Purpose

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).

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
Female
Accepts Healthy Volunteers
No

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 Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Diagnostic
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
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

Recruiting Locations

Banner University Medical Center Phoenixq
Phoenix, Arizona 85006
Contact:
Mason Burchfield
602-255-7551
mlburchfi@arizona.edu

More Details

Status
Recruiting
Sponsor
University of Arizona

Study Contact

Michael Morris, MD
(602)839-4850
COMPHX-cress-compliance@email.arizona.edu

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.