NCT04914494

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
428

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2021

Geographic Reach
1 country

1 active site

Status
unknown

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

January 1, 2021

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

June 2, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 4, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2022

Completed
Last Updated

January 26, 2022

Status Verified

January 1, 2022

Enrollment Period

11 months

First QC Date

June 2, 2021

Last Update Submit

January 10, 2022

Conditions

Breast Cancer

Keywords

Women imagingDiagnostic ImagingMagnetic Resonance ImagingBreast biopsyBreast cancer detectionpredictive factorsRadiologyBreast lesion diagnosis

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • predictive score for the benignity of lesions seen on MRI

    1 day

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Women aged 18 to 50 years old

You may qualify if:

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

You may not qualify if:

  • \- Not MRI-guided breast biopsy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Uhmontpellier

Montpellier, 34295, France

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Patrice TAOUREL, MD.PhD

    University Hospital, Montpellier

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 2, 2021

First Posted

June 4, 2021

Study Start

January 1, 2021

Primary Completion

December 1, 2021

Study Completion

September 30, 2022

Last Updated

January 26, 2022

Record last verified: 2022-01

Locations

FR(1)