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

NCT04770714 | Withdrawn FDA Device

• 1 other identifier: 2010134480
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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).

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Global Costs

  The Primary outcome 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.

  Through Study Completion (2 years)

Secondary Outcomes (4)

• Patient Satisfaction using modified Likert scale

  Through Study Completion (2 years)

• Health-Related Quality of Life

  Through Study Completion (2 years)

• Rate of Conversion

  Through Study Completion (2 years)

• Rate of Re-Operation

  Through Study Completion (2 years)

Study Arms (2)

Breast MRI

OTHER

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

Diagnostic Test: Breast MRI

Contrast Enhanced Mammography

OTHER

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

Diagnostic Test: Contrast Enhanced Mammography

Interventions

Breast MRI DIAGNOSTIC_TEST

Standard of Care Breast MRI

Breast MRI

Contrast Enhanced Mammography DIAGNOSTIC_TEST

Standard of Care Contrast Enhanced Mammography

Contrast Enhanced Mammography

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Arizona: lead

Study Sites (1)

Banner University Medical Center Phoenixq

Phoenix, Arizona, 85006, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor, Radiology

Study Record Dates

• First Submitted: January 19, 2021
• First Posted: February 25, 2021
• Study Start: January 19, 2021
• Primary Completion: January 1, 2024
• Study Completion: January 1, 2025
• Last Updated: February 29, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)