A Prospective Single-center Cohort Study “Preoperative Identification of Sentinel Lymph Nodes Using Contrast-enhanced CT Lymphography in Breast Cancer Patients”

Overview

The main hypothesis of this study is that contrast-enhanced CT lymphography can be used for preoperative visualization of sentinel lymph nodes in breast cancer patients. We assume that CT lymphography is a high-sensitivity and high-specificity method for sentinel lymph nodes' mapping in breast cancer patients. We also assume that positive predictive value and negative predictive value for identification of presence or absence of metastases in sentinel lymph nodes (SLN) will be high enough for preoperative diagnosis of SLN metastases in breast cancer patients. This study will use CT lymphography with periareolar injection of iopamidol and standard protocols of sentinel lymph nodes biopsy using intraoperative indocyanine green (ICG) fluorescence.

Full Title of Study: “A Prospective Single-center Cohort Study “Preoperative Identification of Sentinel Lymph Nodes Using Contrast-enhanced CT Lymphography in Breast Cancer Patients””

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Diagnostic
    • Masking: None (Open Label)
  • Study Primary Completion Date: February 1, 2022

Interventions

  • Diagnostic Test: Contrast-enhanced CT lymphography with the periareolar injection of iopamidol
    • Patients who meet the inclusion/exclusion criteria will undergo the CT lymphography with periaoreolar injection of a mixture of 4 mL iopamidol and 2 mL of 1% lidocaine hydrochloride. Computed tomographic images will be obtained 1, 3, 5, and 10 minutes after administration of the iopamidol. Following enhancement of the lymphatic duct, the first lymph node to show enhancement will be defined as the SLN. No later than 10 days after the CT lymphography patients will receive surgical treatment. During breast cancer surgery identification of the SLN using the ICG-fluorescence method with injection of 2 ml indocyanine green into the skin of the areola and the biopsy of identified SLN will be performed. The comparison of the results of CT lymphography and SLN biopsy will be administrated by the investigator.

Arms, Groups and Cohorts

  • Experimental: Preoperative SLNs mapping provided by CT-lymphography method
    • Sentinel lymph nodes will be mapped by contrast-enhanced CT lymphography in breast cancer patients. A mixture of 4 mL iopamidol and 2 mL of 1% lidocaine hydrochloride will be used as a contrast agent provided by periaoreolar injection. No later than 10 days after the CT lymphography patients will receive surgical treatment with sentinel lymph node biopsy using the ICG-fluorescence method.

Clinical Trial Outcome Measures

Primary Measures

  • Sensitivity and specificity of contrast-enhanced CT lymphography
    • Time Frame: 8 months
    • First primary endpoint is to determine the sensitivity and specificity of contrast-enhanced CT lymphography for the preoperative detection of sentinel lymph nodes in breast cancer in comparison with the intraoperative fluorescence method.
  • Preoperative detection of sentinel lymph nodes metastases
    • Time Frame: 8 months
    • Second primary endpoint is to assess the capabilities of contrast-enhanced CT lymphography for detecting metastases in sentinel lymph nodes in breast cancer patients

Secondary Measures

  • Objective criteria for metastatic lesions of sentinel lymph nodes
    • Time Frame: 8 months
    • Secondary endpoint is to identify objective criteria for metastatic lesions of sentinel lymph nodes (SLN), such as 1) the shape of the lymphatic duct; 2) the contrast enhancement of the SLN (full or heterogeneous); 3) the size of the SLN; 4) the form of the SLN; 5) the density of the SLN.

Participating in This Clinical Trial

Inclusion Criteria

  • Age > 18 years; – Signed informed consent; – Histologically confirmed breast cancer Exclusion Criteria:

  • Iodine allergy; – Presence of distant metastases of breast cancer; – Body mass index more than 40; – Chronic cardiovascular and cerebrovascular diseases in the stage of decompensation or recent acute conditions (myocardial infarction, brain stroke, etc.) – Suspected pregnancy; – Severe hypothyroidism; – Bronchial asthma in the stage of decompensation; – Decompensated diabetes; – Kidney or hepatic failure.

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Saint Petersburg State University, Russia
  • Provider of Information About this Clinical Study
    • Principal Investigator: Ruslan Ahmedov, MD – Saint Petersburg State University, Russia
  • Overall Official(s)
    • Ruslan Ahmedov, MD, Principal Investigator, Saint-Petersburg State University Hospital
  • Overall Contact(s)
    • Valeria Konstantinova, MD, +79315352637, konstantinova.valery@gmail.com

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