Feasibility Study of Breast MRI in Decubitus Position (EFIMED)

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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer
• Intervention / Treatment: Procedure: Position for the 3.0 Tesla in Magnetic Resonance Imaging

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Vandoeuvre-lès-Nancy, France, 54500
    • Institut de Cancerologie de Lorraine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Supine position; 3.0 tesla MRI in supine position	Procedure: Position for the 3.0 Tesla in Magnetic Resonance Imaging; 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
Active Comparator: Prone position; 3.0 tesla MRI in prone position	Procedure: Position for the 3.0 Tesla in Magnetic Resonance Imaging; 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

What is the study measuring?

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	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

Collaborators and Investigators

• Sponsor: Institut de Cancérologie de Lorraine
• Investigators: Principal Investigator: OLDRINI Guillaume, MD, Institut de Cancerologie de Lorraine

Study record dates

Study Major Dates

• Study Start (Actual): June 25, 2015
• Primary Completion (Actual): August 20, 2015
• Study Completion (Actual): August 20, 2015

Study Registration Dates

• First Submitted: July 5, 2016
• First Submitted That Met QC Criteria: August 9, 2016
• First Posted (Estimate): August 12, 2016

Study Record Updates

• Last Update Posted (Actual): August 8, 2018
• Last Update Submitted That Met QC Criteria: August 7, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Keywords: Prospective Studies; Prone Position; Imaging, Three-Dimensional; Magnetic Resonance Imaging/methods*; Breast Neoplasms/diagnosis*
• Other Study ID Numbers: 2015-A00578-41

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No