Feasibility Study of Breast MRI in Decubitus Position

Study Overview
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Brief Summary
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Breast MRI is performed in prone position which causes a number of questions. Indeed, the correlation with mammography and echography and the identification of preoperative lesions can be complex as echography and surgery are carried in supine position while mammography is performed in standing position. Moreover, the prone position is often considered as uncomfortable by the patients. However, there is few publications in the literature on breast MRI in decubitus position.

Conditions
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Breast Cancer

Intervention / Treatment
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* Procedure: Position for the 3.0 Tesla in Magnetic Resonance Imaging


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient to benefit a MRI in the assessment for a breast carcinoma or a suspicious of breast carcinoma Assessment on 3.0 Tesla in Magnetic Resonance Imaging Age >18 years old ECOG performance status ≤ 3 Ability to provide written informed consent form Exclusion Criteria: Age < 18 years old Claustrophobia Contraindication to the injection of contrast medium Gadoline Contraindication to MRI Persons deprived of liberty or under supervision

Ages Eligible for Study
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Maximum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Supine position<br>3.0 tesla MRI in supine position | Procedure: Position for the 3.0 Tesla in Magnetic Resonance Imaging<br>* Eligible patients will have a standard MRI in prone position. At the end of this examination, all patients will have an other standard MRI in supine position. This examination is then extended by 10 minutes without additional injection of contrast medium<br>|
| Active Comparator: Prone position<br>3.0 tesla MRI in prone position | Procedure: Position for the 3.0 Tesla in Magnetic Resonance Imaging<br>* Eligible patients will have a standard MRI in prone position. At the end of this examination, all patients will have an other standard MRI in supine position. This examination is then extended by 10 minutes without additional injection of contrast medium<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of lesions where the topography is discordant between the positions (prone and supine). | The topography is considered discordant if the location of the lesion is different between prone and supine positions (location will be described as the positions on a clock) and / or the distance from the nipple to the lesion is greater than 2cm between prone and supine positions. | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comfort patient in supine position compared to the prone position using a self-administered questionnaire |  | 1 day | 
| distance from the anterior border of the lesion to the nipple in supine position compared to the prone position |  | 1 day | 
| distance from cutaneous projection of the lesion to the nipple in supine position compared to the prone position |  | 1 day | 
| distance from lesion to pectoralis major muscle in supine position compared to the prone position |  | 1 day | 
| Quandrant of the lesions and positions on a clock in supine position compared to the prone position |  | 1 day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Imaging, Three-Dimensional, Magnetic Resonance Imaging/methods*, Breast Neoplasms/diagnosis*, Prone Position, Prospective Studies