- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04930692
A Prospective Single-center Cohort Study "Preoperative Identification of Sentinel Lymph Nodes Using Contrast-enhanced CT Lymphography in Breast Cancer Patients"
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Valeria Konstantinova, MD
- Phone Number: +79315352637
- Email: konstantinova.valery@gmail.com
Study Locations
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-
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Saint Petersburg, Russian Federation, 190103
- Saint-Petersburg State University Hospital
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Contact:
- Phone Number: +7(812)676-25-25
- Email: 6762525@gosmed.ru
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
|
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Sensitivity and specificity of contrast-enhanced CT lymphography
Time Frame: 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.
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8 months
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Preoperative detection of sentinel lymph nodes metastases
Time Frame: 8 months
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Second primary endpoint is to assess the capabilities of contrast-enhanced CT lymphography for detecting metastases in sentinel lymph nodes in breast cancer patients
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8 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Objective criteria for metastatic lesions of sentinel lymph nodes
Time Frame: 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.
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8 months
|
Collaborators and Investigators
Investigators
- Principal Investigator: Ruslan Ahmedov, MD, Saint-Petersburg State University Hospital
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 03/21
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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