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

University of Southern California

Status: Completed

Conditions: Stage IB Breast Cancer; Stage II Breast Cancer; Stage IA Breast Cancer; Ductal Breast Carcinoma In Situ

Treatments: Procedure: Therapeutic Conventional Surgery; Other: Gadolinium; Procedure: Ultrasonography; Procedure: Mammography; Procedure: Contrast-enhanced Magnetic Resonance Imaging

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02587663

1B-05-5 (Other Identifier)

NCI-2011-01365 (Registry Identifier)

P30CA014089 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 300 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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300 participants in 3 patient groups

Group 1 (standard of care)

Active Comparator group

Description:

Patients undergo standard of care diagnostic imaging comprising bilateral mammography and targeted breast ultrasound.

Treatment:

Procedure: Ultrasonography

Procedure: Mammography

Procedure: Therapeutic Conventional Surgery

Procedure: Ultrasonography

Group 2 (bilateral whole-breast ultrasound)

Experimental group

Description:

Patients undergo standard of care diagnostic imaging as in Group 1. Patients also undergo bilateral whole-breast ultrasound.

Treatment:

Procedure: Ultrasonography

Procedure: Mammography

Procedure: Therapeutic Conventional Surgery

Procedure: Ultrasonography

Group 3 (bilateral breast contrast-enhanced MRI)

Experimental group

Description:

Patients undergo standard of care diagnostic imaging as in Group 1. Patients also undergo bilateral breast contrast-enhanced MRI.

Treatment:

Procedure: Contrast-enhanced Magnetic Resonance Imaging

Procedure: Ultrasonography

Procedure: Mammography

Procedure: Therapeutic Conventional Surgery

Other: Gadolinium

Procedure: Ultrasonography