Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04770714
Recruitment Status : Recruiting
First Posted : February 25, 2021
Last Update Posted : February 25, 2021
Sponsor:
Information provided by (Responsible Party):
Michael Morris, University of Arizona

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).

Condition or disease Intervention/treatment Phase
Breast Cancer Diagnostic Test: Breast MRI Diagnostic Test: Contrast Enhanced Mammography Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Comparison of Breast MRI Versus Contrast Enhanced Mammography Prior to Surgery in Breast Cancer Patients: a Randomized Controlled Trial
Actual Study Start Date : January 19, 2021
Estimated Primary Completion Date : January 2022
Estimated Study Completion Date : January 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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

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




Primary Outcome Measures :
  1. Global Costs [ Time Frame: Through Study Completion (2 years) ]
    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 :
  1. Patient Satisfaction using modified Likert scale [ Time Frame: Through Study Completion (2 years) ]
    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.

  2. Health-Related Quality of Life [ Time Frame: Through Study Completion (2 years) ]
    quantifying differences in health-related quality of life (as assessed by the patient reported Euro quality of life 5D questionnaire)

  3. Rate of Conversion [ Time Frame: Through Study Completion (2 years) ]
    Rate of conversion from planned lumpectomy to mastectomy

  4. Rate of Re-Operation [ Time Frame: Through Study Completion (2 years) ]
    rate of re-operation for positive margins



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04770714


Contacts
Layout table for location contacts
Contact: Michael Morris, MD (602)839-4850 COMPHX-cress-compliance@email.arizona.edu
Contact: Andrea Arellano, BS, CCRP 602-255-7557 andrea24@email.arizona.edu

Locations
Layout table for location information
United States, Arizona
Banner University Medical Center Phoenixq Recruiting
Phoenix, Arizona, United States, 85006
Contact: Mason Burchfield    602-255-7551    mlburchfi@arizona.edu   
Contact: Elena Young    6022557553    elenay@arizona.edu   
Principal Investigator: Michael Morris, MD         
Sponsors and Collaborators
University of Arizona
Layout table for additonal information
Responsible Party: Michael Morris, Clinical Assistant Professor, Radiology, University of Arizona
ClinicalTrials.gov Identifier: NCT04770714    
Other Study ID Numbers: 2010134480
First Posted: February 25, 2021    Key Record Dates
Last Update Posted: February 25, 2021
Last Verified: February 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Study results will be shared on ClinicalTrials.gov in aggregate form.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Additional relevant MeSH terms:
Layout table for MeSH terms
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases