Using contrast-enhanced mammography to guide breast biopsies
Assessing the Optimal Amount of Tissue Sampling in Contrast-Enhanced Stereotactic Biopsy (CESB)
This study is testing if using a special type of mammogram to guide breast biopsies can help doctors get the right number of tissue samples needed to accurately diagnose hard-to-see breast lesions.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 150 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Zuyderland Medisch Centrum Academic / other |
| Locations | 1 site (Sittard, Limburg) |
| Trial ID | NCT06062992 on ClinicalTrials.gov |
What this trial studies
This observational study investigates the use of contrast-enhanced mammography (CEM) to guide stereotactic biopsies for breast lesions that are only visible on contrast images, known as recombined-only lesions (ROLs). The study aims to determine the minimum number of tissue samples needed to achieve a reliable diagnosis from these lesions. Participants will receive an intravenous injection of iodinated contrast agent before undergoing the biopsy procedure. The study is designed to enhance the accuracy of breast cancer diagnoses and improve patient outcomes.
Who should consider this trial
Good fit: Ideal candidates are non-pregnant women over 18 years old who have recently been diagnosed with a recombined-only lesion on a contrast-enhanced mammogram.
Not a fit: Patients who are male, pregnant, or have contraindications for contrast-enhanced stereotactic biopsy will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more accurate breast cancer diagnoses with fewer biopsies required.
How similar studies have performed: While the use of contrast-enhanced imaging in breast biopsies is emerging, this specific approach to determining tissue sampling requirements is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Women \>18 years of age; * Recent detection of a ROL on CEM; * Able to provide written informed consent. Exclusion Criteria: * All men (male sex); * Women (female sex) who are contra indicated for CESB (for example: impaired renal function, known hypersensitivity to iodinated contrast); * Pregnant women.
Where this trial is running
Sittard, Limburg
- Zuyderland Medical Center — Sittard, Limburg, Netherlands (Recruiting)
Study contacts
- Study coordinator: Marc Lobbes, MD, PhD
- Email: m.lobbes@zuyderland.nl
- Phone: +31884597777
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.