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Clinical Trials/NCT02865239
NCT02865239
Completed
Not Applicable

Feasibility Study of Breast MRI in Decubitus Position

Institut de Cancérologie de Lorraine1 site in 1 country15 target enrollmentJune 25, 2015
ConditionsBreast Cancer

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Breast Cancer
Sponsor
Institut de Cancérologie de Lorraine
Enrollment
15
Locations
1
Primary Endpoint
Percentage of lesions where the topography is discordant between the positions (prone and supine).
Status
Completed
Last Updated
7 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 25, 2015
End Date
August 20, 2015
Last Updated
7 years ago
Study Type
Interventional
Study Design
Crossover
Sex
Female

Investigators

Sponsor
Institut de Cancérologie de Lorraine
Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

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

  • 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)

Study Sites (1)

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