Clinical trial · Interventional
Benign-Malign Differentiation of Axillary Lymph Nodes: The Role Of Superb Microvascular Imaging
Benign-Malign Differentiation Of Axillary Lymph Nodes: The Role Of Superb Microvascular Imaging
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Axilla; Breast | — | UNRESOLVED | — |
| Diagnosis | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ultrasound and biyopsy | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Malign Group
- description
- The group includes patients who have malignant axillary lymph nodes which are proven by biopsy
- interventionNames
- Diagnostic Test: Ultrasound and biyopsy
- type
- ACTIVE_COMPARATOR
- label
- Benign Group
- description
- The group includes patients who have benign axillary lymph nodes which are proven either by biopsy or follow-up
- interventionNames
- Diagnostic Test: Ultrasound and biyopsy
Primary outcomes (3)
- measure
- The number of vascularity in both benign and malignant axillary lymph nodes
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 74 Years
Show eligibility criteria text
Inclusion Criteria: * 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. Exclusion Criteria: * 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
References
Publications (11)
- BACKGROUNDKurt 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. PMID 35943392
- BACKGROUNDUslu 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. PMID 35644841
- BACKGROUNDZhu 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. PMID 32367518
- BACKGROUNDBian 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. PMID 34160389
- BACKGROUNDKijima 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. PMID 24281030
- BACKGROUNDYang 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. PMID 10796941