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

RECRUITINGEarly 1Sponsored by UNC Lineberger Comprehensive Cancer Center
Actively Recruiting
PhaseEarly 1
SponsorUNC Lineberger Comprehensive Cancer Center
Started2023-03-13
Est. completion2026-08-22
Eligibility
Age18 Years+
SexFEMALE
Healthy vol.Accepted
Locations1 site

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.

Eligibility

Age: 18 Years+Sex: FEMALEHealthy volunteers accepted
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)

Conditions2

Breast CancerCancer

Locations1 site

University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
Carly Sronce, BSN, RN-BC919-966-3262carly_sronce@med.unc.edu

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