Actively Recruiting

Early Phase 1
Age: 18Years +
FEMALE
NCT05754749

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

Led by UNC Lineberger Comprehensive Cancer Center · Updated on 2025-09-25

20

Participants Needed

1

Research Sites

179 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
Not Eligible

You will not qualify if you...

  • 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 (must be excluded by negative urine beta-HCG results within 24 hours prior to the scan or patient history)

AI-Screening

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Trial Site Locations

Total: 1 location

1

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States, 27599

Actively Recruiting

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Research Team

C

Carly Sronce, BSN, RN-BC

CONTACT

D

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

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

DIAGNOSTIC

Number of Arms

1

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