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Benefits of Breast MRI for Predicting of Histopathologic Cell Type of Small Breast Cancer

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ClinicalTrials.gov Identifier: NCT01597999
Recruitment Status : Unknown
Verified January 2013 by Mahidol University.
Recruitment status was:  Recruiting
First Posted : May 15, 2012
Last Update Posted : January 23, 2013
Sponsor:
Information provided by (Responsible Party):
Mahidol University

Study Description
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Brief Summary:
This study examines the additional benefits of magnetic resonance imaging (MRI) with Gadovist in early breast cancer with poor prognostic features.

Condition or disease Intervention/treatment Phase
Invasive Breast Cancer Radiation: MRI Phase 4

Detailed Description:
Dedicated Contrast-enhanced Magnetic Resonance Imaging (DCE-MRI)
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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 Start Date : February 2011
Actual Primary Completion Date : July 2012
Estimated Study Completion Date : December 2013

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Arms and Interventions
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Arm Intervention/treatment
No treatment
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 )
 Radiation: MRI
magnetic resonance imaging (MRI) with Gadovist in early breast cancer with poor prognostic features
Other Name: Magnetic Resonance Imaging


Outcome Measures
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Primary Outcome Measures :
  1. study the benefits of DCE-MRI using Gadovist in prognostic determination of early invasive breast cancer [ Time Frame: 1 year ]
    The benefits of breast tumor diagnosis from DCE-MRI in early invasive breast cancer with poor prognostic features


Secondary Outcome Measures :
  1. ascertain the accuracy of pre-operative DCE-MRI in terms of detection and characterization of breast cancer, as compared to tissue biopsy. [ Time Frame: 1 year ]
    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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01597999


Contacts
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Contact: Dr.Pornpim Korpraphong, Assist.Prof. 6624197000 ext 9039 pfuang@yahoo.com

Locations
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Thailand
Faculty of Medicine Siriraj Hospital Recruiting
Bangkoknoi, Bangkok, Thailand, 10700
Contact: Dr.Pornpim Korpraphong, Assist.Prof.    662-4197000 ext 9039    pfuang@yahoo.com   
Principal Investigator: Dr.Pornpim Korpraphong, Assist.Prof.         
Sponsors and Collaborators
Mahidol University
Investigators
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Principal Investigator: Pornpim Korpraphong, M.D. Mahidol University
More Information
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Responsible Party: Mahidol University
ClinicalTrials.gov Identifier: NCT01597999    
Other Study ID Numbers: 15262
578/2533(EC4) ( Other Identifier: IRB )
First Posted: May 15, 2012    Key Record Dates
Last Update Posted: January 23, 2013
Last Verified: January 2013
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases