NCT02587663

Extent of Breast Cancer and the Role of Pre-Operative Sonography and MRI

Sonography Compared With MRI in Pre-Operative Evaluation of Patients With Breast Cancer to Determine Extent of Breast Disease

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 300 (actual)
• Sponsor: University of Southern California · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This clinical trial studies mammography and targeted ultrasound with or without whole-breast ultrasound or contrast-enhanced magnetic resonance imaging (MRI) in finding out the extent of disease before surgery in patients with newly diagnosed breast cancer. New diagnostic imaging procedures, such as whole-breast ultrasound or contrast-enhanced MRI, may help find out how far breast cancer has spread. It is not yet known whether mammography and targeted ultrasound are more effective with or without whole-breast ultrasound or contrast-enhanced MRI in finding out how far breast cancer has spread.

Detailed description

PRIMARY OBJECTIVES: I. To determine how surgical treatment is influenced by the three imaging arms. II. To compare three imaging arms in terms of accurately measuring the size of the index lesion and the number and location of tumor foci (using surgical pathology as gold standard). SECONDARY OBJECTIVES: I. In women with dense breasts: To retrospectively compare the accuracy of three imaging arms in measuring the size of the index lesion and the number and location of tumor foci (using surgical pathology as the gold standard). II. To report the incidence of synchronous contralateral breast cancers detected by the three imaging arms. OUTLINE: Patients are assigned to 1 of 3 treatment groups. GROUP 1: Patients undergo standard of care diagnostic imaging comprising bilateral mammography and targeted breast ultrasound. GROUP 2: Patients undergo standard of care diagnostic imaging as in Group 1. Patients also undergo bilateral whole-breast ultrasound. GROUP 3: Patients undergo standard of care diagnostic imaging as in Group 1. Patients also undergo bilateral breast contrast-enhanced MRI. All patients undergo standard of care breast conserving surgery, or mastectomy if the tests indicate a change in the surgical plan.

Conditions

• Ductal Breast Carcinoma In Situ
• Stage IA Breast Cancer
• Stage IB Breast Cancer
• Stage II Breast Cancer

Interventions

Type	Name	Description
PROCEDURE	Contrast-enhanced Magnetic Resonance Imaging	Undergo bilateral breast contrast enhanced MRI
PROCEDURE	Mammography	Undergo bilateral mammography
PROCEDURE	Therapeutic Conventional Surgery	Undergo breast conserving surgery
PROCEDURE	Ultrasonography	Undergo bilateral whole-breast ultrasound
PROCEDURE	Ultrasonography	Undergo targeted breast ultrasound
OTHER	Gadolinium	Contrast agent used in MRI

Timeline

• Start date: 2005-11-20
• Primary completion: 2011-11-20
• Completion: 2012-11-20
• First posted: 2015-10-27
• Last updated: 2019-05-16

Locations

1 site across 1 country: United States