Status:

WITHDRAWN

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

Lead Sponsor:

University of Arizona

Conditions:

Breast Cancer

Eligibility:

FEMALE

18+ years

Phase:

NA

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 delinea...

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...

Eligibility Criteria

Inclusion

  • 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

  • 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)

Key Trial Info

Start Date :

January 19 2021

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

January 1 2025

Estimated Enrollment :

Patients enrolled

Trial Details

Trial ID

NCT04770714

Start Date

January 19 2021

End Date

January 1 2025

Last Update

February 29 2024

Active Locations (1)

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1

Banner University Medical Center Phoenixq

Phoenix, Arizona, United States, 85006