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

Early Phase 1TerminatedNCT05754749

UNC Lineberger Comprehensive Cancer Center4 enrolled

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Breast Cancer

Interventions

Iohexol 350 Mg/mL Injectable SolutionDRUG

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.

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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)

Locations (1)

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States

Outcomes

Primary Outcomes

Reader confidence in identifying lesions on CE-DBT compared to contrast enhanced dynamic breast MRI (arbitrary units)

To compare (using a reader study) the reader confidence in identifying lesions on CE-DBT to the reader confidence in identifying lesions on contrast enhanced dynamic breast MRI.

Time frame: Calculated once all imaging is complete [Anticipated 1.5 years]

Secondary Outcomes

Contrast enhancement curves of CE-DBT compared to conventional MRI (arbitrary units)

To compare (using a reader study) the contrast enhancement curves of CE-DBT to the contrast enhancement curves of contrast enhanced dynamic breast MRI in evaluation of known breast lesions for predicting malignancy.

Time frame: Calculated once all imaging is complete [Anticipated 1.5 years]

Diagnostic accuracy of CE-DBT compared to contrast enhanced dynamic breast MRI (arbitrary units)

To compare (using a reader study) the diagnostic accuracy of CE-DBT to the diagnostic accuracy of contrast enhanced dynamic breast MRI in evaluation of known breast lesions for predicting malignancy.

Time frame: Calculated once all imaging is complete [Anticipated 1.5 years]

Sensitivity of CE-DBT compared to contrast enhanced dynamic breast MRI (arbitrary units)

To compare (using a reader study) the sensitivity of CE-DBT to the sensitivity of contrast enhanced dynamic breast MRI in evaluation of known breast lesions for predicting malignancy.

Time frame: Calculated once all imaging is complete [Anticipated 1.5 years]

Specificity of CE-DBT compared to contrast enhanced dynamic breast MRI (arbitrary units)

To compare (using a reader study) the specificity of CE-DBT to the specificity of contrast enhanced dynamic breast MRI in evaluation of known breast lesions for predicting malignancy.

Data from ClinicalTrials.gov

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