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Feasibility Study of Breast MRI in Decubitus Position (EFIMED)

I

Institut de Cancérologie de Lorraine

Status

Completed

Conditions

Breast Cancer

Treatments

Procedure: Position for the 3.0 Tesla in Magnetic Resonance Imaging

Study type

Interventional

Funder types

Other

Identifiers

NCT02865239
2015-A00578-41

Details and patient eligibility

About

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.

Enrollment

15 patients

Sex

Female

Ages

Under 18 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Other

Allocation

Non-Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

15 participants in 2 patient groups, including a placebo group

Supine position
Placebo Comparator group
Description:
3.0 tesla MRI in supine position
Treatment:
Procedure: Position for the 3.0 Tesla in Magnetic Resonance Imaging
Prone position
Active Comparator group
Description:
3.0 tesla MRI in prone position
Treatment:
Procedure: Position for the 3.0 Tesla in Magnetic Resonance Imaging

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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