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Trial Title:
Comparison of CE-DBT and MRI in Patients With Known Breast Lesions
NCT ID:
NCT05754749
Condition:
Breast Cancer
Study type:
Interventional
Study phase:
Early Phase 1
Overall status:
Active, not recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Diagnostic
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
Iohexol 350 Mg/mL Injectable Solution
Description:
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.
Arm group label:
Contrast-enhanced digital breast tomosynthesis (CE-DBT)
Other name:
Contrast- enhanced digital breast tomosynthesis (CE-DBT)
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.
Criteria for 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)
Gender:
Female
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
University of North Carolina at Chapel Hill
Address:
City:
Chapel Hill
Zip:
27599
Country:
United States
Start date:
March 13, 2023
Completion date:
August 22, 2025
Lead sponsor:
Agency:
UNC Lineberger Comprehensive Cancer Center
Agency class:
Other
Source:
UNC Lineberger Comprehensive Cancer Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05754749
