Back to resultsBenefits of Breast MRI for Predicting of Histopathologic Cell Type of Small Breast Cancer
Primary Purpose
Invasive Breast Cancer
Status
Unknown status
Phase
Phase 4
Locations
Thailand
Study Type
Interventional
Intervention
MRI
Sponsored by
About this trial
This is an interventional diagnostic trial for Invasive Breast Cancer
Eligibility Criteria
Inclusion Criteria:
- Patients with invasive ductal carcinoma
- Patients undergoing DCE-MRI scan which are assessed according to BI-RADS lexicon
- Breast cancer patients with pathological diagnosed invasive ductal carcinoma with hormonal receptor (ER, PR and HER-2) response
- Patients who have signed on informed consent form Patients will undergo MRI imaging and the physicians will practice according to practice guidelines.
Exclusion Criteria:
- Patients under 18 years old or during pregnancy
- Patients with MRI's contraindications e.g. patients with cardiac pacemaker or are allergic to MRI contrast agent Patients with unstable clinical abnormality and might get unexpected clinical treatment
Sites / Locations
- Faculty of Medicine Siriraj HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
No treatment
Arm Description
Accuracy of magnetic resonance imaging (MRI) in predicting aggressiveness of early breast cancer according to molecular subtypes identified by ER PR and HER-2 status ( Additional benefits of magnetic resonance imaging (MRI) with Gadovist in early breast cancer with poor prognostic features )
Outcomes
Primary Outcome Measures
study the benefits of DCE-MRI using Gadovist in prognostic determination of early invasive breast cancer
The benefits of breast tumor diagnosis from DCE-MRI in early invasive breast cancer with poor prognostic features
Secondary Outcome Measures
ascertain the accuracy of pre-operative DCE-MRI in terms of detection and characterization of breast cancer, as compared to tissue biopsy.
The comparision between DCE-MRI radiological features in early invasive breast cancer with poor prognostic features and early invasive breast cancer with good prognostic features To ascertain the accuracy of pre-operative DCE-MRI in terms of detection and charecterization of breast cancer, as compared to tissue biopsy
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01597999
Brief Title
Benefits of Breast MRI for Predicting of Histopathologic Cell Type of Small Breast Cancer
Official Title
Accuracy of Magnetic Resonance Imaging (MRI) in Predicting Aggressiveness of Early Breast Cancer According to Molecular Subtypes Identified by ER PR and HER-2 Status
Study Type
Interventional
2. Study Status
Record Verification Date
January 2013
Overall Recruitment Status
Unknown status
Study Start Date
February 2011 (undefined)
Primary Completion Date
July 2012 (Actual)
Study Completion Date
December 2013 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mahidol University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study examines the additional benefits of magnetic resonance imaging (MRI) with Gadovist in early breast cancer with poor prognostic features.
Detailed Description
Dedicated Contrast-enhanced Magnetic Resonance Imaging (DCE-MRI)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Invasive Breast Cancer
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
No treatment
Arm Type
Other
Arm Description
Accuracy of magnetic resonance imaging (MRI) in predicting aggressiveness of early breast cancer according to molecular subtypes identified by ER PR and HER-2 status ( Additional benefits of magnetic resonance imaging (MRI) with Gadovist in early breast cancer with poor prognostic features )
Intervention Type
Radiation
Intervention Name(s)
MRI
Other Intervention Name(s)
Magnetic Resonance Imaging
Intervention Description
magnetic resonance imaging (MRI) with Gadovist in early breast cancer with poor prognostic features
Primary Outcome Measure Information:
Title
study the benefits of DCE-MRI using Gadovist in prognostic determination of early invasive breast cancer
Description
The benefits of breast tumor diagnosis from DCE-MRI in early invasive breast cancer with poor prognostic features
Time Frame
1 year
Secondary Outcome Measure Information:
Title
ascertain the accuracy of pre-operative DCE-MRI in terms of detection and characterization of breast cancer, as compared to tissue biopsy.
Description
The comparision between DCE-MRI radiological features in early invasive breast cancer with poor prognostic features and early invasive breast cancer with good prognostic features To ascertain the accuracy of pre-operative DCE-MRI in terms of detection and charecterization of breast cancer, as compared to tissue biopsy
Time Frame
1 year
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with invasive ductal carcinoma
Patients undergoing DCE-MRI scan which are assessed according to BI-RADS lexicon
Breast cancer patients with pathological diagnosed invasive ductal carcinoma with hormonal receptor (ER, PR and HER-2) response
Patients who have signed on informed consent form Patients will undergo MRI imaging and the physicians will practice according to practice guidelines.
Exclusion Criteria:
Patients under 18 years old or during pregnancy
Patients with MRI's contraindications e.g. patients with cardiac pacemaker or are allergic to MRI contrast agent Patients with unstable clinical abnormality and might get unexpected clinical treatment
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dr.Pornpim Korpraphong, Assist.Prof.
Phone
6624197000
Ext
9039
Email
pfuang@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pornpim Korpraphong, M.D.
Organizational Affiliation
Mahidol University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of Medicine Siriraj Hospital
City
Bangkoknoi
State/Province
Bangkok
ZIP/Postal Code
10700
Country
Thailand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr.Pornpim Korpraphong, Assist.Prof.
Phone
662-4197000
Ext
9039
Email
pfuang@yahoo.com
First Name & Middle Initial & Last Name & Degree
Dr.Pornpim Korpraphong, Assist.Prof.
12. IPD Sharing Statement
Learn more about this trial
Benefits of Breast MRI for Predicting of Histopathologic Cell Type of Small Breast Cancer
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