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

University of Arizona

Status: Withdrawn

Conditions: Breast Cancer

Treatments: Diagnostic Test: Breast MRI; Diagnostic Test: Contrast Enhanced Mammography

Study type: Interventional

Funder types: Other

Identifiers

NCT04770714

2010134480

Details and patient eligibility

About

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).

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.

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Breast MRI

Other group

Description:

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

Treatment:

Diagnostic Test: Breast MRI

Contrast Enhanced Mammography

Other group

Description:

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

Treatment:

Diagnostic Test: Contrast Enhanced Mammography