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

UNC Lineberger Comprehensive Cancer Center

Status and phase

Enrolling

Early Phase 1

Conditions

Breast Cancer

Treatments

Drug: Iohexol 350 Mg/mL Injectable Solution

Study type

Interventional

Funder types

Other

Identifiers

NCT05754749

LCCC2139

Details and patient eligibility

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.

Full 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.

Enrollment

20 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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)