Feasibility Study of Breast MRI in Decubitus Position

Not Applicable

Completed

• Conditions: Breast Cancer
• Interventions: Procedure: Position for the 3.0 Tesla in Magnetic Resonance Imaging

• Registration Number: NCT02865239
• Lead Sponsor: Institut de Cancérologie de Lorraine

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-06-25
• Primary Completion: 2015-08-20
• Study Completion: 2015-08-20
• Study First Submitted: 2016-07-05
• Study First Submitted QC: 2016-08-09
• Study First Posted: 2016-08-12
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-07
• Last Update Posted: 2018-08-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 15

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Supine position	Position for the 3.0 Tesla in Magnetic Resonance Imaging	3.0 tesla MRI in supine position
Prone position	Position for the 3.0 Tesla in Magnetic Resonance Imaging	3.0 tesla MRI in prone position

Primary Outcome Measures

Name	Time	Method
Percentage of lesions where the topography is discordant between the positions (prone and supine).	1 day	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.

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Institut de Cancérologie de Lorraine; 🇫🇷 Vandoeuvre-lès-Nancy, France