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

NCT ID: NCT05754749

Last Updated: 2025-09-25

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-13
• Study Completion Date: 2026-08-22

Brief 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.

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.

Conditions

Breast Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Iohexol 350 Mg/mL Injectable Solution

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

Contrast- enhanced digital breast tomosynthesis (CE-DBT)

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

UNC Lineberger Comprehensive Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rachel Hitt, MD

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina, Chapel Hill

Locations

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Carly Sronce, BSN, RN-BC

Role: CONTACT

carly_sronce@med.unc.edu

919-966-3262

Doreen Steed, R.T.(R)(M)

Role: CONTACT

doreen_steed@med.unc.edu

919-966-0188

Facility Contacts

Carly Sronce, BSN, RN-BC

Role: primary

carly_sronce@med.unc.edu

919-966-3262

Doreen Steed, R.T. (R)(M)

Role: backup

doreen_steed@med.unc.edu

919-966-0188

Other Identifiers

LCCC2139

Identifier Type: -

Identifier Source: org_study_id