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

May 14, 2019 updated by: University of Southern California

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90033
        • USC / Norris Comprehensive Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group 1 (standard of care)
Patients undergo standard of care diagnostic imaging comprising bilateral mammography and targeted breast ultrasound.
Procedure: Mammography
Undergo bilateral mammography
Procedure: Therapeutic Conventional Surgery
Undergo breast conserving surgery
Procedure: Ultrasonography
Undergo bilateral whole-breast ultrasound
Other Names:
  • Ultrasound Imaging
  • Ultrasound Test
  • Ultrasound, Medical
  • US
  • ULTRASOUND
Procedure: Ultrasonography
Undergo targeted breast ultrasound
Other Names:
  • Ultrasound Imaging
  • Ultrasound Test
  • Ultrasound, Medical
  • US
  • ULTRASOUND
Experimental: Group 2 (bilateral whole-breast ultrasound)
Patients undergo standard of care diagnostic imaging as in Group 1. Patients also undergo bilateral whole-breast ultrasound.
Procedure: Mammography
Undergo bilateral mammography
Procedure: Therapeutic Conventional Surgery
Undergo breast conserving surgery
Procedure: Ultrasonography
Undergo bilateral whole-breast ultrasound
Other Names:
  • Ultrasound Imaging
  • Ultrasound Test
  • Ultrasound, Medical
  • US
  • ULTRASOUND
Procedure: Ultrasonography
Undergo targeted breast ultrasound
Other Names:
  • Ultrasound Imaging
  • Ultrasound Test
  • Ultrasound, Medical
  • US
  • ULTRASOUND
Experimental: Group 3 (bilateral breast contrast-enhanced MRI)
Patients undergo standard of care diagnostic imaging as in Group 1. Patients also 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
Other Names:
  • Ultrasound Imaging
  • Ultrasound Test
  • Ultrasound, Medical
  • US
  • ULTRASOUND
Procedure: Ultrasonography
Undergo targeted breast ultrasound
Other Names:
  • Ultrasound Imaging
  • Ultrasound Test
  • Ultrasound, Medical
  • US
  • ULTRASOUND
Procedure: Contrast-enhanced Magnetic Resonance Imaging
Undergo bilateral breast contrast enhanced MRI
Other Names:
  • CONTRAST ENHANCED MRI
  • Contrast-enhanced MRI
Other: Gadolinium
Contrast agent used in MRI
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
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).
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
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.
Up to 4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Southern California

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Linda Hovanessian-Larsen, University of Southern California

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 20, 2005

Primary Completion (Actual)

November 20, 2011

Study Completion (Actual)

November 20, 2012

Study Registration Dates

First Submitted

September 13, 2015

First Submitted That Met QC Criteria

October 26, 2015

First Posted (Estimate)

October 27, 2015

Study Record Updates

Last Update Posted (Actual)

May 16, 2019

Last Update Submitted That Met QC Criteria

May 14, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1B-05-5 (Other Identifier: USC / Norris Comprehensive Cancer Center)
  • P30CA014089 (U.S. NIH Grant/Contract)
  • NCI-2011-01365 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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