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

NCT05754749 · Status: RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2025-09-25

No results posted yet for this study

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.

Conditions

Interventions

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.

Sponsors & Collaborators

  • UNC Lineberger Comprehensive Cancer Center

    lead OTHER

Principal Investigators

  • Rachel Hitt, MD · University of North Carolina, Chapel Hill

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-03-13
Primary Completion
2026-08-22
Completion
2026-08-22
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05754749 on ClinicalTrials.gov