Benefits of Breast MRI for Predicting of Histopathologic Cell Type of Small Breast Cancer
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
2 other identifiers
interventional
60
1 country
1
Brief Summary
This study examines the additional benefits of magnetic resonance imaging (MRI) with Gadovist in early breast cancer with poor prognostic features.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Feb 2011
Typical duration for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2011
CompletedFirst Submitted
Initial submission to the registry
May 13, 2011
CompletedFirst Posted
Study publicly available on registry
May 15, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2013
CompletedJanuary 23, 2013
January 1, 2013
1.4 years
May 13, 2011
January 21, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
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
1 year
Secondary Outcomes (1)
ascertain the accuracy of pre-operative DCE-MRI in terms of detection and characterization of breast cancer, as compared to tissue biopsy.
1 year
Study Arms (1)
No treatment
OTHERAccuracy 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 )
Interventions
magnetic resonance imaging (MRI) with Gadovist in early breast cancer with poor prognostic features
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Faculty of Medicine Siriraj Hospital
Bangkoknoi, Bangkok, 10700, Thailand
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Pornpim Korpraphong, M.D.
Mahidol University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 13, 2011
First Posted
May 15, 2012
Study Start
February 1, 2011
Primary Completion
July 1, 2012
Study Completion
December 1, 2013
Last Updated
January 23, 2013
Record last verified: 2013-01