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

NCT02587663 | Completed DMC

• 3 other identifiers: 1B-05-5NCI-2011-01365P30CA014089
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Number of patients identified with invasive breast cancer in women who have dense or no dense breasts as determined by the 3 imaging arms

  Up to 4 weeks

Study Arms (3)

Group 1 (standard of care)

ACTIVE COMPARATOR

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

Procedure: Mammography; Procedure: Therapeutic Conventional Surgery; Procedure: Ultrasonography

Group 2 (bilateral whole-breast ultrasound)

EXPERIMENTAL

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

Procedure: Mammography; Procedure: Therapeutic Conventional Surgery; Procedure: Ultrasonography

Group 3 (bilateral breast contrast-enhanced MRI)

EXPERIMENTAL

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

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

Interventions

Contrast-enhanced Magnetic Resonance Imaging PROCEDURE

Undergo bilateral breast contrast enhanced MRI

Also known as: CONTRAST ENHANCED MRI, Contrast-enhanced MRI

Group 3 (bilateral breast contrast-enhanced MRI)

Mammography PROCEDURE

Undergo bilateral mammography

Group 1 (standard of care); Group 2 (bilateral whole-breast ultrasound); Group 3 (bilateral breast contrast-enhanced MRI)

Therapeutic Conventional Surgery PROCEDURE

Undergo breast conserving surgery

Group 1 (standard of care); Group 2 (bilateral whole-breast ultrasound); Group 3 (bilateral breast contrast-enhanced MRI)

Ultrasonography PROCEDURE

Undergo bilateral whole-breast ultrasound

Also known as: ULTRASOUND, Ultrasound Imaging, Ultrasound Test, Ultrasound, Medical, US

Group 2 (bilateral whole-breast ultrasound)

Gadolinium OTHER

Contrast agent used in MRI

Also known as: GBCA

Group 3 (bilateral breast contrast-enhanced MRI)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Southern California: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

USC / Norris Comprehensive Cancer Center

Los Angeles, California, 90033, United States

Location

MeSH Terms

Conditions

Carcinoma, Intraductal, Noninfiltrating; Breast Neoplasms

Interventions

High-Energy Shock Waves; Gadolinium

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Breast Carcinoma In Situ; Carcinoma in Situ; Neoplasms, Ductal, Lobular, and Medullary; Neoplasms by Site; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Ultrasonic Waves; Sound; Radiation, Nonionizing; Radiation; Physical Phenomena; Lanthanoid Series Elements; Metals, Rare Earth; Elements; Inorganic Chemicals; Metals

Study Officials

• Linda Hovanessian-Larsen

  University of Southern California

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2015
• First Posted: October 27, 2015
• Study Start: November 20, 2005
• Primary Completion: November 20, 2011
• Study Completion: November 20, 2012
• Last Updated: May 16, 2019

Record last verified: 2019-05

Locations

US (1)