Breast MRI for Neaodjuvant Chemotherapy Response Prediction and Evaluation in Breast Cancer

June 25, 2018 updated by: University Hospital, Strasbourg, France

Breast MRI for Neaodjuvant Chemotherapy Response Prediction and Evaluation in Breast Cancer, With Focus on Background Parenchymal Enhancement

The aim of this retrospective study is to evaluate the value of pre-treatment and post-treatment multimodality MRI study, including quantitative evaluation of background parenchymal enhancement, for response prediction and evaluation. This study will include 100 patients treated in a single institution between 2011 and 2016

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Strasbourg, France, 67098
        • Recruiting
        • Service Imagerie 1
        • Contact:
        • Principal Investigator:
          • Sebastien MOLIERE, MD
        • Sub-Investigator:
          • Marie-Noëlle ROEDLICH, MD
        • Sub-Investigator:
          • Isabelle ODDOU, MD
        • Contact:
        • Sub-Investigator:
          • Carole MATHELIN, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with breast cancer treated with neoadjuvant chemotherapy

Description

Inclusion Criteria:

  • Adult patients
  • Patients with breast cancer treated with neoadjuvant chemotherapy
  • Patients with pre- and post-chemotherapy MRI
  • Patients who have given their agreement to use their data for research purposes.

Exclusion Criteria:

- Refusal to participate in the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Presence or absence of of pathologic enhancement of breast by MRI
Time Frame: 1 hour after the realization of the MRI
This work concerns 110 patients treated with neoadjuvant chemotherapy for breast cancer and having received a breast MRI in pre and post-chemiotherapy at the Hautepierre Hospital.
1 hour after the realization of the MRI

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Strasbourg, France

Investigators

  • Principal Investigator: Sébastien MOLIERE, MD, University Hospital, Strasbourg, France

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2018

Primary Completion (Anticipated)

January 1, 2019

Study Completion (Anticipated)

January 1, 2019

Study Registration Dates

First Submitted

January 3, 2018

First Submitted That Met QC Criteria

June 25, 2018

First Posted (Actual)

July 9, 2018

Study Record Updates

Last Update Posted (Actual)

July 9, 2018

Last Update Submitted That Met QC Criteria

June 25, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 6788

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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