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

Breast Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04930692
• Other study ID #: 03/21
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 1, 2022
• Est. completion date: August 1, 2023

Study information

• Verified date: September 2022
• Source: Saint Petersburg State University, Russia
• Contact: Valeria Konstantinova, MD
• Phone: +79315352637
• Email: konstantinova.valery[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 31
• Est. completion date: August 1, 2023
• Est. primary completion date: March 1, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Breast Neoplasms
• Sentinel Lymph Node

Intervention

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.

Locations

Country	Name	City	State
Russian Federation	Saint-Petersburg State University Hospital	Saint Petersburg

Sponsors (1)

Lead Sponsor	Collaborator
Saint Petersburg State University, Russia

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensitivity and specificity of contrast-enhanced CT lymphography	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.	8 months
Primary	Preoperative detection of sentinel lymph nodes metastases	Second primary endpoint is to assess the capabilities of contrast-enhanced CT lymphography for detecting metastases in sentinel lymph nodes in breast cancer patients	8 months
Secondary	Objective criteria for metastatic lesions of sentinel lymph nodes	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.	8 months