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Comparison of CE-DBT and MRI in Patients With Known Breast Lesions

Comparison of CE-DBT and MRI in Patients With Known Breast Lesions

Recruiting
18 years and older
Female
Phase N/A

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Overview

The purpose of this pilot study is to compare radiologist confidence level in evaluating patients with known breast lesions between contrast enhanced digital breast tomosynthesis (CE- DBT) and contrast enhanced dynamic magnetic resonance imaging (CE-MRI) acquired as a part of a standard clinical workup.

Description

This is a pilot study of CE-DBT scans to evaluate its utility relative to breast CE-MRI. Twenty women who have planned or received conventional breast MRI imaging at UNC Hospitals will be recruited for the study. Participants will be scanned with the DBT system after the administration of iodinated contrast agent. Images will be acquired prior to the administration of contrast, followed by at approximately 2 minutes and 5 minutes. For the purposes of this study, imaging will focus on a single breast to simplify data acquisition.

Eligibility

Inclusion Criteria:

  • Women at least 18 years old
  • Planned or received conventional breast MRI at UNC Hospitals within 3 months prior to or after the research scan
  • Suspected breast lesion based on prior imaging (BIRADS 4 or greater)
  • Able to provide written informed consent

Exclusion Criteria:

  • Severe untreatable claustrophobia
  • Implanted metallic devices, parts, vascular clips, or other foreign bodies (including breast implants)
  • Known hypersensitivity to iodinated contrast agent or to any component of iodinated contrast refractory to standard medications (antihistamines, steroids)
  • Impaired kidney function (serum creatinine level > 1.8 mg/dl or a glomerular filtration rate < 60 as approximated using serum creatinine levels within the last 30 days prior to the research scan) unless anuric and on dialysis
  • Any woman who is pregnant or has reason to believe she is pregnant (the possibility of pregnancy has to be excluded by negative urine β-HCG results, obtained within 24 hours prior to the research scan, or on the basis of patient history, as defined by the UNC IRB SOP 4801)

Study details
    Breast Cancer

NCT05754749

UNC Lineberger Comprehensive Cancer Center

30 April 2024

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