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Feasibility Study of Breast MRI in Decubitus Position

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02865239
Acronym
EFIMED
Enrollment
15
Registered
2016-08-12
Start date
2015-06-25
Completion date
2015-08-20
Last updated
2018-08-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

Imaging, Three-Dimensional, Magnetic Resonance Imaging/methods*, Breast Neoplasms/diagnosis*, Prone Position, Prospective Studies

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.

Interventions

PROCEDUREPosition 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

Sponsors

Institut de Cancérologie de Lorraine
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
No minimum to 18 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Percentage of lesions where the topography is discordant between the positions (prone and supine).1 dayThe 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

MeasureTime frame
distance from lesion to pectoralis major muscle in supine position compared to the prone position1 day
Quandrant of the lesions and positions on a clock in supine position compared to the prone position1 day
Comfort patient in supine position compared to the prone position using a self-administered questionnaire1 day
distance from the anterior border of the lesion to the nipple in supine position compared to the prone position1 day
distance from cutaneous projection of the lesion to the nipple in supine position compared to the prone position1 day

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026