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

Breast Cancer Clinical Trial

Official title:

Comparison of Breast MRI Versus Contrast Enhanced Mammography Prior to Surgery in Breast Cancer Patients: a Randomized Controlled Trial

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04770714
• Other study ID #: 2010134480
• Status: Withdrawn
• Phase: N/A
• Start date: January 19, 2021
• Est. completion date: January 2025

Study information

• Verified date: February 2024
• Source: University of Arizona
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 2025
• Est. primary completion date: January 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Diagnostic Test:
• Breast MRI
Standard of Care Breast MRI
• Contrast Enhanced Mammography
Standard of Care Contrast Enhanced Mammography

Locations

Country	Name	City	State
United States	Banner University Medical Center Phoenixq	Phoenix	Arizona

Sponsors (1)

Lead Sponsor	Collaborator
University of Arizona

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Through Study Completion (2 years)
Secondary	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.	Through Study Completion (2 years)
Secondary	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)	Through Study Completion (2 years)
Secondary	Rate of Conversion	Rate of conversion from planned lumpectomy to mastectomy	Through Study Completion (2 years)
Secondary	Rate of Re-Operation	rate of re-operation for positive margins	Through Study Completion (2 years)