Ignite Creation Date:
2024-05-06 @ 3:11 PM
Last Modification Date:
2024-10-26 @ 1:44 PM
Study NCT ID:
NCT04549558
Status:
UNKNOWN
Last Update Posted:
2022-03-31
First Post:
2020-09-09
Brief Title:
Multimodal Ultrasonographic Assessment of Ipsilateral Axillary Lymph Nodes in Patients With Breast Cancer A STARD Study
Sponsor:
Assiut University
Organization:
Assiut University
Study Overview
Official Title:
Multimodal Ultrasonographic Assessment of Ipsilateral Axillary Lymph Nodes in Patients With Breast Cancer A STARD Study
Status:
UNKNOWN
Status Verified Date:
2022-03
Last Known Status:
NOT_YET_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:
Breast cancer BrCa is the most common malignant neoplasm in women worldwide with a continuous rise on both its incidence and cancer-related deaths Accurate evaluation of the presence extent and status benign or malignant of axillary lymph nodes ALNs in patients with BrCa has an important prognostic value and is essential for disease staging and treatment planning Many radiological diagnostic modalities have been utilized to assess the nature of ALNs in the pre-operative stage Each modality has its weaknesses and strengths Multimodal imaging combines two or more imaging modalities into one system to produce details in clinical diagnostic imaging that are more precise than any conventional imaging alone Therefore the present study is designed to assess the role of simultaneous multi-modal sonographic tools conventional grey-scale ultrasound US Color-Doppler ultrasound CDU strain ultrasound elastography UE in evaluating the nature benign or malignant of ipsilateral ALNs in patients with primary BrCa together with comparing the diagnostic indices of each with that of all-together combined modalities A total of 30 patients with BrCa and US-visible ALNs will be included All will be subjected to simultaneous examination by US CDU UE and US-guided FNA cytology examination of their ipsilateral ALNs Data will be collected and analyzed using SPSS version 23 Area under the receiver Operating Characteristic ROC curve will be calculated and the diagnostic indices of each modality and of all modalities will be measured
Detailed Description:
BACKGROUND Breast cancer BrCa is the most common malignant neoplasm in women worldwide with a continuous rise on both its incidence and cancer-related deaths 1-3 Accurate evaluation of the presence extent and status of axillary lymph nodes ALNs in patients with BrCa has an important prognostic value and is essential for disease staging and treatment planning 4
Historically axillary lymph node dissection ALND and histopathology was used for staging BrCa but with inevitable short- and long-term complications such as lymphedema nerve injury seroma and infection 5 Afterwards sentinel lymph node SLN biopsy SLNB has gradually replaced ALND despite its invasive nature unavoidable false negative results and post-operative complication which are far less than those encountered with ALND 6 According to the American Society of Oncology Guidelines If the SLNB results are negative no further dissection is done because there is no survival benefit for performing ALND in this setting Patients with positive SLNB results traditionally undergo completion ALND 67
Grey-scale ultrasound US is a non-invasive method that plays an important role in the preoperative evaluation of ALNs and obtaining samples in patients with BrCa 8-11 Nevertheless US is operator dependent and focuses mainly on the morphological features lymph nodes LNs Addition of Color-Doppler Ultrasound CDU helps in assessing the presence and distribution of vasculature pattern as well as the resistive index RI of ALNs 11-13 Despite their promising results US and CDU studies showed very wide ranges and variations in sensitivity and specificity 8-13
Real-time strain ultrasound elastography UE is an imaging technique that utilizes the long-established clinical concept that malignant lesions are often stiffer than normal tissues The stiffness a characteristic that cant be assessed by US nor CDU 14 and the UE has therefore been utilized to assess pathological changes in many organs such as liver breast thyroid muscle Kidney Prostate and cervical LNs Nicely reviewed in 14 Additionally elastograms obtained by UE are color-coded images indicating differences in stiffness of portions of a target tissue These color maps or images arise from analysis of the changes in the radiofrequency impulses before and after the rhythmic manual compression directed along the radiation axis In addition UE images are produced simultaneously with the conventional gray-scale US to ensure that images of the same node are precisely obtained 14 UE has also been used in assessing ALNs but with variable and conflicting results 1516 Two recent meta-analyses concluded that UE can provide additive useful information regarding ALN assessment prior to surgical procedure selection 1718
Other imaging modalities such as mammography magnetic resonance imaging MRI multi-detector computed tomography CT Positron-emission tomography PET-CT were also tried but their wide use is limited by their moderate sensitivity low specificity need for special protocol for ALNs assessment law availability high cost and radiation hazard 19-25
Multimodal imaging combines two or more imaging modalities into one system to produce details in clinical diagnostic imaging that are more precise than any conventional imaging alone
AIMS The present study is designed to assess the role of simultaneous multi-modal sonographic tools US CDU UE in evaluating the nature benign or malignant of ipsilateral ALNs in patients with primary BrCa together with comparing the diagnostic indices of each with that of all-together combined modalities In other words whether adding UE to conventional grey-scale US and CDU will increase their diagnostic accuracy or not
METHODS A Type of the study A prospective cohort diagnostic hospital-based study B Study Setting Department of Diagnostic Radiology Assiut University Hospitals
C Sample Size Calculation The study will include 30 consecutive patients with primary BrCa and ipsilateral ALNs of obscure nature visible by axillary conventionalgrey-scale ultrasound US scan In Each patient one or more LN may be examined
D Study tools All participants will be subjected to the following
I Screening clinical physical and Grey-scale ultrasound examination of the axilla With patients in the supine position an experienced radiologist in conventional US CDU UE will perform the physical clinical examination using a Gray-scale digital US scanner General Electric GE USA equipped with a 75-13 MHz liner transducer will be performed first to assess for the presence of ALNs Only the ipsilateral axillary region will be evaluated
II Conventional grey-scale ultrasound US Scoring of the ALNs A gray-scale conventional US scoring system of 5 criteria will be implemented These include 1 Short-axis S diameter S 7 mm score 1 S 7 mm score 0 2 Long-to-short axis LS diameter ratio LS 2 score 1 2 score 0 3 The hilum long axis-to-node long axis HL diameter ratio HL 05 score 1 HL 05 score 0 4 Border irregular score 1 regular score 0 and 5 Cortical thickness T 3 mm score 1 T 3 mm score 0 When the node did not have a hilar region the cortical thickness will be regarded as 3 mm when the short-axis diameter is 3 mm 26 and Figure 2
III Color Doppler Ultrasound CDU examination of the ALNs After US CDU will be performed as previously described 11-13 with the following precautions 1 use of low wall filter and low velocity scale to be able to detect slow flow 2 adjust color gain to maximum to help better blood flow demonstration and avoid noise artefacts 3 place the transducer gently to avoid superficial vessels compression that may lead to an increase in vascular resistance Intra-nodal blood flow in color Doppler studies will be classified into 4 categories 1 central flow 2 peripheral flow or 3 Mixed peripheral and central 4 absent flow Central vessels are those appearing in both hilar and peri-hilar branches only Peripheral vessels are those in the periphery that have no connection with the hilar vessel Lymph nodes with both peripheral and central mixed flow will be grouped as mixed If blood vessels are detected 3 Doppler spectral waveforms will be obtained and their mean will be calculated and considered as the resistivity index RI The RI is chosen as it is not dependent on the angle of insonation and therefore it can be accurately calculated even in small vessels RI is calculated as follows RI Peak systolic velocity - end diastolic velocitypeak systolic velocity
IV Strain ultrasound elastography UE of the ALNs UE images will be evaluated with a scoring system based on the percentage and distribution of the hypoechoic cortex regions with a visible hilum in ALN Pattern I or all the hypoechoic lymph nodes with an absent hilum Pattern II
In Pattern I LN with Hila scoring will be as follows 26
1 the green portion occupied almost all of the cortex
2 the blue portion occupies 50 of the cortex
3 the blue portion occupies 50 of the cortex with scattered the green portions
4 the blue portion occupies almost all of the cortex
5 the blue portion occupies almost all of the cortex with a green ring on the edge of the node
In pattern II LN without Hila scoring will be as follows 26
1 Green portion occupying almost all of the cortex
2 Blue portion occupying less than 50 of the cortex
3 Blue portion occupying more than 50 of the cortex with a scattered green portion
4 Blue portion occupying almost all of the cortex
5 Blue portion occupying almost all of the cortex with a green ring on the edge of the node
Calculation of the Strain Ratio SR by UE The SR is a ratio between the strain value of the two regions of interest ROI A and B where ROI-A is the deepest blue portions of the hypoechoic regions within the nodes and ROI-B is the surrounding soft and adipose tissue at the same depth
SR strain value of ROI-B strain value of ROI-A Of note SR is automatically calculated by the software built into certain equipment and displayed on its monitor 26
V Combined evaluation of gray-scale US CDU and UE The score of combined evaluation for each lymph node will be the sum of the gray-scale US 5 points the CDU 1 point and the UE 5 points scores A cut-off value will be evaluated with the pathological diagnosis
VI Ultrasound-guided FNA from the ALNs After completion of the above 3 sonographic modalities examinations and under local anesthesia using 5 ml of subcutaneous 1 Xylocaine US-guided fine needle aspiration FNA will be performed by the same radiologist for all visible ALNs using 20-22 gauge needles attached to a 10 ml plastic syringe Under UE guidance the needle will be inserted into the cortex with 3 passes as routinely performed and previously described 27 When 2 or more abnormal LNs are identified the node that looks the most suspicious will be aspirated Samples will then be spread and fixed on glass-slides using 95 alcohol and air-dried for Pap Diff-Quik American Scientific Products McGraw Park IL USA staining in the Pathology Department prior to being examined The final pathological diagnosis for the LNs will be made by a pathologist blinded to the imaging findings Results of the US modalities will be correlated with the results of the FNAC
E Data Management and Statistical Analyses Data collection will be done in a preformed Data Collection Form Appendix 1 prior to being entered in Microsoft Exel 2016 Afterwards data will be exported to the Statistical Package for Social Sciences SPSS version 230 software package SPSS Inc Chicago IL USA for the statistical analysis Comparisons of numeric continuous variables and categorical variables will be done using the Wilcoxons rank sum test or Students t-test and Chi-Square or Fishers Exact test respectively and as appropriate The sensitivity specificity positive predictive value PPV negative predictive value NPV and accuracy will be calculated to compare the diagnostic performance of each modality The areas under the receiver operating characteristic ROC curves AUC will be calculated and compared using the U-test All cutoff values will be determined depending on the best accuracy identified by ROC curves A probability value of P005 will be considered Statistically significant for all tests The cytopathological diagnosis will be considered as the reference gold standard
REFERENCES
1 Siegel RL Miller KD Jemal A Cancer statistics 2019 CA Cancer J Clin 20196917-34
2 DeSantis CE Ma J Gaudet MM et al Breast cancer statistics 2019 CA Cancer J Clin 2019696438-451
3 Bray F Ferlay J Soerjomataram I et al Global cancer statistics 2018 GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries CA Cancer J Clin 201868394-424
4 Kleer CG Sabel MS Prognostic and predictive factors in breast cancer In Kuerer HM ed Kuerers breast surgical oncology New York NY McGrawHill 2010 244
5 Ivens D Hoe AL Podd TJ et al Assessment of morbidity from complete axillary dissection Br J Cancer 199266136-138
6 Lyman GH Giuliano AE Somerfield MR et al American Society of Clinical Oncology guideline recommendations for sentinel lymph node biopsy in early-stage breast cancer J Clin Oncol 200523307703-7720
7 Krag DN Anderson SJ Julian TB et al Technical outcomes of sentinel-lymph-node resection and conventional axillary-lymph-node dissection in patients with clinically node-negative breast cancer results from the NSABP B-32 randomised phase III trial Lancet Oncol 20078881-888
8 Britton PD Meroni S Moscovici OC et al Use of ultrasound-guided axillary node core biopsy in staging of early breast cancer Eur Radiol 200919561-569
9 Choi YJ Ko EY Han BK et al High-resolution ultrasonographic features of axillary lymph node metastasis in patients with breast cancer Breast 200918119-122
10 Alvarez S Añorbe E Alcorta P et al Role of sonography in the diagnosis of axillary lymph node metastases in breast cancer a systematic review Am J Roentgenol 20061861342-1348
11 Choudhary J Agrawal R Mishra A Nandwani R Ultrasound and color Doppler evaluation of axillary lymph nodes in breast carcinoma with histopathological Correlation Int J Scientific Study 201851059-66
12 Esen G Gurses B Yilmaz MH et al Gray scale and power Doppler US in the preoperative evaluation of axillary metastases in breast cancer patients with no palpable lymph nodes Eur Radiol 20051561215-1223
13 Esen G Ultrasound of superficial lymph nodes Eur J Radiol 2006583345-359
14 Sigrist RMS Liau J El Kaffas A et al Ultrasound Elastography Review of Techniques and Clinical Applications Theranostics 2017 71303-1329
15 Tsai WC Lin CK Wei HK et al Sonographic elastography improves the sensitivity and specificity of axilla sampling in breast cancer a prospective study Ultrasound Med Biol 201339941-949
16 Park YM Fornage BD Benveniste AP et al Strain elastography of abnormal axillary nodes in breast cancer patients does not improve diagnostic accuracy compared with conventional ultrasound alone AJR Am J Roentgenol 201420361371-1378
17 Wang RY Zhang YW Gao ZM Wang XM Role of sonoelastography in assessment of axillary lymph nodes in breast cancer a systematic review and meta-analysis Clin Radiol 202075320e1-320e7
18 Tang GX Xiao XY Xu XL et al Diagnostic value of ultrasound elastography for differentiation of benign and malignant axillary lymph nodes a meta-analysis Clin Radiol 202075481e9-481e16
19 Valente SA Levine GM Silverstein MJ et al Accuracy of predicting axillary lymph node positivity by physical examination mammography ultrasonography and magnetic resonance imaging Ann Surg Oncol 2012191825-1830
20 Kim WH Kim HJ Lee SM et al Preoperative axillary nodal staging with ultrasound and magnetic resonance imaging predictive values of quantitative and semantic features Br J Radiol 201891109220180507
21 Felipe VC Graziano L Barbosa PNVP et al Multidetector Computed Tomography with Dedicated Protocol for Breast Cancer Locoregional Staging Feasibility Study Diagnostics Basel 2020107479
22 Liang X Yu J Wen B et al MRI and FDG-PETCT based assessment of axillary lymph node metastasis in early breast cancer a meta-analysis Clin Radiol 2017724295-301
23 Zhang X Liu Y Luo H Zhang J PETCT and MRI for Identifying Axillary Lymph Node Metastases in Breast Cancer Patients Systematic Review and Meta-Analysis published online ahead of print 2020 Jun 21 J Magn Reson Imaging 2020101002jmri27246
24 Marino MA Avendano D Zapata P et al Lymph node imaging in patients with primary breast cancer concurrent diagnostic tools The Oncologist 202025e231-e242
25 Lowes S Leaver A Cox K et al Evolving imaging techniques for staging axillary lymph nodes in breast cancer Clin Radiol 2018734396-409
26 Xu Y Bai X Chen Y et al Application of Real-time Elastography Ultrasound in the Diagnosis of Axillary Lymph Node Metastasis in Breast Cancer Patients Sci Rep 20188110234
27 Krishnamurthy S Sneige N Bedi DG et al Role of ultrasound-guided fine-needle aspiration of indeterminate and suspicious axillary lymph nodes in the initial staging of breast carcinoma Cancer 2002955982-988
28 httpswwwwmanetpolicies-postwma-declaration-of-helsinki-ethical-principles-for-medical-research-involving-human-subjectsLast seen on 2582020
Historically axillary lymph node dissection ALND and histopathology was used for staging BrCa but with inevitable short- and long-term complications such as lymphedema nerve injury seroma and infection 5 Afterwards sentinel lymph node SLN biopsy SLNB has gradually replaced ALND despite its invasive nature unavoidable false negative results and post-operative complication which are far less than those encountered with ALND 6 According to the American Society of Oncology Guidelines If the SLNB results are negative no further dissection is done because there is no survival benefit for performing ALND in this setting Patients with positive SLNB results traditionally undergo completion ALND 67
Grey-scale ultrasound US is a non-invasive method that plays an important role in the preoperative evaluation of ALNs and obtaining samples in patients with BrCa 8-11 Nevertheless US is operator dependent and focuses mainly on the morphological features lymph nodes LNs Addition of Color-Doppler Ultrasound CDU helps in assessing the presence and distribution of vasculature pattern as well as the resistive index RI of ALNs 11-13 Despite their promising results US and CDU studies showed very wide ranges and variations in sensitivity and specificity 8-13
Real-time strain ultrasound elastography UE is an imaging technique that utilizes the long-established clinical concept that malignant lesions are often stiffer than normal tissues The stiffness a characteristic that cant be assessed by US nor CDU 14 and the UE has therefore been utilized to assess pathological changes in many organs such as liver breast thyroid muscle Kidney Prostate and cervical LNs Nicely reviewed in 14 Additionally elastograms obtained by UE are color-coded images indicating differences in stiffness of portions of a target tissue These color maps or images arise from analysis of the changes in the radiofrequency impulses before and after the rhythmic manual compression directed along the radiation axis In addition UE images are produced simultaneously with the conventional gray-scale US to ensure that images of the same node are precisely obtained 14 UE has also been used in assessing ALNs but with variable and conflicting results 1516 Two recent meta-analyses concluded that UE can provide additive useful information regarding ALN assessment prior to surgical procedure selection 1718
Other imaging modalities such as mammography magnetic resonance imaging MRI multi-detector computed tomography CT Positron-emission tomography PET-CT were also tried but their wide use is limited by their moderate sensitivity low specificity need for special protocol for ALNs assessment law availability high cost and radiation hazard 19-25
Multimodal imaging combines two or more imaging modalities into one system to produce details in clinical diagnostic imaging that are more precise than any conventional imaging alone
AIMS The present study is designed to assess the role of simultaneous multi-modal sonographic tools US CDU UE in evaluating the nature benign or malignant of ipsilateral ALNs in patients with primary BrCa together with comparing the diagnostic indices of each with that of all-together combined modalities In other words whether adding UE to conventional grey-scale US and CDU will increase their diagnostic accuracy or not
METHODS A Type of the study A prospective cohort diagnostic hospital-based study B Study Setting Department of Diagnostic Radiology Assiut University Hospitals
C Sample Size Calculation The study will include 30 consecutive patients with primary BrCa and ipsilateral ALNs of obscure nature visible by axillary conventionalgrey-scale ultrasound US scan In Each patient one or more LN may be examined
D Study tools All participants will be subjected to the following
I Screening clinical physical and Grey-scale ultrasound examination of the axilla With patients in the supine position an experienced radiologist in conventional US CDU UE will perform the physical clinical examination using a Gray-scale digital US scanner General Electric GE USA equipped with a 75-13 MHz liner transducer will be performed first to assess for the presence of ALNs Only the ipsilateral axillary region will be evaluated
II Conventional grey-scale ultrasound US Scoring of the ALNs A gray-scale conventional US scoring system of 5 criteria will be implemented These include 1 Short-axis S diameter S 7 mm score 1 S 7 mm score 0 2 Long-to-short axis LS diameter ratio LS 2 score 1 2 score 0 3 The hilum long axis-to-node long axis HL diameter ratio HL 05 score 1 HL 05 score 0 4 Border irregular score 1 regular score 0 and 5 Cortical thickness T 3 mm score 1 T 3 mm score 0 When the node did not have a hilar region the cortical thickness will be regarded as 3 mm when the short-axis diameter is 3 mm 26 and Figure 2
III Color Doppler Ultrasound CDU examination of the ALNs After US CDU will be performed as previously described 11-13 with the following precautions 1 use of low wall filter and low velocity scale to be able to detect slow flow 2 adjust color gain to maximum to help better blood flow demonstration and avoid noise artefacts 3 place the transducer gently to avoid superficial vessels compression that may lead to an increase in vascular resistance Intra-nodal blood flow in color Doppler studies will be classified into 4 categories 1 central flow 2 peripheral flow or 3 Mixed peripheral and central 4 absent flow Central vessels are those appearing in both hilar and peri-hilar branches only Peripheral vessels are those in the periphery that have no connection with the hilar vessel Lymph nodes with both peripheral and central mixed flow will be grouped as mixed If blood vessels are detected 3 Doppler spectral waveforms will be obtained and their mean will be calculated and considered as the resistivity index RI The RI is chosen as it is not dependent on the angle of insonation and therefore it can be accurately calculated even in small vessels RI is calculated as follows RI Peak systolic velocity - end diastolic velocitypeak systolic velocity
IV Strain ultrasound elastography UE of the ALNs UE images will be evaluated with a scoring system based on the percentage and distribution of the hypoechoic cortex regions with a visible hilum in ALN Pattern I or all the hypoechoic lymph nodes with an absent hilum Pattern II
In Pattern I LN with Hila scoring will be as follows 26
1 the green portion occupied almost all of the cortex
2 the blue portion occupies 50 of the cortex
3 the blue portion occupies 50 of the cortex with scattered the green portions
4 the blue portion occupies almost all of the cortex
5 the blue portion occupies almost all of the cortex with a green ring on the edge of the node
In pattern II LN without Hila scoring will be as follows 26
1 Green portion occupying almost all of the cortex
2 Blue portion occupying less than 50 of the cortex
3 Blue portion occupying more than 50 of the cortex with a scattered green portion
4 Blue portion occupying almost all of the cortex
5 Blue portion occupying almost all of the cortex with a green ring on the edge of the node
Calculation of the Strain Ratio SR by UE The SR is a ratio between the strain value of the two regions of interest ROI A and B where ROI-A is the deepest blue portions of the hypoechoic regions within the nodes and ROI-B is the surrounding soft and adipose tissue at the same depth
SR strain value of ROI-B strain value of ROI-A Of note SR is automatically calculated by the software built into certain equipment and displayed on its monitor 26
V Combined evaluation of gray-scale US CDU and UE The score of combined evaluation for each lymph node will be the sum of the gray-scale US 5 points the CDU 1 point and the UE 5 points scores A cut-off value will be evaluated with the pathological diagnosis
VI Ultrasound-guided FNA from the ALNs After completion of the above 3 sonographic modalities examinations and under local anesthesia using 5 ml of subcutaneous 1 Xylocaine US-guided fine needle aspiration FNA will be performed by the same radiologist for all visible ALNs using 20-22 gauge needles attached to a 10 ml plastic syringe Under UE guidance the needle will be inserted into the cortex with 3 passes as routinely performed and previously described 27 When 2 or more abnormal LNs are identified the node that looks the most suspicious will be aspirated Samples will then be spread and fixed on glass-slides using 95 alcohol and air-dried for Pap Diff-Quik American Scientific Products McGraw Park IL USA staining in the Pathology Department prior to being examined The final pathological diagnosis for the LNs will be made by a pathologist blinded to the imaging findings Results of the US modalities will be correlated with the results of the FNAC
E Data Management and Statistical Analyses Data collection will be done in a preformed Data Collection Form Appendix 1 prior to being entered in Microsoft Exel 2016 Afterwards data will be exported to the Statistical Package for Social Sciences SPSS version 230 software package SPSS Inc Chicago IL USA for the statistical analysis Comparisons of numeric continuous variables and categorical variables will be done using the Wilcoxons rank sum test or Students t-test and Chi-Square or Fishers Exact test respectively and as appropriate The sensitivity specificity positive predictive value PPV negative predictive value NPV and accuracy will be calculated to compare the diagnostic performance of each modality The areas under the receiver operating characteristic ROC curves AUC will be calculated and compared using the U-test All cutoff values will be determined depending on the best accuracy identified by ROC curves A probability value of P005 will be considered Statistically significant for all tests The cytopathological diagnosis will be considered as the reference gold standard
REFERENCES
1 Siegel RL Miller KD Jemal A Cancer statistics 2019 CA Cancer J Clin 20196917-34
2 DeSantis CE Ma J Gaudet MM et al Breast cancer statistics 2019 CA Cancer J Clin 2019696438-451
3 Bray F Ferlay J Soerjomataram I et al Global cancer statistics 2018 GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries CA Cancer J Clin 201868394-424
4 Kleer CG Sabel MS Prognostic and predictive factors in breast cancer In Kuerer HM ed Kuerers breast surgical oncology New York NY McGrawHill 2010 244
5 Ivens D Hoe AL Podd TJ et al Assessment of morbidity from complete axillary dissection Br J Cancer 199266136-138
6 Lyman GH Giuliano AE Somerfield MR et al American Society of Clinical Oncology guideline recommendations for sentinel lymph node biopsy in early-stage breast cancer J Clin Oncol 200523307703-7720
7 Krag DN Anderson SJ Julian TB et al Technical outcomes of sentinel-lymph-node resection and conventional axillary-lymph-node dissection in patients with clinically node-negative breast cancer results from the NSABP B-32 randomised phase III trial Lancet Oncol 20078881-888
8 Britton PD Meroni S Moscovici OC et al Use of ultrasound-guided axillary node core biopsy in staging of early breast cancer Eur Radiol 200919561-569
9 Choi YJ Ko EY Han BK et al High-resolution ultrasonographic features of axillary lymph node metastasis in patients with breast cancer Breast 200918119-122
10 Alvarez S Añorbe E Alcorta P et al Role of sonography in the diagnosis of axillary lymph node metastases in breast cancer a systematic review Am J Roentgenol 20061861342-1348
11 Choudhary J Agrawal R Mishra A Nandwani R Ultrasound and color Doppler evaluation of axillary lymph nodes in breast carcinoma with histopathological Correlation Int J Scientific Study 201851059-66
12 Esen G Gurses B Yilmaz MH et al Gray scale and power Doppler US in the preoperative evaluation of axillary metastases in breast cancer patients with no palpable lymph nodes Eur Radiol 20051561215-1223
13 Esen G Ultrasound of superficial lymph nodes Eur J Radiol 2006583345-359
14 Sigrist RMS Liau J El Kaffas A et al Ultrasound Elastography Review of Techniques and Clinical Applications Theranostics 2017 71303-1329
15 Tsai WC Lin CK Wei HK et al Sonographic elastography improves the sensitivity and specificity of axilla sampling in breast cancer a prospective study Ultrasound Med Biol 201339941-949
16 Park YM Fornage BD Benveniste AP et al Strain elastography of abnormal axillary nodes in breast cancer patients does not improve diagnostic accuracy compared with conventional ultrasound alone AJR Am J Roentgenol 201420361371-1378
17 Wang RY Zhang YW Gao ZM Wang XM Role of sonoelastography in assessment of axillary lymph nodes in breast cancer a systematic review and meta-analysis Clin Radiol 202075320e1-320e7
18 Tang GX Xiao XY Xu XL et al Diagnostic value of ultrasound elastography for differentiation of benign and malignant axillary lymph nodes a meta-analysis Clin Radiol 202075481e9-481e16
19 Valente SA Levine GM Silverstein MJ et al Accuracy of predicting axillary lymph node positivity by physical examination mammography ultrasonography and magnetic resonance imaging Ann Surg Oncol 2012191825-1830
20 Kim WH Kim HJ Lee SM et al Preoperative axillary nodal staging with ultrasound and magnetic resonance imaging predictive values of quantitative and semantic features Br J Radiol 201891109220180507
21 Felipe VC Graziano L Barbosa PNVP et al Multidetector Computed Tomography with Dedicated Protocol for Breast Cancer Locoregional Staging Feasibility Study Diagnostics Basel 2020107479
22 Liang X Yu J Wen B et al MRI and FDG-PETCT based assessment of axillary lymph node metastasis in early breast cancer a meta-analysis Clin Radiol 2017724295-301
23 Zhang X Liu Y Luo H Zhang J PETCT and MRI for Identifying Axillary Lymph Node Metastases in Breast Cancer Patients Systematic Review and Meta-Analysis published online ahead of print 2020 Jun 21 J Magn Reson Imaging 2020101002jmri27246
24 Marino MA Avendano D Zapata P et al Lymph node imaging in patients with primary breast cancer concurrent diagnostic tools The Oncologist 202025e231-e242
25 Lowes S Leaver A Cox K et al Evolving imaging techniques for staging axillary lymph nodes in breast cancer Clin Radiol 2018734396-409
26 Xu Y Bai X Chen Y et al Application of Real-time Elastography Ultrasound in the Diagnosis of Axillary Lymph Node Metastasis in Breast Cancer Patients Sci Rep 20188110234
27 Krishnamurthy S Sneige N Bedi DG et al Role of ultrasound-guided fine-needle aspiration of indeterminate and suspicious axillary lymph nodes in the initial staging of breast carcinoma Cancer 2002955982-988
28 httpswwwwmanetpolicies-postwma-declaration-of-helsinki-ethical-principles-for-medical-research-involving-human-subjectsLast seen on 2582020
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