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

Not Applicable

Not yet recruiting

• Conditions: Sentinel Lymph Node; Breast Neoplasms
• Interventions: Diagnostic Test: Contrast-enhanced CT lymphography with the periareolar injection of iopamidol

• Registration Number: NCT04930692
• Lead Sponsor: Saint Petersburg State University, Russia

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-06-10
• Study First Submitted QC: 2021-06-11
• Study First Posted: 2021-06-18
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-02
• Last Update Posted: 2022-09-06
• Study Start: 2022-10-01
• Primary Completion: 2023-03-01
• Study Completion: 2023-08-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 31

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Preoperative SLNs mapping provided by CT-lymphography method	Contrast-enhanced CT lymphography with the periareolar injection of iopamidol	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.

Primary Outcome Measures

Name	Time	Method
Sensitivity and specificity of contrast-enhanced CT lymphography	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	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 Outcome Measures

Name	Time	Method
Objective criteria for metastatic lesions of sentinel lymph nodes	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.

Trial Locations

Locations (1)

Saint-Petersburg State University Hospital; 🇷🇺 Saint Petersburg, Russian Federation