None listed
Conditions
Interventions
None listed
Sponsors
Asan Medical Center
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Women aged between 30 and 75 years 2. Women with a personal history of surgery for ductal carcinoma in situ or invasive breast cancer 3. Clinically asymptomatic women without signs or symptoms suspicious for breast cancer recurrence at the time of enrollment (e.g., palpable mass, nipple discharge) 4. Women scheduled to undergo standard post-surgical screening examinations, including full-field digital mammography (FFDM) and breast ultrasound (US) 5. Women whose final surgical margins were negative, defined as no ink on tumor 6. Women who completed radiation therapy at least 6 months prior to study enrollment, if applicable 7. Women with no history of breast surgery or biopsy within 6 months prior to study enrollment 8. Women with no prior screening using breast MRI, breast ultrasound, or mammography within 6 months before study enrollment 9. Women with no known distant metastasis at the time of enrollment 10. Women who provided written informed consent after receiving adequate explanation of the study purpose and procedures
Exclusion criteria
Exclusion criteria: 1. Male patients 2. Presence of clinical signs or symptoms suspicious for breast cancer recurrence at the time of enrollment (e.g., palpable mass, nipple discharge) 3. Women who are currently pregnant or breastfeeding, or who plan to become pregnant within 3 years 4. Patients who have undergone or are scheduled to undergo breast MRI or molecular breast imaging (MBI) within 1 year before or after study enrollment 5. Patients who have undergone bilateral total mastectomy 6. Patients diagnosed with secondary breast cancer or with locoregional recurrence or distant metastasis 7. Patients currently receiving systemic chemotherapy for another type of malignancy 8. Contraindications to intravenous administration of iodinated contrast media, including: 1) History of hypersensitivity or allergic reaction to iodinated contrast agents 2) Severe renal dysfunction (serum creatinine =1.3 mg/dL or estimated glomerular filtration rate [eGFR] <45 mL/min/1.73 m²)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cancer detection rate (CDR) of contrast-enhanced mammography (CEM) and breast ultrasound (US) | — |
Secondary
| Measure | Time frame |
|---|---|
| Sensitivity of contrast-enhanced mammography (CEM) and breast ultrasound (US);Specificity of contrast-enhanced mammography (CEM) and breast ultrasound (US);Positive predictive value for biopsy (PPV3) following contrast-enhanced mammography (CEM) and breast ultrasound (US);Recall rate after contrast-enhanced mammography (CEM) and breast ultrasound (US);Patient preference related to contrast-enhanced mammography and breast ultrasound examinations | — |
Countries
Korea, Republic of
Contacts
Public ContactKyunghyun Jung
Asan Medical Center
Outcome results
None listed