Cancer Predictive Score on Breast MRI

Sponsor

University Hospital, Montpellier (Other)

Overall Status

Enrolling by invitation

CT.gov ID

NCT04914494

Collaborator

(none)

428

Enrollment

Location

20.9

Anticipated Duration (Months)

20.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Sometimes, breast ultrasound and mammographic can't be diagnose suspsious lesions ( no substratum). So a MRI-guided breast biopsy is perfomed and disclosed ultimately benign lesions.

The aim of this retrospective study is to establish a predictive MRI score of occult breast lesions by mammography and ultrasound.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer

Study Design

Study Type:

Observational

Anticipated Enrollment :

428 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

Malignity Predictive Factors on Breast MRI With Ultrasound and Mammography Occult Lesions

Actual Study Start Date :

Jan 1, 2021

Actual Primary Completion Date :

Dec 1, 2021

Anticipated Study Completion Date :

Sep 30, 2022

Outcome Measures

Primary Outcome Measures

Number of participants with MRI characteristics of breast lesions [1 day]
MRI characteristics of breast lesions : shape, contours, size, enhancement, perileeal edema, enhancement curve

Secondary Outcome Measures

predictive score for the benignity of lesions seen on MRI [1 day]
predictive score for the benignity of lesions seen on MRI (and not on mammography and ultrasound) with the criteria which will emerge after multivariate analysis and which will be weighted . score out of 10, with 3 to 5 criteria rated from 0 to 2. 10 would be in favor of benignity and 0 in favor of malignancy.