Feasibility Study of Breast MRI in Decubitus Position (EFIMED)

Institut de Cancérologie de Lorraine

Status: Completed

Conditions: Breast Cancer

Treatments: Procedure: Position for the 3.0 Tesla in Magnetic Resonance Imaging

Study type: Interventional

Funder types: Other

Identifiers

NCT02865239

2015-A00578-41

Details and patient eligibility

About

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.

Enrollment: 15 patients

Sex: Female

Ages: Under 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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15 participants in 2 patient groups, including a placebo group

Supine position

Placebo Comparator group

Description:

3.0 tesla MRI in supine position

Treatment:

Procedure: Position for the 3.0 Tesla in Magnetic Resonance Imaging

Prone position

Active Comparator group

Description:

3.0 tesla MRI in prone position

Treatment:

Procedure: Position for the 3.0 Tesla in Magnetic Resonance Imaging