Impact of [11C]-Methionine PET/MRI in the Detection of Pituitary Adenomas Secreting ACTH and Causing Cushing's Disease

Not Applicable

Completed

• Conditions: Cushing's Disease
• Interventions: Other: [11C]-Methionine PET/MRI

• Registration Number: NCT03346954
• Lead Sponsor: Hospices Civils de Lyon

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-11-15
• Study First Submitted QC: 2017-11-15
• Study First Posted: 2017-11-20
• Study Start: 2017-12-11
• Primary Completion: 2019-06-11
• Study Completion: 2020-08-31
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-30
• Last Update Posted: 2020-12-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33

Inclusion Criteria

• Aged 18 years old or over
• Patient with a diagnosed Cushing's disease according to the French "protocole national de diagnostic et de soins (PNDS)"
• Patient who underwent a MRI pituitary for diagnostic purposes
• Patient who have undergone catheterization of the lower petrosal sinuses (if MRI does not detect pituitary adenoma) and have a result in favor of a central secretion of ACTH
• Patient having an indication of surgical excision of the adenoma
• Patient with a micro-adenoma (less than 1 cm in diameter) if the tumor is visualized on MRI
• Patient for which informed and written consent to participate has been obtained.

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Exclusion Criteria

• • Patient participating in another study
• Patient with a pituitary macro-adenoma with visual impairment
• Patient with ACTH-dependent Cushing's syndrome secondary to ectopic ACTH secretion
• Patient with recurrence and / or history of pituitary adenoma excision
• Patient with a contraindication to pituitary surgery or general anesthesia
• Pregnant woman, breastfeeding or old enough to have children but without effective recognized contraception
• Contra-indication to the realization of an MRI: permanently fixed metal parts (pacemaker, cerebral clip, cephalic end piercing, cochlear implant, pin or screw for recent bone fracture, dental equipment, metal splinters), claustrophobia

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients with Cushing's disease	[11C]-Methionine PET/MRI	Implementation of \[11C\]-Methionine PET/MRI

Primary Outcome Measures

Name	Time	Method
Sensitivity of [11C]-Methionine PET/MRI	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.

Secondary Outcome Measures

Name	Time	Method
False negatives and false positives description	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	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	Within 3 months and 3 weeks months after inclusion	Study of the concordance between the results of \[11C\]-Methionine PET/MRI and pituitary MRI

Trial Locations

Locations (1)

Service de Médecine Nucléaire - Hospices Civils de Lyon; 🇫🇷 Bron, France