Feasibility Study of Breast MRI in Decubitus Position

NCT ID: NCT02865239

Last Updated: 2018-08-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-06-25

Study Completion Date

2015-08-20

Brief Summary

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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

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Conditions

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Breast Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Supine position

3.0 tesla MRI in supine position

Group Type PLACEBO_COMPARATOR

Position for the 3.0 Tesla in Magnetic Resonance Imaging

Intervention Type PROCEDURE

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

Prone position

3.0 tesla MRI in prone position

Group Type ACTIVE_COMPARATOR

Position for the 3.0 Tesla in Magnetic Resonance Imaging

Intervention Type PROCEDURE

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

Interventions

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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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Maximum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Institut de Cancérologie de Lorraine

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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OLDRINI GUILLAUME, MD

Role: PRINCIPAL_INVESTIGATOR

Institut de Cancérologie de Lorraine

Locations

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Institut de Cancérologie de Lorraine

Vandœuvre-lès-Nancy, , France

Site Status

Countries

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France

Other Identifiers

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2015-A00578-41

Identifier Type: -

Identifier Source: org_study_id

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