Clinical trial NCT04770714: Prospective Comparison of Breast MRI vs Contrast Mammography Prior to Surgery in Breast Cancer Patients
Official title: Comparison of Breast MRI Versus Contrast Enhanced Mammography Prior to Surgery in Breast Cancer Patients: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Breast Cancer
Lead sponsor: University of Arizona
Sponsor class: OTHER
First posted: 2021-02-25
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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).

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.

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)

Primary outcomes:
measure: Global Costs
timeFrame: Through Study Completion (2 years)
Secondary outcomes:
measure: Patient Satisfaction using modified Likert scale
timeFrame: Through Study Completion (2 years)
measure: Health-Related Quality of Life
timeFrame: Through Study Completion (2 years)
measure: Rate of Conversion
timeFrame: Through Study Completion (2 years)
measure: Rate of Re-Operation
timeFrame: Through Study Completion (2 years)
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Banner University Medical Center Phoenixq
state: Arizona
Study officials:
References: