Stage II Breast Cancer Clinical Trial
Official title:
Sonography Compared With MRI in Pre-Operative Evaluation of Patients With Breast Cancer to Determine Extent of Breast Disease
Verified date | May 2019 |
Source | University of Southern California |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 300 |
Est. completion date | November 20, 2012 |
Est. primary completion date | November 20, 2011 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
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) |
Country | Name | City | State |
---|---|---|---|
United States | USC / Norris Comprehensive Cancer Center | Los Angeles | California |
Lead Sponsor | Collaborator |
---|---|
University of Southern California | National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 |
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