Benign-Malign Differentiation of Axillary Lymph Nodes: The Role Of Superb Microvascular Imaging

NCT05927727 | Completed

• 1 other identifier: Oguzhan Tokur
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

Brief 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 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

Diagnosis; Axilla; Breast

Keywords

Axilla; Lymph node; Ultrasound; Doppler; Malignancy; SMI; PDUS

Outcome Measures

Primary Outcomes (3)

• 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

  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.

  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.

  Up to three months

Study Arms (2)

Malign Group

ACTIVE COMPARATOR

The group includes patients who have malignant axillary lymph nodes which are proven by biopsy

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

Diagnostic Test: Ultrasound and biyopsy

Interventions

Ultrasound and biyopsy DIAGNOSTIC_TEST

Each participant has undergone to ultrasound and biopsy procedure if they have suspicious lymph node in axillar region

Benign Group; Malign Group

Eligibility Criteria

• Age: 18 Years - 74 Years
• Gender Eligibility Details: Female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Ankara Education and Research Hospital: lead

Study Sites (1)

Ankara Education and Research Hospital

Ankara, 06230, Turkey (Türkiye)

Location

Related Publications (11)

• 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.

  PMID: 35943392 BACKGROUND

• Uslu 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 BACKGROUND

• Zhu 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 BACKGROUND

• Bian 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 BACKGROUND

• Kijima 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 BACKGROUND

• Yang 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 BACKGROUND

• Fu 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.

  PMID: 32418782 BACKGROUND

• Ryoo 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.

  PMID: 27353493 BACKGROUND

• Esen 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.

  PMID: 15690206 BACKGROUND

• Ying 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.

  PMID: 15121245 BACKGROUND

• Sim 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.

  PMID: 30945325 RESULT

MeSH Terms

Conditions

Disease; Neoplasms

Interventions

Ultrasonography

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Pelin Seher Oztekin, Assoc. Prof.

  Ankara Education and Research Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 28, 2022
• First Posted: July 3, 2023
• Study Start: April 1, 2021
• Primary Completion: April 1, 2022
• Study Completion: May 30, 2023
• Last Updated: July 3, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)