Comparison of CE-DBT and MRI in Patients With Known Breast Lesions
- Conditions
- Breast Cancer
- Interventions
- Registration Number
- NCT05754749
- Lead Sponsor
- UNC Lineberger Comprehensive Cancer Center
- Brief 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.
- Detailed 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 20
- 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
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Contrast-enhanced digital breast tomosynthesis (CE-DBT) Iohexol 350 Mg/mL Injectable Solution Participants with known breast lesions will be imaged using contrast-enhanced digital breast tomosynthesis (CE-DBT) with Iohexol 350 mg I/mL.
- Primary Outcome Measures
Name Time Method Reader confidence in identifying lesions on CE-DBT compared to contrast enhanced dynamic breast MRI (arbitrary units) Calculated once all imaging is complete [Anticipated 1.5 years] To compare (using a reader study) the reader confidence in identifying lesions on CE-DBT to the reader confidence in identifying lesions on contrast enhanced dynamic breast MRI.
- Secondary Outcome Measures
Name Time Method Sensitivity of CE-DBT compared to contrast enhanced dynamic breast MRI (arbitrary units) Calculated once all imaging is complete [Anticipated 1.5 years] To compare (using a reader study) the sensitivity of CE-DBT to the sensitivity of contrast enhanced dynamic breast MRI in evaluation of known breast lesions for predicting malignancy.
Contrast enhancement curves of CE-DBT compared to conventional MRI (arbitrary units) Calculated once all imaging is complete [Anticipated 1.5 years] To compare (using a reader study) the contrast enhancement curves of CE-DBT to the contrast enhancement curves of contrast enhanced dynamic breast MRI in evaluation of known breast lesions for predicting malignancy.
Diagnostic accuracy of CE-DBT compared to contrast enhanced dynamic breast MRI (arbitrary units) Calculated once all imaging is complete [Anticipated 1.5 years] To compare (using a reader study) the diagnostic accuracy of CE-DBT to the diagnostic accuracy of contrast enhanced dynamic breast MRI in evaluation of known breast lesions for predicting malignancy.
Specificity of CE-DBT compared to contrast enhanced dynamic breast MRI (arbitrary units) Calculated once all imaging is complete [Anticipated 1.5 years] To compare (using a reader study) the specificity of CE-DBT to the specificity of contrast enhanced dynamic breast MRI in evaluation of known breast lesions for predicting malignancy.
Positivity predictive value of CE-DBT compared to contrast enhanced dynamic breast MRI (arbitrary units) Calculated once all imaging is complete [Anticipated 1.5 years] To compare (using a reader study) the positivity predictive value of CE-DBT to the positivity predictive value of contrast enhanced dynamic breast MRI in evaluation of known breast lesions for predicting malignancy.
Receiver Operating Characteristic (ROC) curves of CE-DBT compared to contrast enhanced dynamic breast MRI (arbitrary units) Calculated once all imaging is complete [Anticipated 1.5 years] To compare (using a reader study) the ROC curves of CE-DBT to the ROC curves of contrast enhanced dynamic breast MRI in evaluation of known breast lesions for predicting malignancy.
Trial Locations
- Locations (1)
University of North Carolina at Chapel Hill
🇺🇸Chapel Hill, North Carolina, United States