Breast Cancer Clinical Trial

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

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).

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Full 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.

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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)

Study is for people with:

Breast Cancer

Study ID:

NCT04770714

Recruitment Status:

Withdrawn

Sponsor:

University of Arizona

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There is 1 Location for this study

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

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Study is for people with:

Breast Cancer

Study ID:

NCT04770714

Recruitment Status:

Withdrawn

Sponsor:


University of Arizona

How clear is this clinincal trial information?

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