Comparison of Use of Indocyanine Green and 99mTc-labeled Radiotracer for Axillary Lymphatic Mapping in Patients With Breast Cancer

NCT ID: NCT02419807

Last Updated: 2022-06-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 102 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-02-17
• Study Completion Date: 2019-02-28

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.

Conditions

Stage I Breast Cancer; Stage II Breast Cancer

Study Design

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

Study Groups

Diagnostic (indocyanine green, 99mTc-labeled radiotracer)

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.

Group Type: EXPERIMENTAL

Indocyanine Green Solution

Intervention Type: DRUG

Given subdermally

Technetium Tc-99m Sulfur Colloid

Intervention Type: RADIATION

Given via injection

Lymphoscintigraphy

Intervention Type: PROCEDURE

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.

Axillary Lymph Node Biopsy

Intervention Type: PROCEDURE

Undergo biopsy

Interventions

Indocyanine Green Solution

Given subdermally

Intervention Type: DRUG

Technetium Tc-99m Sulfur Colloid

Given via injection

Intervention Type: RADIATION

Lymphoscintigraphy

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

Axillary Lymph Node Biopsy

Undergo biopsy

Intervention Type: PROCEDURE

Other Intervention Names

IC-GREEN; ICG solution; Tc 99m Sulfur Colloid; Tc-99m SC; Technetium Tc 99m Sulfur Colloid; Undergo lymphoscintigraphy; Axillary Node Biopsy; axillary sentinel lymph node biopsy

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

• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Mitaka USA, Inc.

INDUSTRY

Sponsor Role: collaborator

Case Comprehensive Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Stephen Grobmyer, MD

Role: PRINCIPAL_INVESTIGATOR

Case Comprehensive Cancer Center

Locations

Cleveland Clinic Taussig Cancer Instititute, Case Comprehensive Cancer Center

Cleveland, Ohio, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

CASE10114

Identifier Type: -

Identifier Source: org_study_id