Comparison of Use of Indocyanine Green and 99mTc-labeled Radiotracer for Axillary Lymphatic Mapping in Patients With Breast Cancer
Primary Purpose
Stage I Breast Cancer, Stage II Breast Cancer
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Indocyanine Green Solution
Technetium Tc-99m Sulfur Colloid
Lymphoscintigraphy
Axillary Lymph Node Biopsy
Sponsored by
About this trial
This is an interventional diagnostic trial for Stage I Breast Cancer focused on measuring Near Infrared Fluorescence Imaging, Indocyanine Green, axillary lymph node mapping, Mastectomy, Segmental, Sentinel Lymph Node Biopsy, Lumpectomy
Eligibility Criteria
Inclusion Criteria:
- Participants with a confirmed diagnosis of clinical stage 1 or 2 breast cancer
- Participants who are undergoing breast cancer surgery with lumpectomy or mastectomy
- Participants with planned axillary sentinel node biopsy procedure
Exclusion Criteria:
- Participants with cancer > 3 cm
- Participants with clinically positive nodes
- Participants with prior surgery for breast cancer in the index breast
- Participants who have had bilateral breast surgeries
- Thyroid dysfunction
- Hypersensitivity to iodine
- Hepatic insufficiency
- Renal insufficiency
Sites / Locations
- Cleveland Clinic Taussig Cancer Instititute, Case Comprehensive Cancer Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Diagnostic (indocyanine green, 99mTc-labeled radiotracer)
Arm Description
Participants receive technetium Tc-99m sulfur colloid injection and undergo lymphoscintigraphy according to clinical practice. Prior to surgery, participants also receive indocyanine green solution subdermally close to the tumor or into subareolar region of the breast skin. Participants then undergo Axillary Lymph Node Biopsy and surgery.
Outcomes
Primary Outcome Measures
Proportion of Sentinel Lymph Nodes (SLNs) Flagged by the Two Methods
Let A be the number of Tc-positive and ICG-positive sentinel nodes (SNs) detected, B be the number of Tc-positive and ICG-negative SNs detected, and C be the number of Tc-negative and ICG-positive SNs detected. The total number (N) of SNs detected is therefore N = (A + B + C); the proportion of SNs detected by the Tc method (PTc) is (A + B)/N; and the proportion of SNs detected by the ICG method (PICG) is (A + C)/N. Differences in the proportions of SLNs flagged will be compared using a two-sided 95% confidence interval.
Secondary Outcome Measures
Full Information
NCT ID
NCT02419807
First Posted
April 14, 2015
Last Updated
June 29, 2022
Sponsor
Case Comprehensive Cancer Center
Collaborators
National Cancer Institute (NCI), Mitaka USA, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT02419807
Brief Title
Comparison of Use of Indocyanine Green and 99mTc-labeled Radiotracer for Axillary Lymphatic Mapping in Patients With Breast Cancer
Official Title
Comparison of Use of Indocyanine Green and 99mTc-labeled Radiotracer for Axillary Lymphatic Mapping in Patients With Breast Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
February 17, 2015 (Actual)
Primary Completion Date
February 2019 (Actual)
Study Completion Date
February 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Case Comprehensive Cancer Center
Collaborators
National Cancer Institute (NCI), Mitaka USA, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This clinical trial will enroll up to 130 adult women with a confirmed diagnosis of clinical stage 1 or 2 breast cancer who are undergoing breast cancer surgery with lumpectomy or mastectomy and planned axillary sentinel node biopsy procedure. Participants will undergo lymphatic mapping with technetium Tc-99m (99mTc) sulfur colloid in accordance with routine clinical practice. Injections of 99mTc sulfur colloid will take place the afternoon prior to planned next morning surgery or on the morning of surgery. Participants will undergo lymphoscintigraphy in accordance with standard clinical practice.
Immediately prior to operation, after the induction of anesthesia in the operating room, up to 1cc of 0.5% indocyanine green (ICG) solution will be injected subdermally close to the tumor or into the subareolar region after disinfection of the breast skin. ICG movement will be facilitated by manual massage and monitored with fluorescence imaging. ICG fluorescence will be elicited and detected by Photodynamic Eye (PDE) camera. The lymphatic drainage, made evident by the fluorescent dye, will be monitored in real time on a monitor. The fluorescence will be followed towards the armpit region (axilla) and time for the fluorescence to reach the axilla will be recorded. Following standard practice, an incision will be made in the armpit region. Fluorescent lymph nodes (ICG positive) will be localized and removed and analyzed by a pathologist. Node removal will continue until no residual fluorescence is visible in the axilla. Removed nodes will be tested for radioactivity using a standard gamma-detecting probe and the counts per minute will be recorded. Finally, the armpit region will be inspected with the gamma probe to determine if there are any residual radioactive nodes. Residual sentinel nodes (the first node to receive lymph from a tumor) will be removed. For the purposes of this study, the sentinel status of a node will be defined as being flagged as sentinel by either one or both of the ICG or 99mTc methods. The goal of the project is to confirm that axillary lymphatic mapping with ICG leads to similar nodes being labeled as sentinel as lymphatic mapping with 99mTc-labeled radiotracer.
Detailed Description
PRIMARY OBJECTIVES:
I. To confirm that axillary lymphatic mapping with indocyanine green solution (ICG) solution leads to a similar number of nodes being labeled as sentinel as lymphatic mapping with 99mTc-labeled (technetium Tc-99m sulfur colloid) radiotracer.
OUTLINE:
Participants receive technetium Tc-99m sulfur colloid injection and undergo lymphoscintigraphy according to clinical practice. Prior to surgery, participants also receive indocyanine green solution subdermally close to the tumor or into subareolar region of the breast skin. Participants then undergo axillary sentinel node biopsy and surgery.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stage I Breast Cancer, Stage II Breast Cancer
Keywords
Near Infrared Fluorescence Imaging, Indocyanine Green, axillary lymph node mapping, Mastectomy, Segmental, Sentinel Lymph Node Biopsy, Lumpectomy
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
102 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Diagnostic (indocyanine green, 99mTc-labeled radiotracer)
Arm Type
Experimental
Arm Description
Participants receive technetium Tc-99m sulfur colloid injection and undergo lymphoscintigraphy according to clinical practice. Prior to surgery, participants also receive indocyanine green solution subdermally close to the tumor or into subareolar region of the breast skin. Participants then undergo Axillary Lymph Node Biopsy and surgery.
Intervention Type
Drug
Intervention Name(s)
Indocyanine Green Solution
Other Intervention Name(s)
IC-GREEN, ICG solution
Intervention Description
Given subdermally
Intervention Type
Radiation
Intervention Name(s)
Technetium Tc-99m Sulfur Colloid
Other Intervention Name(s)
Tc 99m Sulfur Colloid, Tc-99m SC, Technetium Tc 99m Sulfur Colloid
Intervention Description
Given via injection
Intervention Type
Procedure
Intervention Name(s)
Lymphoscintigraphy
Other Intervention Name(s)
Undergo lymphoscintigraphy
Intervention Description
This is a method used to check the lymph system for disease. A radioactive substance that flows through the lymph ducts and can be taken up by lymph nodes is injected into the body. A scanner or probe is used to follow the movement of this substance on a computer screen. Lymphoscintigraphy is used to find the sentinel lymph node (the first node to receive lymph from a tumor), which may be removed and checked for tumor cells. Lymphoscintigraphy is also used to diagnose certain diseases or conditions, such as lymphoma or lymphedema.
Intervention Type
Procedure
Intervention Name(s)
Axillary Lymph Node Biopsy
Other Intervention Name(s)
Axillary Node Biopsy, axillary sentinel lymph node biopsy
Intervention Description
Undergo biopsy
Primary Outcome Measure Information:
Title
Proportion of Sentinel Lymph Nodes (SLNs) Flagged by the Two Methods
Description
Let A be the number of Tc-positive and ICG-positive sentinel nodes (SNs) detected, B be the number of Tc-positive and ICG-negative SNs detected, and C be the number of Tc-negative and ICG-positive SNs detected. The total number (N) of SNs detected is therefore N = (A + B + C); the proportion of SNs detected by the Tc method (PTc) is (A + B)/N; and the proportion of SNs detected by the ICG method (PICG) is (A + C)/N. Differences in the proportions of SLNs flagged will be compared using a two-sided 95% confidence interval.
Time Frame
Baseline
10. Eligibility
Sex
Female
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Participants with a confirmed diagnosis of clinical stage 1 or 2 breast cancer
Participants who are undergoing breast cancer surgery with lumpectomy or mastectomy
Participants with planned axillary sentinel node biopsy procedure
Exclusion Criteria:
Participants with cancer > 3 cm
Participants with clinically positive nodes
Participants with prior surgery for breast cancer in the index breast
Participants who have had bilateral breast surgeries
Thyroid dysfunction
Hypersensitivity to iodine
Hepatic insufficiency
Renal insufficiency
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephen Grobmyer, MD
Organizational Affiliation
Case Comprehensive Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cleveland Clinic Taussig Cancer Instititute, Case Comprehensive Cancer Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Comparison of Use of Indocyanine Green and 99mTc-labeled Radiotracer for Axillary Lymphatic Mapping in Patients With Breast Cancer
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