Overview

This trial is active, not recruiting.

Conditions ductal breast carcinoma in situ, stage ia breast cancer, stage ib breast cancer, stage ii breast cancer
Treatments contrast-enhanced magnetic resonance imaging, mammography, therapeutic conventional surgery, ultrasonography, gadolinium
Sponsor University of Southern California
Collaborator National Cancer Institute (NCI)
Start date November 2005
End date November 2011
Trial size 300 participants
Trial identifier NCT02587663, 1B-05-5, NCI-2011-01365, P30CA014089

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose diagnostic
Arm
(Active Comparator)
Patients undergo standard of care diagnostic imaging comprising bilateral mammography and targeted breast ultrasound.
mammography
Undergo bilateral mammography
therapeutic conventional surgery
Undergo breast conserving surgery
ultrasonography ULTRASOUND
Undergo targeted breast ultrasound
(Experimental)
Patients undergo standard of care diagnostic imaging as in Group 1. Patients also undergo bilateral whole-breast ultrasound.
mammography
Undergo bilateral mammography
therapeutic conventional surgery
Undergo breast conserving surgery
ultrasonography ULTRASOUND
Undergo bilateral whole-breast ultrasound
ultrasonography ULTRASOUND
Undergo targeted breast ultrasound
(Experimental)
Patients undergo standard of care diagnostic imaging as in Group 1. Patients also undergo bilateral breast contrast-enhanced MRI.
contrast-enhanced magnetic resonance imaging CONTRAST ENHANCED MRI
Undergo bilateral breast contrast enhanced MRI
mammography
Undergo bilateral mammography
therapeutic conventional surgery
Undergo breast conserving surgery
ultrasonography ULTRASOUND
Undergo targeted breast ultrasound
gadolinium GBCA
Contrast agent used in MRI

Primary Outcomes

Measure
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

Secondary Outcomes

Measure
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

Eligibility Criteria

Female participants at least 18 years old.

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)

Additional Information

Official title Sonography Compared With MRI in Pre-Operative Evaluation of Patients With Breast Cancer to Determine Extent of Breast Disease
Principal investigator Linda Hovanessian-Larsen
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.
Trial information was received from ClinicalTrials.gov and was last updated in October 2015.
Information provided to ClinicalTrials.gov by University of Southern California.