Feasibility Study of Breast MRI in Decubitus Position

Breast Cancer Clinical Trial

— EFIMED  

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02865239
• Other study ID #: 2015-A00578-41
• Status: Completed
• Phase: N/A
• Start date: June 25, 2015
• Est. completion date: August 20, 2015

Study information

• Verified date: August 2018
• Source: Institut de Cancérologie de Lorraine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: August 20, 2015
• Est. primary completion date: August 20, 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer

Intervention

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

Locations

Country	Name	City	State
France	Institut de Cancérologie de Lorraine	Vandoeuvre-lès-Nancy

Sponsors (1)

Lead Sponsor	Collaborator
Institut de Cancérologie de Lorraine

Country where clinical trial is conducted

France, 

Outcome

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