- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03580837
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 Contact
- Name: Sébastien MOLIERE, MD
- Phone Number: 33 3 88 12 78 65
- Email: sebastien.moliere@chru-strasbourg.fr
Study Contact Backup
- Name: Marie-Noëlle ROEDLICH, MD
- Phone Number: 33 3 88 12 78 65
- Email: marie-noelle.roedlich@chru-strasbourg.fr
Study Locations
-
-
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Strasbourg, France, 67098
- Recruiting
- Service Imagerie 1
-
Contact:
- Sébastien MOLIERE, MD
- Phone Number: 33 3 88 12 78 65
- Email: sebastien.moliere@chru-strasbourg.fr
-
Principal Investigator:
- Sébastien MOLIERE, MD
-
Sub-Investigator:
- Marie-Noëlle ROEDLICH, MD
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Sub-Investigator:
- Isabelle ODDOU, MD
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Contact:
- Marie-Noëlle ROEDLICH, MD
- Phone Number: 33 3 88 12 78 65
- Email: marie-noelle.roedlich@chru-strasbourg.fr
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Sub-Investigator:
- Carole MATHELIN, MD, PhD
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-
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.
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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