Cancer Predictive Score on Breast MRI

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

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Breast Cancer

• Study Type: Observational
• Enrollment (Anticipated): 428

Contacts and Locations

Study Locations

• France
  • Montpellier, France, 34295
    • Uhmontpellier

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Women aged 18 to 50 years old

Description

Inclusion criteria:

• women aged 18 and more
• performed MRI-guided breast biopsy

Exclusion criteria:

- Not MRI-guided breast biopsy

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University Hospital, Montpellier
• Investigators: Principal Investigator: Patrice TAOUREL, MD.PhD, University Hospital, Montpellier

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2021
• Primary Completion (Actual): December 1, 2021
• Study Completion (Anticipated): September 30, 2022

Study Registration Dates

• First Submitted: June 2, 2021
• First Submitted That Met QC Criteria: June 2, 2021
• First Posted (Actual): June 4, 2021

Study Record Updates

• Last Update Posted (Actual): January 26, 2022
• Last Update Submitted That Met QC Criteria: January 10, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: Breast cancer detection; Magnetic Resonance Imaging; Radiology; Diagnostic Imaging; Breast biopsy; predictive factors; Women imaging; Breast lesion diagnosis
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: RECHMPL21_0379

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: NC

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No