Comparing two imaging methods for breast lesions
Comparison of Contrast Enhanced Digital Breast Tomosynthesis and Magnetic Resonance Imaging in Patients With Known Breast Lesions
EARLY_PHASE1 · UNC Lineberger Comprehensive Cancer Center · NCT05754749
This study is testing if a new type of breast imaging can do a better job than the standard MRI in checking known breast lesions in women.
Quick facts
| Phase | EARLY_PHASE1 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | UNC Lineberger Comprehensive Cancer Center (other) |
| Locations | 1 site (Chapel Hill, North Carolina) |
| Trial ID | NCT05754749 on ClinicalTrials.gov |
What this trial studies
This pilot study aims to evaluate the effectiveness of contrast enhanced digital breast tomosynthesis (CE-DBT) compared to contrast enhanced dynamic magnetic resonance imaging (CE-MRI) in assessing known breast lesions. Twenty women who have undergone or are scheduled for conventional breast MRI at UNC Hospitals will participate. Each participant will receive scans using the DBT system after an iodinated contrast agent is administered, with images taken at specific intervals. The focus will be on a single breast to streamline data collection and analysis.
Who should consider this trial
Good fit: Ideal candidates are women aged 18 and older with suspected breast lesions classified as BIRADS 4 or greater who have recently undergone or are scheduled for a breast MRI.
Not a fit: Patients with severe claustrophobia, certain implanted devices, or impaired kidney function may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the accuracy of breast lesion evaluations, leading to better patient outcomes.
How similar studies have performed: While this approach is relatively novel, similar imaging comparisons have shown promise in enhancing diagnostic confidence in breast cancer evaluations.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Chapel Hill, North Carolina
- University of North Carolina at Chapel Hill — Chapel Hill, North Carolina, United States (RECRUITING)
Study contacts
- Principal investigator: Rachel Hitt, MD — University of North Carolina, Chapel Hill
- Study coordinator: Carly Sronce, BSN, RN-BC
- Email: carly_sronce@med.unc.edu
- Phone: 919-966-3262
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Breast Cancer