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

July 24, 2026 updated by: UNC Lineberger Comprehensive Cancer Center

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

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
4

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • University of North Carolina at Chapel Hill

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Reader confidence in identifying lesions on CE-DBT compared to contrast enhanced dynamic breast MRI (arbitrary units)
Time Frame: Calculated once all imaging is complete [Anticipated 1.5 years]
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Contrast enhancement curves of CE-DBT compared to conventional MRI (arbitrary units)
Time Frame: Calculated once all imaging is complete [Anticipated 1.5 years]
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)
Time Frame: Calculated once all imaging is complete [Anticipated 1.5 years]
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)
Time Frame: Calculated once all imaging is complete [Anticipated 1.5 years]
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)
Time Frame: Calculated once all imaging is complete [Anticipated 1.5 years]
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)
Time Frame: Calculated once all imaging is complete [Anticipated 1.5 years]
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)
Time Frame: Calculated once all imaging is complete [Anticipated 1.5 years]
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
UNC Lineberger Comprehensive Cancer Center

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Rachel Hitt, MD, University of North Carolina, Chapel Hill

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 13, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 20, 2026

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 20, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 21, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 21, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 6, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 27, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 24, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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