Prospective Comparison of Breast MRI vs Contrast Mammography Prior to Surgery in Breast Cancer Patients

NCT ID: NCT04770714

Last Updated: 2024-02-29

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-19
• Study Completion Date: 2025-01-31

Brief Summary

In current clinical practice, women with biopsy proven breast cancer can be sent for breast magnetic resonance imaging (MRI) or contrast enhanced mammography (CEM) prior to surgery in order to delineate the extent of a known cancer and / or assess for the presence of occult secondary cancers. This study seeks to compare the global costs (based on actual reimbursement rates) of CEM/breast MRI, downstream imaging testing, and diagnostic procedures in women randomized to breast MRI versus CEM. Secondary goals are to compare patient preferences for CEM vs MRI and clinically relevant outcomes (e.g. conversion from lumpectormy to mastecomy).

Detailed Description

This is a pilot randomized controlled trial comparing the global costs of two standard of care imaging techniques in patients with a new breast cancer diagnosis and planned breast conservation surgery. Patients enrolled in this study will be randomized to either CEM or breast MRI. The purpose of this study is to compare the global costs (based on actual reimbursement rates) of initial imaging modality (CEM or breast MRI), downstream imaging related to breast cancer evaluation, and diagnostic breast procedures in women randomized to breast MRI versus CEM.

Secondary endpoints include assessment of patient's reported satisfaction with the initial imaging technique received (CEM versus MRI), quantifying differences in health-related quality of life (as assessed by the patient reported Euro quality of life 5D questionnaire), rate of conversion from planned lumpectomy to mastectomy, and rate of re-operation for positive margins.

Conditions

Breast Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Breast MRI

Patients in this arm will be randomized to receive a Breast MRI in order to delineate the extent of a known cancer and / or assess for the presence of occult secondary cancers

Group Type: OTHER

Breast MRI

Intervention Type: DIAGNOSTIC_TEST

Standard of Care Breast MRI

Contrast Enhanced Mammography

Patients in this arm will be randomized to receive a Contrast Enhanced Mammograph in order to delineate the extent of a known cancer and / or assess for the presence of occult secondary cancers

Group Type: OTHER

Contrast Enhanced Mammography

Intervention Type: DIAGNOSTIC_TEST

Standard of Care Contrast Enhanced Mammography

Interventions

Breast MRI

Standard of Care Breast MRI

Intervention Type: DIAGNOSTIC_TEST

Contrast Enhanced Mammography

Standard of Care Contrast Enhanced Mammography

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• Women aged 18 years or older with newly diagnosed breast cancer and planned breast conservation surgery
• Clinically indicated referral for breast MRI or contrast mammogram prior to surgery
• Provision of informed consent

Exclusion Criteria

• Planned neoadjuvant chemotherapy
• Patients that are medically unstable
• Pregnancy
• Patients with known contraindication to contrast mammography, including:

• Glomerular filtration rate <30
• Known adverse reaction to iodinated contrast material
• Patients with known contraindication to Breast MRI including:

• Glomerular filtration rate <30
• Known adverse reaction to gadolinium contrast material
• Non-MRI conditional device or catheter
• Brain aneurysm clip implanted before 1995
• Cochlear implant
• Ocular foreign body (e.g. metal shavings)
• Insulin pump
• Patients unable to read and understand English or Spanish (i.e. an inability to complete study questionnaires)

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of Arizona

OTHER

Sponsor Role: lead

Responsible Party

Michael Morris

Clinical Assistant Professor, Radiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Banner University Medical Center Phoenixq

Phoenix, Arizona, United States

Countries

United States

Other Identifiers

2010134480

Identifier Type: -

Identifier Source: org_study_id