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

This study is currently recruiting participants.
Verified January 2013 by Mahidol University
Sponsor:
Information provided by (Responsible Party):
Mahidol University
ClinicalTrials.gov Identifier:
NCT01597999
First received: May 13, 2011
Last updated: January 21, 2013
Last verified: January 2013
History of Changes
  Purpose

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


Condition Intervention Phase
Invasive Breast Cancer
 Radiation: MRI
 Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Mahidol University:

Primary Outcome Measures:
  • study the benefits of DCE-MRI using Gadovist in prognostic determination of early invasive breast cancer [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 60
Study Start Date: February 2011
Estimated Study Completion Date: December 2013
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

Detailed Description:

Dedicated Contrast-enhanced Magnetic Resonance Imaging (DCE-MRI)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01597999

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

Locations
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
Principal Investigator: Pornpim Korpraphong, M.D. Mahidol University
  More Information

No publications provided

Responsible Party: Mahidol University
ClinicalTrials.gov Identifier: NCT01597999     History of Changes
Other Study ID Numbers: 15262, 578/2533(EC4)
Study First Received: May 13, 2011
Last Updated: January 21, 2013
Health Authority: Thailand: Ethical Committee

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on May 19, 2013