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

NCT04930692 | Unknown

• 1 other identifier: 03/21
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Neoplasms; Sentinel Lymph Node

Keywords

Breast cancer; Sentinel lymph nodes; CT-Lymphography

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (1)

• Objective criteria for metastatic lesions of sentinel lymph nodes

  8 months

Study Arms (1)

Preoperative SLNs mapping provided by CT-lymphography method

EXPERIMENTAL

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.

Diagnostic Test: Contrast-enhanced CT lymphography with the periareolar injection of iopamidol

Interventions

Contrast-enhanced CT lymphography with the periareolar injection of iopamidol DIAGNOSTIC_TEST

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.

Preoperative SLNs mapping provided by CT-lymphography method

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \> 18 years;
• Signed informed consent;
• Histologically confirmed breast cancer

You may not qualify if:

• 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.

Sponsors & Collaborators

• Saint Petersburg State University, Russia: lead

Study Sites (1)

Saint-Petersburg State University Hospital

Saint Petersburg, 190103, Russia

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Ruslan Ahmedov, MD

  Saint Petersburg State University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Valeria Konstantinova, MD

CONTACT

+79315352637; konstantinova.valery@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: June 10, 2021
• First Posted: June 18, 2021
• Study Start: October 1, 2022
• Primary Completion: March 1, 2023
• Study Completion: August 1, 2023
• Last Updated: September 6, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)