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

Part of paid clinical trials in Chapel Hill, North Carolina.

Sponsor
UNC Lineberger Comprehensive Cancer Center
Study ID
NCT05754749
Phase
EARLY_PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Iohexol 350 Mg/mL Injectable Solution — 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.

Study Details

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.

Key Dates

Start date
Mar 13, 2023
Status verified
Sep 2025
Primary completion
Aug 22, 2026
Completion
Aug 22, 2026

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • 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.

Primary Outcome Measure

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] ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of North Carolina at Chapel HillChapel HillNorth Carolina27599
Carly Sronce, BSN, RN-BC
[email protected]
919-966-3262
Doreen Steed, R.T. (R)(M)
[email protected]
919-966-0188
Rachel Hitt, MD (PRINCIPAL_INVESTIGATOR)
Yueh Lee, MD, PHD (SUB_INVESTIGATOR)
Cherie Kuzmiak, DO (SUB_INVESTIGATOR)

Find similar trials in Chapel Hill, NC

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
University of North Carolina at Chapel Hill· Chapel Hill, NC

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