Clinical trial NCT05754749: Comparison of CE-DBT and MRI in Patients With Known Breast Lesions
Official title: Comparison of Contrast Enhanced Digital Breast Tomosynthesis and Magnetic Resonance Imaging in Patients With Known Breast Lesions
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: EARLY_PHASE1
Conditions: Breast Cancer
Lead sponsor: UNC Lineberger Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2023-03-06
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Reader confidence in identifying lesions on CE-DBT compared to contrast enhanced dynamic breast MRI (arbitrary units)
timeFrame: Calculated once all imaging is complete [Anticipated 1.5 years]
Secondary outcomes:
measure: Contrast enhancement curves of CE-DBT compared to conventional MRI (arbitrary units)
timeFrame: Calculated once all imaging is complete [Anticipated 1.5 years]
measure: Diagnostic accuracy of CE-DBT compared to contrast enhanced dynamic breast MRI (arbitrary units)
timeFrame: Calculated once all imaging is complete [Anticipated 1.5 years]
measure: Sensitivity of CE-DBT compared to contrast enhanced dynamic breast MRI (arbitrary units)
timeFrame: Calculated once all imaging is complete [Anticipated 1.5 years]
measure: Specificity of CE-DBT compared to contrast enhanced dynamic breast MRI (arbitrary units)
timeFrame: Calculated once all imaging is complete [Anticipated 1.5 years]
measure: Positivity predictive value of CE-DBT compared to contrast enhanced dynamic breast MRI (arbitrary units)
timeFrame: Calculated once all imaging is complete [Anticipated 1.5 years]
measure: Receiver Operating Characteristic (ROC) curves of CE-DBT compared to contrast enhanced dynamic breast MRI (arbitrary units)
timeFrame: Calculated once all imaging is complete [Anticipated 1.5 years]
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Rachel Hitt, MD
role: PRINCIPAL_INVESTIGATOR
References: