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

Phase 4

• Conditions: Invasive Breast Cancer
• Interventions: Radiation: MRI

• Registration Number: NCT01597999
• Lead Sponsor: Mahidol University

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 Timeline

• Study Start: 2011-02
• Study First Submitted: 2011-05-13
• Study First Submitted QC: 2012-05-14
• Study First Posted: 2012-05-15
• Primary Completion: 2012-07
• Status Verified: 2013-01
• Last Update Submitted: 2013-01-21
• Last Update Posted: 2013-01-23
• Study Completion: 2013-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
No treatment	MRI	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 )

Primary Outcome Measures

Name	Time	Method
study the benefits of DCE-MRI using Gadovist in prognostic determination of early invasive breast cancer	1 year	The benefits of breast tumor diagnosis from DCE-MRI in early invasive breast cancer with poor prognostic features

Secondary Outcome Measures

Name	Time	Method
ascertain the accuracy of pre-operative DCE-MRI in terms of detection and characterization of breast cancer, as compared to tissue biopsy.	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

Trial Locations

Locations (1)

Faculty of Medicine Siriraj Hospital; 🇹🇭 Bangkoknoi, Bangkok, Thailand