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

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.

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer
• Intervention / Treatment: Drug: Iohexol 350 Mg/mL Injectable Solution

Detailed 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.

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Carly Sronce, BSN, RN-BC; Phone Number: 919-966-3262; Email: carly_sronce@med.unc.edu
• Study Contact Backup: Name: Doreen Steed, R.T.(R)(M); Phone Number: 919-966-0188; Email: doreen_steed@med.unc.edu

Study Locations

• United States
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • Recruiting
      • University of North Carolina at Chapel Hill
      • Contact: Carly Sronce, BSN, RN-BC; Phone Number: 919-966-3262; Email: carly_sronce@med.unc.edu
      • Contact: Doreen Steed, R.T. (R)(M); Phone Number: 919-966-0188; Email: doreen_steed@med.unc.edu
      • Principal Investigator: Rachel Hitt, MD
      • Sub-Investigator: Cherie Kuzmiak, DO
      • Sub-Investigator: Yueh Lee, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Contrast-enhanced digital breast tomosynthesis (CE-DBT); Participants with known breast lesions will be imaged using contrast-enhanced digital breast tomosynthesis (CE-DBT) with Iohexol 350 mg I/mL.

Drug: Iohexol 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.; Other Names: Contrast- enhanced digital breast tomosynthesis (CE-DBT)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Calculated once all imaging is complete [Anticipated 1.5 years]

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	Calculated once all imaging is complete [Anticipated 1.5 years]
Positivity predictive value of CE-DBT compared to contrast enhanced dynamic breast MRI (arbitrary units)	To compare (using a reader study) the positivity predictive value of CE-DBT to the positivity predictive value of contrast enhanced dynamic breast MRI in evaluation of known breast lesions for predicting malignancy.	Calculated once all imaging is complete [Anticipated 1.5 years]
Receiver Operating Characteristic (ROC) curves of CE-DBT compared to contrast enhanced dynamic breast MRI (arbitrary units)	To compare (using a reader study) the ROC curves of CE-DBT to the ROC curves of contrast enhanced dynamic breast MRI in evaluation of known breast lesions for predicting malignancy.	Calculated once all imaging is complete [Anticipated 1.5 years]

Collaborators and Investigators

• Sponsor: UNC Lineberger Comprehensive Cancer Center
• Investigators: Principal Investigator: Rachel Hitt, MD, University of North Carolina, Chapel Hill

Study record dates

Study Major Dates

• Study Start (Actual): March 13, 2023
• Primary Completion (Estimated): August 22, 2026
• Study Completion (Estimated): August 22, 2026

Study Registration Dates

• First Submitted: February 21, 2023
• First Submitted That Met QC Criteria: February 21, 2023
• First Posted (Actual): March 6, 2023

Study Record Updates

• Last Update Posted (Estimated): September 25, 2025
• Last Update Submitted That Met QC Criteria: September 23, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Skin and Connective Tissue Diseases; Breast Neoplasms; Organic Chemicals; Hydrocarbons; Hydrocarbons, Cyclic; Carboxylic Acids; Hydrocarbons, Aromatic; Benzene Derivatives; Acids, Carbocyclic; Benzoates; Triiodobenzoic Acids; Iodobenzoates; Iohexol
• Other Study ID Numbers: LCCC2139

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
• IPD Sharing Time Frame: 9 to 36 months following publication
• IPD Sharing Access Criteria: The investigator who proposes to use the data has approval from an IRB, IEC, or REB, as applicable, and an executed data use/sharing agreement with UNC.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No