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

Invasive Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01597999
• Other study ID #: 15262
• Secondary ID: 578/2533(EC4)
• Status: Recruiting
• Phase: Phase 4
• First received: May 13, 2011
• Last updated: January 21, 2013
• Start date: February 2011
• Est. completion date: December 2013

Study information

• Verified date: January 2013
• Source: Mahidol University
• Contact: Dr.Pornpim Korpraphong, Assist.Prof.
• Phone: 6624197000
• Email: pfuang[@]yahoo.com
• Is FDA regulated: No
• Health authority: Thailand: Ethical Committee
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 2013
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

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

Related Conditions & MeSH terms

• Breast Neoplasms
• Invasive Breast Cancer

Intervention

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

Locations

Country	Name	City	State
Thailand	Faculty of Medicine Siriraj Hospital	Bangkoknoi	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	ascertain the accuracy of pre-operative DCE-MRI in terms of detection and characterization of breast cancer, as compared to tissue biopsy.	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	1 year	No