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出境医 / 临床实验 / A Prospective Single-center Cohort Study "Preoperative Identification of Sentinel Lymph Nodes Using Contrast-enhanced CT Lymphography in Breast Cancer Patients"

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

Study Description
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.

Condition or disease Intervention/treatment Phase
Breast Neoplasms Sentinel Lymph Node Diagnostic Test: Contrast-enhanced CT lymphography with the periareolar injection of iopamidol Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 31 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: A Prospective Single-center Cohort Study "Preoperative Identification of Sentinel Lymph Nodes Using Contrast-enhanced CT Lymphography in Breast Cancer Patients"
Estimated Study Start Date : September 1, 2021
Estimated Primary Completion Date : February 1, 2022
Estimated Study Completion Date : July 1, 2022
Arms and Interventions
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.
 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.
Outcome Measures
Primary Outcome Measures :
  1. 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.

  2. Preoperative detection of sentinel lymph nodes metastases [ Time Frame: 8 months ]
    Second primary endpoint is to assess the capabilities of contrast-enhanced CT lymphography for detecting metastases in sentinel lymph nodes in breast cancer patients


Secondary Outcome Measures :
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
Contacts and Locations

Contacts
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Contact: Valeria Konstantinova, MD +79315352637 konstantinova.valery@gmail.com

Locations
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Russian Federation
Saint-Petersburg State University Hospital
Saint Petersburg, Russian Federation, 190103
Contact    +7(812)676-25-25    6762525@gosmed.ru   
Sponsors and Collaborators
Saint Petersburg State University, Russia
Investigators
Layout table for investigator information
Principal Investigator: Ruslan Ahmedov, MD Saint-Petersburg State University Hospital
Tracking Information
First Submitted Date  ICMJE June 10, 2021
First Posted Date  ICMJE June 18, 2021
Last Update Posted Date June 18, 2021
Estimated Study Start Date  ICMJE September 1, 2021
Estimated Primary Completion Date February 1, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 11, 2021)
  • 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.
  • Preoperative detection of sentinel lymph nodes metastases [ Time Frame: 8 months ]
    Second primary endpoint is to assess the capabilities of contrast-enhanced CT lymphography for detecting metastases in sentinel lymph nodes in breast cancer patients
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: June 11, 2021) 		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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Prospective Single-center Cohort Study "Preoperative Identification of Sentinel Lymph Nodes Using Contrast-enhanced CT Lymphography in Breast Cancer Patients"
Official Title  ICMJE A Prospective Single-center Cohort Study "Preoperative Identification of Sentinel Lymph Nodes Using Contrast-enhanced CT Lymphography in Breast Cancer Patients"
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE
  • Breast Neoplasms
  • Sentinel Lymph Node
Intervention  ICMJE 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.
Study Arms  ICMJE 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.
Intervention: Diagnostic Test: Contrast-enhanced CT lymphography with the periareolar injection of iopamidol
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: June 11, 2021) 		31
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 1, 2022
Estimated Primary Completion Date February 1, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Valeria Konstantinova, MD +79315352637 konstantinova.valery@gmail.com
Listed Location Countries  ICMJE Russian Federation
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04930692
Other Study ID Numbers  ICMJE 03/21
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Ruslan Ahmedov, Saint Petersburg State University, Russia
Study Sponsor  ICMJE Saint Petersburg State University, Russia
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Ruslan Ahmedov, MD Saint-Petersburg State University Hospital
PRS Account Saint Petersburg State University, Russia
Verification Date June 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP