DiagnosisNCT05927727
Benign-Malign Differentiation of Axillary Lymph Nodes: The Role Of Superb Microvascular Imaging
A study testing Ultrasound and biyopsy in people with Diagnosis and Axilla; Breast, run by Ankara Education and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
102 patients who have suspicious ALNs were included in our prospective study, which was approved by a tertiary health care facility ethics committee. Each suspicious lymph nodes (LNs) were examined with PDUS and SMI in terms of distribution, appearance and number of vascular structures and the still images were… Read more about this study
- Who is it for?
- Ages 18 to 74 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Diagnosis, Axilla; Breast
- What is being tested?
- Ultrasound and biyopsy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2021to 30 May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 74 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 18 years or older
- Female gender,
- Sign the informed consent form,
- No history of axillary lymph node metastasis histopathologically,
- No history of received chemotherapy or radiotherapy to the axillary region before,
- No history of axillary lymph node dissection
- No active infection in the axillary region.
Who cannot join
- Male patients,
- Under the age of 18,
- No history of histopathologically confirmed axillary lymph node metastasis,
- No history of chemotherapy or radiotherapy to the axillary region,
- Refuse to sign informed consent form
- Unavailable pathological result
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara Education and Research Hospital
Ankara, 06230
About this study
Official title: Benign-Malign Differentiation Of Axillary Lymph Nodes: The Role Of Superb Microvascular Imaging
102 patients who have suspicious ALNs were included in our prospective study, which was approved by a tertiary health care facility ethics committee. Each suspicious lymph nodes (LNs) were examined with PDUS and SMI in terms of distribution, appearance and number of vascular structures and the still images were stored. Subsequently, imaging findings were re-evaluated after histopathological or follow-up results and were compared between benign and malign groups. In addition, we revealed the diagnostic perfomance of using the each possible combination of these features in PDUS and SMI. Finally, two radiologists with 22 years and 4 years of experience analyzed the images and interobserver agreement was assessed
Read the detailed description
MATERIAL AND METHOD Patient The hospital's ethics committee approved this single-center prospective study (E-93471371-514.10). 139 female patients, ages 18 to 74, who had suspicious lymph nodes in the axilla during a breast ultrasound examination at our clinic between April 2021 and April 2022 were included in the study. 20 patients did not come back for follow-ups, 4 patients' ultrasonographic images were not sufficient diagnostic quality, and 13 patients were excluded from the study because the biopsy result was not diagnostic and the patient did not undergo re-biopsy. As a result, 108 lymph nodes from 102 patients were included in the study, and 37 patients were excluded.
Patients who were male, under the age of 18, underwent axillary lymph node dissection, had active infection in the axillary region, were diagnosed with histopathologically confirmed axillary lymph node metastasis, had received known chemotherapy or radiotherapy to the axillary region, or did not sign the informed consent form were excluded from the study. Patients who had their pathology results unavailable or who later decided not to participate in the study were also excluded.
Ultrasonographic Evaluation Suspicious axillary lymph nodes in the patients included in the study were evaluated with Toshiba Aplio a (Toshiba Medical Systems Corporation, Tokyo, Japan) ultrasound (US) device and 14-18 MHz high frequency linear probe. Gray scale US, PDUS and SMI images of the lymph nodes were stored. PRF and gain settings were adjusted to prevent from artifacts and to obtain the highest amount of signal while images were taken. In both Doppler methods, these parameters remained unchanged. The routine examination time for each patient extended 1-2 minutes by the SMI evaluation. At the end of the evaluation, a histological assessment using a 21G fine needle aspiration (FNA) biopsy or core biopsy (16-18G) from the relevant lymph nodes, or follow-up with US was performed, depending on the clinical suspicion. Any lymph nodes that regressed or disappeared throughout the US follow-up period of 1-3 months were considered benign. The lymph nodes that remained stable or progressed were evaluated through histopathological sampling. In case of non-diagnostic biopsy, patients were recalled and FNA/core biopsy was repeated. Cytology and pathology specimens were evaluated by a pathologist with at least 10 years of experience. Before the histopathological diagnosis, all patients were prospectively evaluated with ultrasonography by a radiologist blinded to the patient's clinic and history, and images were taken. After the pathology results, PDUS and SMI images were re-evaluated and the findings were compared with each other and pathology results. Finally, two radiologists with 22 years and 4 years of experience evaluated the images in terms of separately determined features without knowing the patient's clinical information and pathology result. The results were compared with each other in order to assess interobserver agreement.
Both PDUS and SMI assessed vascular patterns based on the number of internal vessels, the distribution (avascular/central/peripheral/mixed) and appearance (normal, dysplasic, avascular) of internal vessels. On SMI, both monochrome (mSMI) and color (cSMI) images were assessed. If there was diffuse cortical thickening of the lymph node, the entire cortex was included the images. Likewise if there was an asymmetric cortical thickening, images focused on that part.
Cortical flow signals were taken into account while internal vascularity was quantified. The lymph nodes with no vascular signals in the cortex were classified as avascular, the nodes with peripheral vascular signals as peripheral, the nodes with vascular signals extending from the hilus to the cortex as central, and the nodes with vascular signals in both the periphery and the central as mixed. To evaluate the morphology of the vessels, the signals with smooth, symmetrical hilar extension were considered as normal, the eccentric signals were identified as diplasic, and the lymph nodes without a signal were regarded as avascular.
Statistical Analysis In the study, mean and standard deviation were used for continuous variables, while frequency and percentage values were used when specifying categorical variables. The Kolmogorov-Smirnov and Shapiro Wilk test was used to evaluate the homogeneity of the patient distribution. Student t-test and Mann Whitney U test were used for continuous variables. Chi-square test or Fisher's exact chi-square test was used to evaluate categorical features In order to evaluate the diagnostic performance of each investigated feature of Doppler methods in the differentiation of benign and malignant lymph nodes, the area under the curve (AUC) was calculated separately by receiver operating characteristic (ROC) analysis, depending on whether they were used individually or together. Logistic regression analysis was used to determine the significance value when the features were used together. In addition, sensitivity, specificity, positive predictive value(PPV), negative predictive value (NPV) and accuracy of each method were evaluated.
The Kohen Kappa test was used for categorical features in both SMI and PDUS to assess interobserver agreement. Intragroup correlation coefficient test was used to compare vascular numbers. Chi-square test or Fisher's exact chi-square test was used to evaluate vascular properties between benign and malignant categories after consensus.
All statistical analyses was performed with SPSS version 25.0 (IBM Corp. Armonk, NY: USA. Released 2017). P value <0.05 was considered statistically significant.
- Conditions
- Diagnosis, Axilla; Breast
- Being tested
- Ultrasound and biyopsy
- Keywords
- Axilla, Lymph node, Ultrasound, Doppler, Malignancy, SMI, PDUS
- Medical subject headings
- Disease, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound and biyopsyDiagnostic test
Each participant has undergone to ultrasound and biopsy procedure if they have suspicious lymph node in axillar region
| Study group | Role | What they receive |
|---|---|---|
| Malign Group | Active comparator | The group includes patients who have malignant axillary lymph nodes which are proven by biopsy Receives: Diagnostic Test: Ultrasound and biyopsy |
| Benign Group | Active comparator | The group includes patients who have benign axillary lymph nodes which are proven either by biopsy or follow-up Receives: Diagnostic Test: Ultrasound and biyopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of vascularity in both benign and malignant axillary lymph nodes
The number of vascularity in axillary lymph nodes are assessed via inspection of the images of Superb Microvascular Imaging and Power Doppler Ultrasound by observers. Countable vascular signals are noted for each lymph nodes
Measured: Up to three months
The distribution of vessels in both benign and malignant axillary lymph nodes
Vascular distributions in axillary lymph nodes are assessed via inspection of the images of Superb Microvascular Imaging and Power Doppler Ultrasound by observers and are categorized as avascular, central, peripheral and mix.
Measured: Up to three months
The appearance of vessels in both benign and malignant axillary lymph nodes
Vascular appearance in axillary lymph nodes are assessed via inspection of the images of Superb Microvascular Imaging and Power Doppler Ultrasound by observers and are categorized as normal/central,eccentric, avascular.
Measured: Up to three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2023
- Study start1 Apr 2021
- Primary completion1 Apr 2022
- Study completion30 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for DiagnosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara Education and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Oguzhan Tokur, Ankara Education and Research Hospital
- Investigators
- Pelin Seher Oztekin, Assoc. Prof., Study director, Ankara Education and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05927727
- Sponsor's protocol ID
- Oguzhan Tokur
- Status last verified
- Jun 2023
- First submitted
- 28 Nov 2022
- Last updated
- 3 Jul 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kurt SA, Eryurekli AE, Kayadibi Y, Samanci C, Velidedeoglu M, Onur I, Arslan S, Taskin F. Diagnostic Performance of Superb Microvascular Imaging in Differentiating Benign and Malignant Axillary Lymph Nodes. Ultrasound Q. 2023 Jun 1;39(2):74-80. doi: 10.1097/RUQ.0000000000000617.
PubMed 35943392Uslu H, Tosun M. The benefit of superb microvascular imaging and shear wave elastography in differentiating metastatic axillary lymphadenopathy from lymphadenitis. Clin Breast Cancer. 2022 Aug;22(6):515-520. doi: 10.1016/j.clbc.2022.03.008. Epub 2022 May 6.
PubMed 35644841Zhu AQ, Li XL, An LW, Guo LH, Fu HJ, Sun LP, Xu HX. Predicting Axillary Lymph Node Metastasis in Patients With Breast Invasive Ductal Carcinoma With Negative Axillary Ultrasound Results Using Conventional Ultrasound and Contrast-Enhanced Ultrasound. J Ultrasound Med. 2020 Oct;39(10):2059-2070. doi: 10.1002/jum.15314. Epub 2020 May 5.
PubMed 32367518Bian J, Zhang J, Hou X. Diagnostic accuracy of ultrasound shear wave elastography combined with superb microvascular imaging for breast tumors: A protocol for systematic review and meta-analysis. Medicine (Baltimore). 2021 Jun 25;100(25):e26262. doi: 10.1097/MD.0000000000026262.
PubMed 34160389Kijima Y, Yoshinaka H, Hirata M, Mizoguchi T, Ishigami S, Nakajo A, Arima H, Ueno S, Natsugoe S. Number of Axillary Lymph Node Metastases Determined by Preoperative Ultrasound is Related to Prognosis in Patients with Breast Cancer. Cancers (Basel). 2010 Feb 4;2(1):20-31. doi: 10.3390/cancers2010020.
PubMed 24281030Yang WT, Chang J, Metreweli C. Patients with breast cancer: differences in color Doppler flow and gray-scale US features of benign and malignant axillary lymph nodes. Radiology. 2000 May;215(2):568-73. doi: 10.1148/radiology.215.2.r00ap20568.
PubMed 10796941Fu Z, Zhang J, Lu Y, Wang S, Mo X, He Y, Wang C, Chen H. Clinical Applications of Superb Microvascular Imaging in the Superficial Tissues and Organs: A Systematic Review. Acad Radiol. 2021 May;28(5):694-703. doi: 10.1016/j.acra.2020.03.032. Epub 2020 May 5.
PubMed 32418782Ryoo I, Suh S, You SH, Seol HY. Usefulness of Microvascular Ultrasonography in Differentiating Metastatic Lymphadenopathy from Tuberculous Lymphadenitis. Ultrasound Med Biol. 2016 Sep;42(9):2189-95. doi: 10.1016/j.ultrasmedbio.2016.05.012. Epub 2016 Jun 25.
PubMed 27353493Esen G, Gurses B, Yilmaz MH, Ilvan S, Ulus S, Celik V, Farahmand M, Calay OO. Gray scale and power Doppler US in the preoperative evaluation of axillary metastases in breast cancer patients with no palpable lymph nodes. Eur Radiol. 2005 Jun;15(6):1215-23. doi: 10.1007/s00330-004-2605-9. Epub 2005 Feb 3.
PubMed 15690206Ying M, Ahuja A, Brook F. Accuracy of sonographic vascular features in differentiating different causes of cervical lymphadenopathy. Ultrasound Med Biol. 2004 Apr;30(4):441-7. doi: 10.1016/j.ultrasmedbio.2003.12.009.
PubMed 15121245Sim JK, Lee JY, Hong HS. Differentiation Between Malignant and Benign Lymph Nodes: Role of Superb Microvascular Imaging in the Evaluation of Cervical Lymph Nodes. J Ultrasound Med. 2019 Nov;38(11):3025-3036. doi: 10.1002/jum.15010. Epub 2019 Apr 3.
PubMed 30945325
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Benign-Malign Differentiation Of Axillary Lymph Nodes: The Role Of Superb Microvascular Imaging
- ClinicalTrials.gov ID
- NCT05927727
- Acronym / sponsor ID
- Oguzhan Tokur
- Conditions
- Diagnosis, Axilla; Breast
- Keywords
- Axilla, Lymph node, Ultrasound, Doppler, Malignancy, SMI, PDUS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Ankara Education and Research HospitalOther government
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 1 Apr 2022 (actual)
- Study completion
- 30 May 2023 (actual)
- First posted
- 3 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
102 patients who have suspicious ALNs were included in our prospective study, which was approved by a tertiary health care facility ethics committee. Each suspicious lymph nodes (LNs) were examined with PDUS and SMI in terms of distribution, appearance and number of vascular structures and the still images were stored. Subsequently, imaging findings were re-evaluated after histopathological or follow-up results and were compared between benign and malign groups. In addition, we revealed the diagnostic perfomance of using the each possible combination of these features in PDUS and SMI. Finally, two radiologists with 22 years and 4 years of experience analyzed the images and interobserver agreement was assessed
Detailed description
MATERIAL AND METHOD Patient The hospital's ethics committee approved this single-center prospective study (E-93471371-514.10). 139 female patients, ages 18 to 74, who had suspicious lymph nodes in the axilla during a breast ultrasound examination at our clinic between April 2021 and April 2022 were included in the study. 20 patients did not come back for follow-ups, 4 patients' ultrasonographic images were not sufficient diagnostic quality, and 13 patients were excluded from the study because the biopsy result was not diagnostic and the patient did not undergo re-biopsy. As a result, 108 lymph nodes from 102 patients were included in the study, and 37 patients were excluded.
Patients who were male, under the age of 18, underwent axillary lymph node dissection, had active infection in the axillary region, were diagnosed with histopathologically confirmed axillary lymph node metastasis, had received known chemotherapy or radiotherapy to the axillary region, or did not sign the informed consent form were excluded from the study. Patients who had their pathology results unavailable or who later decided not to participate in the study were also excluded.
Ultrasonographic Evaluation Suspicious axillary lymph nodes in the patients included in the study were evaluated with Toshiba Aplio a (Toshiba Medical Systems Corporation, Tokyo, Japan) ultrasound (US) device and 14-18 MHz high frequency linear probe. Gray scale US, PDUS and SMI images of the lymph nodes were stored. PRF and gain settings were adjusted to prevent from artifacts and to obtain the highest amount of signal while images were taken. In both Doppler methods, these parameters remained unchanged. The routine examination time for each patient extended 1-2 minutes by the SMI evaluation. At the end of the evaluation, a histological assessment using a 21G fine needle aspiration (FNA) biopsy or core biopsy (16-18G) from the relevant lymph nodes, or follow-up with US was performed, depending on the clinical suspicion. Any lymph nodes that regressed or disappeared throughout the US follow-up period of 1-3 months were considered benign. The lymph nodes that remained stable or progressed were evaluated through histopathological sampling. In case of non-diagnostic biopsy, patients were recalled and FNA/core biopsy was repeated. Cytology and pathology specimens were evaluated by a pathologist with at least 10 years of experience. Before the histopathological diagnosis, all patients were prospectively evaluated with ultrasonography by a radiologist blinded to the patient's clinic and history, and images were taken. After the pathology results, PDUS and SMI images were re-evaluated and the findings were compared with each other and pathology results. Finally, two radiologists with 22 years and 4 years of experience evaluated the images in terms of separately determined features without knowing the patient's clinical information and pathology result. The results were compared with each other in order to assess interobserver agreement.
Both PDUS and SMI assessed vascular patterns based on the number of internal vessels, the distribution (avascular/central/peripheral/mixed) and appearance (normal, dysplasic, avascular) of internal vessels. On SMI, both monochrome (mSMI) and color (cSMI) images were assessed. If there was diffuse cortical thickening of the lymph node, the entire cortex was included the images. Likewise if there was an asymmetric cortical thickening, images focused on that part.
Cortical flow signals were taken into account while internal vascularity was quantified. The lymph nodes with no vascular signals in the cortex were classified as avascular, the nodes with peripheral vascular signals as peripheral, the nodes with vascular signals extending from the hilus to the cortex as central, and the nodes with vascular signals in both the periphery and the central as mixed. To evaluate the morphology of the vessels, the signals with smooth, symmetrical hilar extension were considered as normal, the eccentric signals were identified as diplasic, and the lymph nodes without a signal were regarded as avascular.
Statistical Analysis In the study, mean and standard deviation were used for continuous variables, while frequency and percentage values were used when specifying categorical variables. The Kolmogorov-Smirnov and Shapiro Wilk test was used to evaluate the homogeneity of the patient distribution. Student t-test and Mann Whitney U test were used for continuous variables. Chi-square test or Fisher's exact chi-square test was used to evaluate categorical features In order to evaluate the diagnostic performance of each investigated feature of Doppler methods in the differentiation of benign and malignant lymph nodes, the area under the curve (AUC) was calculated separately by receiver operating characteristic (ROC) analysis, depending on whether they were used individually or together. Logistic regression analysis was used to determine the significance value when the features were used together. In addition, sensitivity, specificity, positive predictive value(PPV), negative predictive value (NPV) and accuracy of each method were evaluated.
The Kohen Kappa test was used for categorical features in both SMI and PDUS to assess interobserver agreement. Intragroup correlation coefficient test was used to compare vascular numbers. Chi-square test or Fisher's exact chi-square test was used to evaluate vascular properties between benign and malignant categories after consensus.
All statistical analyses was performed with SPSS version 25.0 (IBM Corp. Armonk, NY: USA. Released 2017). P value <0.05 was considered statistically significant.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Malign Group | Active comparator | Diagnostic Test: Ultrasound and biyopsyThe group includes patients who have malignant axillary lymph nodes which are proven by biopsy |
| Benign Group | Active comparator | Diagnostic Test: Ultrasound and biyopsyThe group includes patients who have benign axillary lymph nodes which are proven either by biopsy or follow-up |
Who may qualify
- Ages
- 18 to 74 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 18 years or older
- Female gender,
- Sign the informed consent form,
- No history of axillary lymph node metastasis histopathologically,
- No history of received chemotherapy or radiotherapy to the axillary region before,
Key exclusion criteria (6 listed)
- Male patients,
- Under the age of 18,
- No history of histopathologically confirmed axillary lymph node metastasis,
- No history of chemotherapy or radiotherapy to the axillary region,
- Refuse to sign informed consent form
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultrasound and biyopsyEach participant has undergone to ultrasound and biopsy procedure if they have suspicious lymph node in axillar region | Diagnostic test | Benign Group, Malign Group |
Primary outcome
The number of vascularity in both benign and malignant axillary lymph nodes
Time frame: Up to three months
The number of vascularity in axillary lymph nodes are assessed via inspection of the images of Superb Microvascular Imaging and Power Doppler Ultrasound by observers. Countable vascular signals are noted for each lymph nodes
The distribution of vessels in both benign and malignant axillary lymph nodes
Time frame: Up to three months
Vascular distributions in axillary lymph nodes are assessed via inspection of the images of Superb Microvascular Imaging and Power Doppler Ultrasound by observers and are categorized as avascular, central, peripheral and mix.
The appearance of vessels in both benign and malignant axillary lymph nodes
Time frame: Up to three months
Vascular appearance in axillary lymph nodes are assessed via inspection of the images of Superb Microvascular Imaging and Power Doppler Ultrasound by observers and are categorized as normal/central,eccentric, avascular.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2023.
- Background: PubMed 35943392Kurt SA, Eryurekli AE, Kayadibi Y, Samanci C, Velidedeoglu M, Onur I, Arslan S, Taskin F. Diagnostic Performance of Superb Microvascular Imaging in Differentiating Benign and Malignant Axillary Lymph Nodes. Ultrasound Q. 2023 Jun 1;39(2):74-80. doi: 10.1097/RUQ.0000000000000617.
- Background: PubMed 35644841Uslu H, Tosun M. The benefit of superb microvascular imaging and shear wave elastography in differentiating metastatic axillary lymphadenopathy from lymphadenitis. Clin Breast Cancer. 2022 Aug;22(6):515-520. doi: 10.1016/j.clbc.2022.03.008. Epub 2022 May 6.
- Background: PubMed 32367518Zhu AQ, Li XL, An LW, Guo LH, Fu HJ, Sun LP, Xu HX. Predicting Axillary Lymph Node Metastasis in Patients With Breast Invasive Ductal Carcinoma With Negative Axillary Ultrasound Results Using Conventional Ultrasound and Contrast-Enhanced Ultrasound. J Ultrasound Med. 2020 Oct;39(10):2059-2070. doi: 10.1002/jum.15314. Epub 2020 May 5.
- Background: PubMed 34160389Bian J, Zhang J, Hou X. Diagnostic accuracy of ultrasound shear wave elastography combined with superb microvascular imaging for breast tumors: A protocol for systematic review and meta-analysis. Medicine (Baltimore). 2021 Jun 25;100(25):e26262. doi: 10.1097/MD.0000000000026262.
- Background: PubMed 24281030Kijima Y, Yoshinaka H, Hirata M, Mizoguchi T, Ishigami S, Nakajo A, Arima H, Ueno S, Natsugoe S. Number of Axillary Lymph Node Metastases Determined by Preoperative Ultrasound is Related to Prognosis in Patients with Breast Cancer. Cancers (Basel). 2010 Feb 4;2(1):20-31. doi: 10.3390/cancers2010020.
- Background: PubMed 10796941Yang WT, Chang J, Metreweli C. Patients with breast cancer: differences in color Doppler flow and gray-scale US features of benign and malignant axillary lymph nodes. Radiology. 2000 May;215(2):568-73. doi: 10.1148/radiology.215.2.r00ap20568.
- Background: PubMed 32418782Fu Z, Zhang J, Lu Y, Wang S, Mo X, He Y, Wang C, Chen H. Clinical Applications of Superb Microvascular Imaging in the Superficial Tissues and Organs: A Systematic Review. Acad Radiol. 2021 May;28(5):694-703. doi: 10.1016/j.acra.2020.03.032. Epub 2020 May 5.
- Background: PubMed 27353493Ryoo I, Suh S, You SH, Seol HY. Usefulness of Microvascular Ultrasonography in Differentiating Metastatic Lymphadenopathy from Tuberculous Lymphadenitis. Ultrasound Med Biol. 2016 Sep;42(9):2189-95. doi: 10.1016/j.ultrasmedbio.2016.05.012. Epub 2016 Jun 25.
- Background: PubMed 15690206Esen G, Gurses B, Yilmaz MH, Ilvan S, Ulus S, Celik V, Farahmand M, Calay OO. Gray scale and power Doppler US in the preoperative evaluation of axillary metastases in breast cancer patients with no palpable lymph nodes. Eur Radiol. 2005 Jun;15(6):1215-23. doi: 10.1007/s00330-004-2605-9. Epub 2005 Feb 3.
- Background: PubMed 15121245Ying M, Ahuja A, Brook F. Accuracy of sonographic vascular features in differentiating different causes of cervical lymphadenopathy. Ultrasound Med Biol. 2004 Apr;30(4):441-7. doi: 10.1016/j.ultrasmedbio.2003.12.009.
- Results publication: PubMed 30945325Sim JK, Lee JY, Hong HS. Differentiation Between Malignant and Benign Lymph Nodes: Role of Superb Microvascular Imaging in the Evaluation of Cervical Lymph Nodes. J Ultrasound Med. 2019 Nov;38(11):3025-3036. doi: 10.1002/jum.15010. Epub 2019 Apr 3.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pelin Seher Oztekin, Assoc. Prof. study director
Ankara Education and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound and biyopsy in people with Diagnosis and Axilla; Breast, run by Ankara Education and Research Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The number of vascularity in both benign and malignant axillary lymph nodes (time frame: Up to three months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05927727, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2023.