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

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02587663
• Other study ID #: 1B-05-5
• Secondary ID: NCI-2011-013651B
• Status: Completed
• Phase: N/A
• Start date: November 20, 2005
• Est. completion date: November 20, 2012

Study information

• Verified date: May 2019
• Source: University of Southern California
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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)

Related Conditions & MeSH terms

• Breast Carcinoma In Situ
• Breast Neoplasms
• Carcinoma in Situ
• Carcinoma, Ductal, Breast
• Carcinoma, Intraductal, Noninfiltrating
• Ductal Breast Carcinoma In Situ
• Stage IA Breast Cancer
• Stage IB Breast Cancer
• Stage II Breast Cancer

Intervention

Procedure:
• Contrast-enhanced Magnetic Resonance Imaging
Undergo bilateral breast contrast enhanced MRI
• Mammography
Undergo bilateral mammography
• Therapeutic Conventional Surgery
Undergo breast conserving surgery
• Ultrasonography
Undergo bilateral whole-breast ultrasound
• Ultrasonography
Undergo targeted breast ultrasound

Other:
• Gadolinium
Contrast agent used in MRI

Locations

Country	Name	City	State
United States	USC / Norris Comprehensive Cancer Center	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
University of Southern California	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

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