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

Saint Petersburg State University, Russia

Status: Not yet enrolling

Conditions: Sentinel Lymph Node; Breast Neoplasms

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

Study type: Interventional

Funder types: Other

Identifiers

NCT04930692

03/21

Details and patient eligibility

About

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.

Enrollment: 31 estimated patients

Sex: Female

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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31 participants in 1 patient group

Preoperative SLNs mapping provided by CT-lymphography method

Experimental group

Description:

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.

Treatment:

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