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

Study Overview
=================
Brief 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.

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

Conditions
-----------------
Ductal Breast Carcinoma In Situ, Stage IA Breast Cancer, Stage IB Breast Cancer, Stage II Breast Cancer

Intervention / Treatment
-----------------
* Procedure: Contrast-enhanced Magnetic Resonance Imaging
* Procedure: Mammography
* Procedure: Therapeutic Conventional Surgery
* Procedure: Ultrasonography
* Procedure: Ultrasonography
* Other: Gadolinium


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Competent to provide informed consent Pathologically proven invasive breast cancer or ductal carcinoma in situ (DCIS) originally identified clinically or mammographically and diagnosed by percutaneous core biopsy Eligible for breast conserving surgery followed by radiation therapy Exclusion Criteria: Women with surgical excisional biopsy that diagnosed the breast cancer Women with clinical or mammographic findings where breast conserving surgery is not an option Women that clinically or mammographically have breast cancers that are fixed to skin Women receiving neoadjuvant chemotherapy prior to surgery Women having contraindications to contrast-enhanced (CE)-MRI examination (e.g., claustrophobia and allergy to gadolinium)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group 1 (standard of care)<br>Patients undergo standard of care diagnostic imaging comprising bilateral mammography and targeted breast ultrasound. | Procedure: Mammography<br>* Undergo bilateral mammography<br>Procedure: Therapeutic Conventional Surgery<br>* Undergo breast conserving surgery<br>Procedure: Ultrasonography<br>* Undergo targeted breast ultrasound<br>* Other names: US;|
| Experimental: Group 2 (bilateral whole-breast ultrasound)<br>Patients undergo standard of care diagnostic imaging as in Group 1. Patients also undergo bilateral whole-breast ultrasound. | Procedure: Mammography<br>* Undergo bilateral mammography<br>Procedure: Therapeutic Conventional Surgery<br>* Undergo breast conserving surgery<br>Procedure: Ultrasonography<br>* Undergo bilateral whole-breast ultrasound<br>* Other names: US;Procedure: Ultrasonography<br>* Undergo targeted breast ultrasound<br>* Other names: US;|
| Experimental: Group 3 (bilateral breast contrast-enhanced MRI)<br>Patients undergo standard of care diagnostic imaging as in Group 1. Patients also undergo bilateral breast contrast-enhanced MRI. | Procedure: Contrast-enhanced Magnetic Resonance Imaging<br>* Undergo bilateral breast contrast enhanced MRI<br>* Other names: Contrast-enhanced MRI;Procedure: Mammography<br>* Undergo bilateral mammography<br>Procedure: Therapeutic Conventional Surgery<br>* Undergo breast conserving surgery<br>Procedure: Ultrasonography<br>* Undergo targeted breast ultrasound<br>* Other names: US;Other: Gadolinium<br>* Contrast agent used in MRI<br>* Other names: GBCA;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference between the longest diameter of the index lesion as determined by imaging versus as determined by the pathologist | Every attempt will be made to identify a transformation for the difference in the lengths of the largest diameters. If none are found, then the data will be summarized with histograms, medians, quartiles, and ranges. If a transformation is found, means, standard deviations, and 95% confidence intervals will be reported instead of the median and quartiles. Differences between three imaging methods will be compared using a paired t-test (or paired rank sum test). | Up to 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients identified with invasive breast cancer in women who have dense or no dense breasts as determined by the 3 imaging arms | The analyses above will be rerun, stratifying by breast density: the differences in the modalities will be estimated for women with dense breasts and without, and the differences between the two groups of women will also be estimated. Dense will be defined as dense parenchyma involving more than 50% of breast volume. | Up to 4 weeks |