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

Tracking Information

First Received Date ^ICMJE

May 13, 2011

Last Updated Date

January 21, 2013

Start Date ^ICMJE

February 2011

Primary Completion Date

July 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01597999 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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)

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic

Condition ^ICMJE

Invasive Breast Cancer

Intervention ^ICMJE

Radiation: MRI

magnetic resonance imaging (MRI) with Gadovist in early breast cancer with poor prognostic features

Other Name: Magnetic Resonance Imaging

Study Arm (s)

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 )

Intervention: Radiation: MRI

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

December 2013

Primary Completion Date

July 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Female

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Dr.Pornpim Korpraphong, Assist.Prof.

6624197000 ext 9039

pfuang@yahoo.com

Location Countries ^ICMJE

Thailand

Administrative Information

NCT Number ^ICMJE

NCT01597999

Other Study ID Numbers ^ICMJE

15262, 578/2533(EC4)

Has Data Monitoring Committee

Responsible Party

Mahidol University

Study Sponsor ^ICMJE

Mahidol University

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Pornpim Korpraphong, M.D.

Mahidol University

Information Provided By

Mahidol University

Verification Date

January 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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