Breast Cancer
Conditions
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.
Interventions
DRUGIohexol 350 Mg/mL Injectable Solution
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.
Sponsors
UNC Lineberger Comprehensive Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORRachel Hitt, MD
University of North Carolina, Chapel Hill
Outcome results
None listed