NCT02865239

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable breast-cancer

Timeline
Completed

Started Jun 2015

Shorter than P25 for not_applicable breast-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 25, 2015

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 20, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 20, 2015

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

July 5, 2016

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 12, 2016

Completed
Last Updated

August 8, 2018

Status Verified

August 1, 2018

Enrollment Period

2 months

First QC Date

July 5, 2016

Last Update Submit

August 7, 2018

Conditions

Breast Cancer

Keywords

Imaging, Three-DimensionalMagnetic Resonance Imaging/methods*Breast Neoplasms/diagnosis*Prone PositionProspective Studies

Outcome Measures

Primary Outcomes (1)

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

    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.

    1 day

Secondary Outcomes (5)

  • 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 Arms (2)

Supine position

PLACEBO COMPARATOR

3.0 tesla MRI in supine position

Procedure: Position for the 3.0 Tesla in Magnetic Resonance Imaging

Prone position

ACTIVE COMPARATOR

3.0 tesla MRI in prone position

Procedure: Position for the 3.0 Tesla in Magnetic Resonance Imaging

Interventions

Position for the 3.0 Tesla in Magnetic Resonance ImagingPROCEDURE

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 positionSupine position

Eligibility Criteria

AgeUp to 18 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Age \< 18 years old
  • Claustrophobia
  • Contraindication to the injection of contrast medium Gadoline
  • Contraindication to MRI
  • Persons deprived of liberty or under supervision

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institut de Cancérologie de Lorraine

Vandœuvre-lès-Nancy, 54500, France

Location

MeSH Terms

Conditions

Breast NeoplasmsDisease

Interventions

Patient PositioningMagnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Patient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and ServicesSpectrum AnalysisChemistry Techniques, AnalyticalInvestigative Techniques

Study Officials

  • OLDRINI GUILLAUME, MD

    Institut de Cancérologie de Lorraine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 5, 2016

First Posted

August 12, 2016

Study Start

June 25, 2015

Primary Completion

August 20, 2015

Study Completion

August 20, 2015

Last Updated

August 8, 2018

Record last verified: 2018-08

Locations

FR(1)