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

NCT02419807 | Completed Results DMC FDA Device

• 1 other identifier: CASE10114
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline

Study Arms (1)

Diagnostic (indocyanine green, 99mTc-labeled radiotracer)

EXPERIMENTAL

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.

Drug: Indocyanine Green Solution; Radiation: Technetium Tc-99m Sulfur Colloid; Procedure: Lymphoscintigraphy; Procedure: Axillary Lymph Node Biopsy

Interventions

Indocyanine Green Solution DRUG

Given subdermally

Also known as: IC-GREEN, ICG solution

Diagnostic (indocyanine green, 99mTc-labeled radiotracer)

Technetium Tc-99m Sulfur Colloid RADIATION

Given via injection

Also known as: Tc 99m Sulfur Colloid, Tc-99m SC, Technetium Tc 99m Sulfur Colloid

Diagnostic (indocyanine green, 99mTc-labeled radiotracer)

Lymphoscintigraphy 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.

Also known as: Undergo lymphoscintigraphy

Diagnostic (indocyanine green, 99mTc-labeled radiotracer)

Axillary Lymph Node Biopsy PROCEDURE

Undergo biopsy

Also known as: Axillary Node Biopsy, axillary sentinel lymph node biopsy

Diagnostic (indocyanine green, 99mTc-labeled radiotracer)

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Case Comprehensive Cancer Center: lead
• National Cancer Institute (NCI): collaborator
• Mitaka USA, Inc.: collaborator

Study Sites (1)

Cleveland Clinic Taussig Cancer Instititute, Case Comprehensive Cancer Center

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Indocyanine Green; Technetium Tc 99m Sulfur Colloid

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Sulfur Compounds; Inorganic Chemicals; Technetium Compounds

Results Point of Contact

• Title: Dr. Stephen Grobmyer
• Organization: Cleveland Clinic, Case Comprehensive Cancer Center

TaussigResearch@ccf.org

1-866-223-8100

Study Officials

• Stephen Grobmyer, MD

  Case Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2015
• First Posted: April 17, 2015
• Study Start: February 17, 2015
• Primary Completion: February 1, 2019
• Study Completion: February 1, 2019
• Last Updated: June 30, 2022
• Results First Posted: October 22, 2020

Record last verified: 2022-06

Locations

US (1)