Comparing contrast-enhanced mammography for breast cancer diagnosis
The Role of Contrast-Enhanced Spectral Mammography (CESM) in the Diagnostic Process of Breast Cancer
PHASE2 · European Institute of Oncology · NCT06311695
This study is testing if contrast-enhanced mammography can better detect breast cancer in women with dense breast tissue compared to traditional methods.
Quick facts
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 263 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | European Institute of Oncology (other) |
| Locations | 1 site (Milan) |
| Trial ID | NCT06311695 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the diagnostic accuracy of contrast-enhanced mammography (CEM) in detecting breast cancer, using vacuum-assisted breast biopsy (VABB) as the reference standard. It addresses the limitations of traditional mammography, particularly in women with dense breast tissue, where sensitivity is significantly reduced. By utilizing CEM, the study seeks to improve early detection rates of breast malignancies, thereby enhancing patient outcomes. The research will involve patients with breast lesions who have undergone bilateral CEM for assessment.
Who should consider this trial
Good fit: Ideal candidates for this study are women with breast lesions who have undergone bilateral contrast-enhanced mammography.
Not a fit: Patients who are known to have adverse reactions to iodine contrast agents or have breasts too large for adequate imaging will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved early detection of breast cancer, particularly in women with dense breast tissue, ultimately enhancing survival rates.
How similar studies have performed: Other studies have shown promise in using contrast-enhanced imaging techniques for breast cancer detection, suggesting a potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients with breast lesions, who underwent bilateral CEM * Histological assessment Exclusion Criteria: * The subject is known to have risks of adverse effects with iodine contrast agents * The subject has breasts too large to be adequately positioned on Full field digital mammography (FFDM) digital receptor without anatomical cut off during an FFDM examination
Where this trial is running
Milan
- Breast Imaging Division, Radiology Department, IEO European Institute of Oncology IRCCS — Milan, Italy (RECRUITING)
Study contacts
- Principal investigator: Enrico Cassano, MD — European Institute of Oncology
- Study coordinator: Enrico Cassano, MD
- Email: enrico.cassano@ieo.it
- Phone: +390257489410
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, mammography, enhancement, Contrast Enhanced Mammography