Impact of [11C]-Methionine PET/MRI in the Detection of Pituitary Adenomas Secreting ACTH and Causing Cushing's Disease (IMPEC)
Primary Purpose
Cushing's Disease
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
[11C]-Methionine PET/MRI
Sponsored by
About this trial
This is an interventional diagnostic trial for Cushing's Disease focused on measuring : Cushing's disease, [11C]-Methionine PET/MRI, Sensitivity
Eligibility Criteria
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.
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
Sites / Locations
- Service de Médecine Nucléaire - Hospices Civils de Lyon
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Patients with Cushing's disease
Arm Description
Implementation of [11C]-Methionine PET/MRI
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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
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.
Comparison of [11C]-Methionine PET/MRI and pituitary MRI
Study of the concordance between the results of [11C]-Methionine PET/MRI and pituitary MRI
Full Information
NCT ID
NCT03346954
First Posted
November 15, 2017
Last Updated
November 30, 2020
Sponsor
Hospices Civils de Lyon
1. Study Identification
Unique Protocol Identification Number
NCT03346954
Brief Title
Impact of [11C]-Methionine PET/MRI in the Detection of Pituitary Adenomas Secreting ACTH and Causing Cushing's Disease
Acronym
IMPEC
Official Title
Impact of [11C]-Methionine PET/MRI in the Detection of Pituitary Adenomas Secreting ACTH and Causing Cushing's Disease
Study Type
Interventional
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
December 11, 2017 (Actual)
Primary Completion Date
June 11, 2019 (Actual)
Study Completion Date
August 31, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cushing's Disease
Keywords
: Cushing's disease, [11C]-Methionine PET/MRI, Sensitivity
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
33 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Patients with Cushing's disease
Arm Type
Experimental
Arm Description
Implementation of [11C]-Methionine PET/MRI
Intervention Type
Other
Intervention Name(s)
[11C]-Methionine PET/MRI
Intervention Description
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.
Primary Outcome Measure Information:
Title
Sensitivity of [11C]-Methionine PET/MRI
Description
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
Secondary Outcome Measure Information:
Title
False negatives and false positives description
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
Title
Description of identified microadenomas
Description
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
Title
Comparison of [11C]-Methionine PET/MRI and pituitary MRI
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
BOURNAUD Claire, MD
Organizational Affiliation
Hospices Civils de Lyon
Official's Role
Study Director
Facility Information:
Facility Name
Service de Médecine Nucléaire - Hospices Civils de Lyon
City
Bron
ZIP/Postal Code
69677
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Impact of [11C]-Methionine PET/MRI in the Detection of Pituitary Adenomas Secreting ACTH and Causing Cushing's Disease
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