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

February 27, 2024 updated by: Michael Morris, University of Arizona

Comparison of Breast MRI Versus Contrast Enhanced Mammography Prior to Surgery in Breast Cancer Patients: a Randomized Controlled Trial

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).

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85006
        • Banner University Medical Center Phoenixq

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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
Diagnostic test: Breast MRI
Standard of Care Breast MRI
Other: 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
Diagnostic test: Contrast Enhanced Mammography
Standard of Care Contrast Enhanced Mammography

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Global Costs
Time Frame: Through Study Completion (2 years)
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient Satisfaction using modified Likert scale
Time Frame: Through Study Completion (2 years)
Patient's reported satisfaction with the initial imaging technique received (CEM versus MRI) will be assessed via Post-Imaging questionnaires designed to gauge patient's opinions about the imaging technique they received.
Through Study Completion (2 years)
Health-Related Quality of Life
Time Frame: Through Study Completion (2 years)
quantifying differences in health-related quality of life (as assessed by the patient reported Euro quality of life 5D questionnaire)
Through Study Completion (2 years)
Rate of Conversion
Time Frame: Through Study Completion (2 years)
Rate of conversion from planned lumpectomy to mastectomy
Through Study Completion (2 years)
Rate of Re-Operation
Time Frame: Through Study Completion (2 years)
rate of re-operation for positive margins
Through Study Completion (2 years)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Arizona

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 19, 2021

Primary Completion (Estimated)

January 1, 2024

Study Completion (Estimated)

January 1, 2025

Study Registration Dates

First Submitted

January 19, 2021

First Submitted That Met QC Criteria

February 24, 2021

First Posted (Actual)

February 25, 2021

Study Record Updates

Last Update Posted (Estimated)

February 29, 2024

Last Update Submitted That Met QC Criteria

February 27, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2010134480

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Study results will be shared on ClinicalTrials.gov in aggregate form.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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