An observational study in Breast Cancer, sponsored by Seoul National University Hospital. Recruiting at 1 site in Korea, Republic of. Open to female participants aged 25 Years and older. Per ClinicalTrials.gov, last updated 2024-05-29.
Sponsored by Seoul National University Hospital · Observational
Detection of multifocal, multicentric breast cancer in patients with breast cancer affects surgical decision. Histology-proven additional cancer foci have been reported to be detected in 21.0% to 63.0% of affected breasts in women thought to have localized cancer based on clinical assessment and mammography. Dynamic contrast-enhanced (DCE) MRI is often applied in the preoperative local staging of breast cancer due to its high sensitivity and identifies additional foci that would have otherwise remained undetected on clinical assessment and conventional imaging (mammography and ultrasonography). However, DCE MRI is limited in use due to its low specificity with high false positive rate, causing unnecessary and incorrect conversion to more extensive surgery. Diffusion-weighted MRI (DWI) is a fast, functional MRI technique that measures the movement of water molecules to create tissue contrast without the need for contrast injection. Breast malignancies exhibit hindered diffusion and appear hyperintense on DWI with low apparent diffusion coefficient (ADC) values compared to normal surrounding tissue or benign tumors. Multiple studies including one prospective multi-center trial showed that DWI can reduce unnecessary benign biopsies of suspicious mammographic or DCE MRI-detected lesions and DWI is now considered as an important part of multi-parametric breast MRI protocols. However, little is known about the role of DWI as an adjunct to DCE MRI in the local staging of women with breast cancer. The purpose of our study is to determine whether DWI improves the performance of preoperative DCE MRI in the evaluation of additional lesions in breast cancer patients.
Primary objective: to compare the diagnostic performance of DCE MRI vs combination of DWI and DCE MRI for detection of multifocal, multicentric breast cancer in patients planning for breast conservation surgery
Detailed Description
12,543 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's planned enrollment of 580 is above the median of 184 across 2,642 observational studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Seoul National University Hospital is the lead sponsor of 1,860 studies on the registry; 275 are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 2 (17%) have results posted.
Counted across the registry records on this site, refreshed daily.
Newly diagnosed breast cancer patients planning for breast conservation surgery
Exclusion Criteria:
Receiver operating characteristic per lesion and breast level
Area under the curve (AUC)
Time frame: 2 year after enrollment
Sensitivity per lesion and breast level
Number of positive examinations with a tissue diagnosis of cancer within 2 year/All examinations with tissue diagnosis of cancer within the same period
Time frame: 2 year after enrollment
Specificity per lesion and breast level
Number of negative examinations without tissue diagnosis of cancer within 2 year/All examinations without tissue diagnosis of cancer within the same period
Time frame: 2 year after enrollment
Positive Predictive value per lesion and breast level
True positive/True positive + False positive
Time frame: 2 year after enrollment
Characteristics of detected cancers
Tumor size, type, grade, molecular subtype, and lymph node metastasis
Time frame: 2 year after enrollment
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Seoul National University Hospital