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Completed

NCT Number: NCT02865239

Feasibility Study of Breast MRI in Decubitus Position

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Disease Neoplasms Neoplasms by Site Pathologic Processes Pathological Conditions, Signs and Symptoms Skin Diseases Skin and Connective Tissue Diseases

Age range

Up to 18 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Institut de Cancérologie de Lorraine

Vandœuvre-lès-Nancy, 54500, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Position for the 3.0 Tesla in Magnetic Resonance Imaging

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

Primary outcomes

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

    Time frame: 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 outcomes

  1. Comfort patient in supine position compared to the prone position using a self-administered questionnaire

    Time frame: 1 day

  2. distance from the anterior border of the lesion to the nipple in supine position compared to the prone position

    Time frame: 1 day

  3. distance from cutaneous projection of the lesion to the nipple in supine position compared to the prone position

    Time frame: 1 day

  4. distance from lesion to pectoralis major muscle in supine position compared to the prone position

    Time frame: 1 day

  5. Quandrant of the lesions and positions on a clock in supine position compared to the prone position

    Time frame: 1 day

Sponsors and collaborators

Lead sponsor

Institut de Cancérologie de Lorraine

Other

Registry information

Acronym: EFIMED

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Aug 12, 2016
Registry last updated
Aug 8, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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