RecruitingEarly Phase 1NCT05754749

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

Comparison of Contrast Enhanced Digital Breast Tomosynthesis and Magnetic Resonance Imaging in Patients With Known Breast Lesions

Sponsor

UNC Lineberger Comprehensive Cancer Center

Enrollment

20 participants

Start Date

Mar 13, 2023

Study Type

INTERVENTIONAL

Conditions

Breast Cancer

Summary

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.

Eligibility

Sex: FEMALEMin Age: 18 Years

Inclusion Criteria4

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 Criteria5

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)

Interventions

DRUGIohexol 350 Mg/mL Injectable Solution

Participants will be scanned with the digital breast tomosynthesis (DBT) system before and after the intravenous administration of iodinated contrast agent, iohexol 350mg I/mL at a dose of 1.5 mL/kg body weight. Images will be acquired of the breast of interest prior to the administration of contrast, followed by at approximately 2 minutes and 5 minutes after administration. For the purposes of this study, imaging will focus on a single breast to simplify data acquisition.