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

Breast Cancer Clinical Trial

Official title:

Comparison of Contrast Enhanced Digital Breast Tomosynthesis and Magnetic Resonance Imaging in Patients With Known Breast Lesions

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05754749
• Other study ID #: LCCC2139
• Status: Recruiting
• Phase: Early Phase 1
• Start date: March 13, 2023
• Est. completion date: October 2024

Study information

• Verified date: April 2024
• Source: UNC Lineberger Comprehensive Cancer Center
• Contact: Carly Sronce, BSN, RN-BC
• Phone: 919-966-3262
• Email: carly_sronce[@]med.unc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: October 2024
• Est. primary completion date: October 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 ß-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)

Related Conditions & MeSH terms

• Breast Cancer

Intervention

Drug:
• Iohexol 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.

Locations

Country	Name	City	State
United States	University of North Carolina at Chapel Hill	Chapel Hill	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
UNC Lineberger Comprehensive Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reader confidence in identifying lesions on CE-DBT compared to contrast enhanced dynamic breast MRI (arbitrary units)	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.	Calculated once all imaging is complete [Anticipated 1.5 years]
Secondary	Contrast enhancement curves of CE-DBT compared to conventional MRI (arbitrary units)	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.	Calculated once all imaging is complete [Anticipated 1.5 years]
Secondary	Diagnostic accuracy of CE-DBT compared to contrast enhanced dynamic breast MRI (arbitrary units)	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.	Calculated once all imaging is complete [Anticipated 1.5 years]
Secondary	Sensitivity of CE-DBT compared to contrast enhanced dynamic breast MRI (arbitrary units)	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.	Calculated once all imaging is complete [Anticipated 1.5 years]
Secondary	Specificity of CE-DBT compared to contrast enhanced dynamic breast MRI (arbitrary units)	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.	Calculated once all imaging is complete [Anticipated 1.5 years]
Secondary	Positivity predictive value of CE-DBT compared to contrast enhanced dynamic breast MRI (arbitrary units)	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.	Calculated once all imaging is complete [Anticipated 1.5 years]
Secondary	Receiver Operating Characteristic (ROC) curves of CE-DBT compared to contrast enhanced dynamic breast MRI (arbitrary units)	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.	Calculated once all imaging is complete [Anticipated 1.5 years]