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

NCT ID: NCT04930692

Last Updated: 2022-09-06

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 31 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-01
• Study Completion Date: 2023-08-01

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Contrast-enhanced CT lymphography with the periareolar injection of iopamidol

Intervention Type: 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.

Interventions

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.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Saint Petersburg State University, Russia

OTHER

Sponsor Role: lead

Responsible Party

Ruslan Ahmedov

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ruslan Ahmedov, MD

Role: PRINCIPAL_INVESTIGATOR

Saint Petersburg State University Hospital

Locations

Saint-Petersburg State University Hospital

Saint Petersburg, , Russia

Countries

Russia

Central Contacts

Valeria Konstantinova, MD

Role: CONTACT

konstantinova.valery@gmail.com

+79315352637

Facility Contacts

Role: primary

6762525@gosmed.ru

+7(812)676-25-25

Other Identifiers

03/21

Identifier Type: -

Identifier Source: org_study_id