Impact of [11C]-Methionine PET/MRI in the Detection of Pituitary Adenomas Secreting ACTH and Causing Cushing's Disease (IMPEC)
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|ClinicalTrials.gov Identifier: NCT03346954|
Recruitment Status : Not yet recruiting
First Posted : November 20, 2017
Last Update Posted : November 21, 2017
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
|Condition or disease||Intervention/treatment||Phase|
|Cushing's Disease||Other: [11C]-Methionine PET/MRI||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Impact of [11C]-Methionine PET/MRI in the Detection of Pituitary Adenomas Secreting ACTH and Causing Cushing's Disease|
|Estimated Study Start Date :||December 1, 2017|
|Estimated Primary Completion Date :||April 1, 2018|
|Estimated Study Completion Date :||January 1, 2019|
Experimental: Patients with Cushing's disease
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 [ Time Frame: Within 3 months and 3 weeks after inclusion ]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.
- False negatives and false positives description [ Time Frame: Within 3 months and 3 weeks after inclusion ]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
- Description of identified microadenomas [ Time Frame: Within 3 months and 3 weeks months after inclusion ]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.
- Comparison of [11C]-Methionine PET/MRI and pituitary MRI [ Time Frame: Within 3 months and 3 weeks months after inclusion ]Study of the concordance between the results of [11C]-Methionine PET/MRI and pituitary MRI
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03346954
|Contact: BOURNAUD Claire, MD||+33 4 27 35 72 firstname.lastname@example.org|
|Contact: LEVIGOUREUX Elise, PharmD||+33 4 27 85 54 email@example.com|
|Service de Médecine Nucléaire - Hospices Civils de Lyon||Not yet recruiting|
|Bron, France, 69677|
|Contact: BOURNAUD claire, MD +33 4 27 35 72 81 firstname.lastname@example.org|
|Contact: LEVIGOUREUX Elise, PharmD +33 4 27 85 54 72 email@example.com|
|Study Director:||BOURNAUD Claire, MD||Hospices Civils de Lyon|