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

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

Plain Language Summary

Simplified for easier understanding

This study is comparing two breast imaging techniques — contrast-enhanced digital breast tomosynthesis (CE-DBT, a specialized 3D mammogram with contrast dye) and MRI — in women with suspicious breast lesions, to see if CE-DBT can offer similar diagnostic accuracy with greater convenience. **You may be eligible if...** - You are a woman, 18 or older - You have a suspected breast lesion rated BIRADS 4 or higher on prior imaging (meaning it needs further evaluation) - You have had or are scheduled to have a breast MRI at UNC Hospitals within 3 months of the research scan - You can provide written informed consent **You may NOT be eligible if...** - You have severe claustrophobia that cannot be treated - You have metallic implants (including breast implants) that are incompatible with MRI - You have a known allergy to iodine-based contrast dye Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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.


Locations(1)

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States

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NCT05754749


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