Authors
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[No authors listed]
Category
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Primary study
Registry of Trials»Korean Clinical Trials Database
Year
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2023
INTERVENTION: Others( Imaging diagnostics (ultrasound and magnetic resonance imaging)) : Women are classified and randomly assigned into MRI sequence groups(1st round screening/2nd round screening : AB (abbreviated)‐MRI / FP (full protocol)‐MRI application group and FP (full protocol)‐MRI / AB (abbreviated)). MRI (either AB‐MRI or FP‐MRI) assigned as the 1st round screening (baseline), mammography, and ultrasound are performed on the same day. For the 2nd round screening one year after the 1st round screening, a different MRI (i.e., FP‐MRI if AB‐MRI was performed in the previous year, AB‐MRI if FP‐MRI was performed in the previous year), mammography, and ultrasound were performed on the same day as the 1st round screening. A patient self‐assessment result tool is developed, and after the end of the two imaging tests, individual links are sent to the subject to respond. As a reference standard, use the results of pathology tests or imaging or clinical follow‐up tests 1 year after the 2nd round screening in clinical records. CONDITION: Neoplasms PRIMARY OUTCOME: Comparison of cancer detection rate (CDR) between breast ultrasound and abbreviated magnetic resonance imaging (AB‐MRI) or breast ultrasound and full protocol magnetic resonance imaging (FP‐MRI) SECONDARY OUTCOME: Calculation of interval cancer rate Comparison of invasive cancer detection rate and abnormal interpretation rate in mammography, ultrasound, abbreviated magnetic resonance imaging (AB‐MRI), and full protocol magnetic resonance imaging (FP‐MRI) Comparison of patient self‐assessment (PRO) results between abbreviated magnetic resonance imaging (AB‐MRI) and full protocol magnetic resonance imaging (FP‐MRI) compared to ultrasound Comparison of sensitivity, specificity, positive predictive value, negative predictive value, and accuracy of each test Inferiority test between abbreviated magnetic resonance imaging (AB‐MRI) and full protocol magnetic resonance imaging (FP‐MRI) INCLUSION CRITERIA: ‐ Women aged 20‐75 with a history of breast cancer (in situ carcinoma or invasive breast cancer [stage 0‐3]) ‐ Women with a negative resection margin in the pathology results of the last surgical specimen from past breast cancer ‐ Women with dense breasts with pattern C (heterogeneously dense) or D (extremely dense breasts) using AI‐based Lunit INSIGHT for Mammography (version 1.1.4.3, Lunit Inc.) in the most recent mammography ‐ Women who have not had a breast imaging test within 6 months ‐ Women who agreed to undergo regular annual mammography, breast ultrasound, and breast MRI ‐ If mammography, ultrasound, or breast MRI was performed within the last 1 year, the most recent test result is normal or positive (BI‐RADS 1 or 2)
Epistemonikos ID: 01115afa1069d3ecc9e22fa37eff3d8b6b4a9fb7
First added on: Feb 20, 2024