Screening for hidden breast cancers in women with newly diagnosed breast cancer
Diffusion-Weighted MRI for Screening Contralateral Breast Cancers in Patients With Newly Diagnosed Breast Cancer
This study is testing advanced imaging techniques to see if they can find hidden breast cancers in women who have just been diagnosed with breast cancer.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1098 (estimated) |
| Ages | 25 Years to 80 Years |
| Sex | Female |
| Sponsor | Seoul National University Hospital Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Seoul) |
| Trial ID | NCT05307757 on ClinicalTrials.gov |
What this trial studies
This observational study aims to identify synchronous contralateral breast cancer in women who have recently been diagnosed with invasive breast cancer. By utilizing advanced imaging techniques such as dynamic contrast-enhanced MRI (DCE MRI) and diffusion-weighted imaging (DWI) at a 3T MR scanner, the study will assess the effectiveness of these methods in detecting cancers that may not be visible through conventional imaging. A total of 1,098 women will be enrolled, and the results will be compared against pathology findings from biopsies and follow-up assessments over two years. The goal is to improve early detection and potentially reduce the need for additional cancer therapies.
Who should consider this trial
Good fit: Ideal candidates are women over 25 years old with newly diagnosed invasive breast cancer who are planning for breast conservation surgery.
Not a fit: Patients with ductal carcinoma in situ, recurrent breast cancer, or those who have undergone lumpectomy prior to MRI may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to earlier detection of contralateral breast cancers, improving treatment outcomes for patients.
How similar studies have performed: Previous studies have shown that advanced MRI techniques can improve detection rates of breast cancers, suggesting a promising approach in this area.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Women aged more than 25 years at the time of enrollment * Women underwent digital mammography and whole-breast US before MRI * Women with image-guided biopsy result of invasive breast cancer * Women who are planning for breast conservation surgery * Women who will undergo preoperative breast MRI Exclusion Criteria: 1. Women aged less than 25 years at the time of enrollment 2. Women with image-guided biopsy result of ductal carcinoma in situ or recurrent breast cancer 3. Women who underwent lumpectomy before MRI 4. Women receiving neoadjuvant chemotherapy or undergoing chemotherapy due to other malignancy 5. Pregnant or lactating women 6. Women with contraindication to breast MRI (claustrophobia, renal insufficiency GFR \<60mL/min/1.73m2, metallic foreign body, history of severe side effects due to MR contrast agent, who cannot tolerate 40 minute scanning time etc).
Where this trial is running
Seoul
- Seoul National University Hospital — Seoul, South Korea (Recruiting)
Study contacts
- Study coordinator: Woo Kyung Moon, MD, PhD
- Email: moonwk@snu.ac.kr
- Phone: +82220722584
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.