Assessing breast cancer risk using ultrasound in women with dense breasts
Association of Sonographic Glandular Tissue Component With Breast Cancer Risk Among Women With Dense Breasts: A Prospective, Multinational Validation Study
This study is testing if using ultrasound to measure glandular tissue in women with dense breasts can help predict their risk of developing breast cancer.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 16164 (estimated) |
| Ages | 40 Years to 69 Years |
| Sex | Female |
| Sponsor | Seoul National University Hospital Academic / other |
| Locations | 1 site (Seoul) |
| Trial ID | NCT05460975 on ClinicalTrials.gov |
What this trial studies
This international multicenter study aims to validate the association between sonographic glandular tissue component (GTC) and the risk of developing breast cancer in women with dense breasts. It will enroll 16,164 women aged 40 to 70 who have dense breast tissue as classified by mammography. The study will assess the amount of glandular tissue relative to fibrous stroma using breast ultrasound and will track participants for breast cancer diagnosis over time. The goal is to determine if GTC can provide additional risk assessment information beyond existing factors.
Who should consider this trial
Good fit: Ideal candidates are women aged 40 to 70 with dense breasts (BI-RADS categories C and D) and no history of breast cancer.
Not a fit: Patients with a history of breast cancer, certain surgical histories, or who are currently pregnant or breastfeeding may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance breast cancer screening and risk assessment for women with dense breasts.
How similar studies have performed: Previous studies have shown a potential link between sonographic GTC and breast cancer risk, but this study aims to prospectively validate those findings on a larger scale.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria 1. be ≥ 40 and \<70 years old at time of US 2. No history of previous breast cancer including DCIS 3. have dense breasts (BI-RADS category C and D on mammography performed within 12 months of breast US) and negative/benign BI-RADS assessment categories on mammography (BI-RADS 1, 2) 4. undergoing screening breast US using either automated or handheld device Exclusion Criteria 1. history of bilateral prophylactic mastectomy 2. history of bilateral foreign body injection 3. history of bilateral breast implants 4. history of bilateral breast reduction surgery or surgical excision 5. currently pregnant or breast feeding in the preceding 6 months 6. Known distant metastasis from other primary cancer
Where this trial is running
Seoul
- Seoul National University Hospital — Seoul, South Korea (Recruiting)
Study contacts
- Principal investigator: Woo Kyung Moon, MD, PhD — Seoul National University Hospital
- Study coordinator: Woo Kyung Moon, MD, PhD
- Email: moonwk1963@gmail.com
- 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.