methionine PET/MRI and pituitary MRI
Study of the concordance between the results of \[11C\]-Methionine PET/MRI and pituitary MRI
Time frame: Within 3 months and 3 weeks months after inclusion
Plan to share: No
Ran from Dec 2017 to primary completion in Jun 2019, 18 months.
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This study is completed, as verified in Nov 2020. You cannot join it, but the record below documents what was studied.
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