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

Primary Purpose

Breast Cancer

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Breast MRI
Contrast Enhanced Mammography
Sponsored by
University of Arizona
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Breast Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept 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)

Sites / Locations

  • Banner University Medical Center PhoenixqRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Breast MRI

Contrast Enhanced Mammography

Arm 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

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

Outcomes

Primary Outcome Measures

Global Costs
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.

Secondary Outcome Measures

Patient Satisfaction using modified Likert scale
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.
Health-Related Quality of Life
quantifying differences in health-related quality of life (as assessed by the patient reported Euro quality of life 5D questionnaire)
Rate of Conversion
Rate of conversion from planned lumpectomy to mastectomy
Rate of Re-Operation
rate of re-operation for positive margins

Full Information

First Posted
January 19, 2021
Last Updated
February 24, 2021
Sponsor
University of Arizona
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1. Study Identification

Unique Protocol Identification Number
NCT04770714
Brief Title
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

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Unknown status
Study Start Date
January 19, 2021 (Actual)
Primary Completion Date
January 2022 (Anticipated)
Study Completion Date
January 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Arizona

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Breast MRI
Arm Type
Other
Arm 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
Arm Title
Contrast Enhanced Mammography
Arm Type
Other
Arm 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
Intervention Type
Diagnostic Test
Intervention Name(s)
Breast MRI
Intervention Description
Standard of Care Breast MRI
Intervention Type
Diagnostic Test
Intervention Name(s)
Contrast Enhanced Mammography
Intervention Description
Standard of Care Contrast Enhanced Mammography
Primary Outcome Measure Information:
Title
Global Costs
Description
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.
Time Frame
Through Study Completion (2 years)
Secondary Outcome Measure Information:
Title
Patient Satisfaction using modified Likert scale
Description
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.
Time Frame
Through Study Completion (2 years)
Title
Health-Related Quality of Life
Description
quantifying differences in health-related quality of life (as assessed by the patient reported Euro quality of life 5D questionnaire)
Time Frame
Through Study Completion (2 years)
Title
Rate of Conversion
Description
Rate of conversion from planned lumpectomy to mastectomy
Time Frame
Through Study Completion (2 years)
Title
Rate of Re-Operation
Description
rate of re-operation for positive margins
Time Frame
Through Study Completion (2 years)

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Michael Morris, MD
Phone
(602)839-4850
Email
COMPHX-cress-compliance@email.arizona.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Andrea Arellano, BS, CCRP
Phone
602-255-7557
Email
andrea24@email.arizona.edu
Facility Information:
Facility Name
Banner University Medical Center Phoenixq
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85006
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mason Burchfield
Phone
602-255-7551
Email
mlburchfi@arizona.edu
First Name & Middle Initial & Last Name & Degree
Elena Young
Phone
6022557553
Email
elenay@arizona.edu
First Name & Middle Initial & Last Name & Degree
Michael Morris, MD

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Study results will be shared on ClinicalTrials.gov in aggregate form.

Learn more about this trial

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

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