Ignite Creation Date:
2024-05-06 @ 3:22 PM
Last Modification Date:
2024-10-26 @ 1:48 PM
Study NCT ID:
NCT04607473
Status:
UNKNOWN
Last Update Posted:
2020-10-30
First Post:
2020-10-18
Brief Title:
ABUS for Early-stage Breast Cancer
Sponsor:
Samsung Medical Center
Organization:
Samsung Medical Center
Study Overview
Official Title:
Comparison of ABUS and HHUS in Preoperative Evaluation of Patients With Early-stage Breast Cancers
Status:
UNKNOWN
Status Verified Date:
2020-10
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
While the role of automated breast ultrasound ABUS as an alternative to hand-held ultrasound HHUS in breast cancer screening has been established the use of ABUS in preoperative evaluation of newly diagnosed breast cancer patients is still limited This may be because axillary areas are not included in the scanning area of ABUS Newly diagnosed breast cancer patients have undergone axillary US to predict axillary lymph node metastasis before surgery in combination with preoperative breast US in many institutions However recent studies have reported that sentinel lymph node biopsy alone is sufficient for diagnosis and treatment of axillae of patients with early-stage breast cancer because the incidence of axillary lymph node metastasis is very low Therefore the clinical significance of preoperative axillary US is being lowered in patients with early-stage breast cancers Thus considering that coronal images provided by ABUS may be more advantageous for detection of multifocal or multicentric cancer we hypothesized that ABUS could replace HHUS in preoperative staging of patients with early-stage breast cancers clinical Tis T1-2N0 cancers for whom preoperative axillary US is not necessary The purpose of this study was to prospectively compare the diagnostic performances of ABUS and HHUS in preoperative evaluation of patients with early-stage breast cancers This study will be conducted with institutional review board approval and written informed consent will be obtained From the Jan 2019 to Dec 2021 675 patients diagnosed with early-stage breast cancer will be enrolled from the three institutions Both ABUS and HHUS will be performed on each patient before surgery Breast radiologists independently review ABUS and HHUS images They detect all visible lesions and record the location and size of them They characterize all detected lesions by using BI-RADS category The primary object is to compare the diagnostic performance of ABUS and HHUS as preoperative staging tool in women with known breast cancers The sensitivities and specificity of each US mode for the detection of breast cancers are calculated on a per-lesion basis McNemars test and Fishers exact test are used to compare the sensitivities and PPVs for ABUS and HHUS Significance testing on the lesion level and patient level is conducted using generalized estimating equations GEEs with a logit link and an independent working correlation structure to adjust the effect of clustering on radiologists and patients GEEs are utilized to compare the sensitivities and PPVs for ABUS and HHUS Diagnostic performance are assessed with receiver operating characteristics curve analysis Area under the curves are calculated from both parametric and trapezoidal curve fitting Agreements between tumor size measured by each US mode and pathologic the tumor size are analyzed with the intraclass correlation coefficient ICC and 95 Bland-Altman limits of agreement
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None