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NCT Number: NCT02587663

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

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.

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Key information

Conditions

Ductal Breast Carcinoma In Situ Adenocarcinoma Breast Carcinoma In Situ Breast Diseases Breast Neoplasms Carcinoma Carcinoma in Situ Carcinoma, Intraductal, Noninfiltrating Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Ductal, Lobular, and Medullary Neoplasms, Glandular and Epithelial Skin Diseases Skin and Connective Tissue Diseases Stage IA Breast Cancer Stage IB Breast Cancer Stage II Breast Cancer

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

USC / Norris Comprehensive Cancer Center

Los Angeles, California, 90033, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Contrast-enhanced Magnetic Resonance Imaging

Procedure

Undergo bilateral breast contrast enhanced MRI

Other names: CONTRAST ENHANCED MRI, Contrast-enhanced MRI

Mammography

Procedure

Undergo bilateral mammography

therapeutic conventional surgery

Procedure

Undergo breast conserving surgery

Ultrasonography

Procedure

Undergo bilateral whole-breast ultrasound

Other names: ULTRASOUND, Ultrasound Imaging, Ultrasound Test, Ultrasound, Medical, US

Gadolinium

Other

Contrast agent used in MRI

Other names: GBCA

Primary outcomes

  1. Difference between the longest diameter of the index lesion as determined by imaging versus as determined by the pathologist

    Time frame: Up to 4 weeks

    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).

Secondary outcomes

  1. Number of patients identified with invasive breast cancer in women who have dense or no dense breasts as determined by the 3 imaging arms

    Time frame: Up to 4 weeks

    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.

Sponsors and collaborators

Lead sponsor

University of Southern California

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2011
Study completion
2012
First posted
Oct 27, 2015
Registry last updated
May 16, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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