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NCT04914494 Clinical Trial

Cancer Predictive Score on Breast MRI

Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data
NCT number NCT04914494
Other study ID # RECHMPL21_0379
Secondary ID
Status Enrolling by invitation
Phase
First received
Last updated
Start date January 1, 2021
Est. completion date September 30, 2022

Study information
Verified date January 2022
Source University Hospital, Montpellier
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Enrolling by invitation
Enrollment 428
Est. completion date September 30, 2022
Est. primary completion date December 1, 2021
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility Inclusion criteria: - women aged 18 and more - performed MRI-guided breast biopsy Exclusion criteria: - Not MRI-guided breast biopsy

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
France Uhmontpellier Montpellier

Sponsors (1)
Lead Sponsor Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of participants with MRI characteristics of breast lesions MRI characteristics of breast lesions :
shape, contours, size, enhancement, perileeal edema, enhancement curve		 1 day
Secondary predictive score for the benignity of lesions seen on MRI 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.		 1 day
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