NCT02419807

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

Completed NA Results posted Last updated 29 June 2022

What this trial tests

NA trial testing Indocyanine Green Solution in Stage I Breast Cancer in 102 participants. Completed in 1 February 2019.

Timeline

17 February 2015

Primary endpoint
1 February 2019

1 February 2019

Quick facts

Lead sponsor	Case Comprehensive Cancer Center
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	diagnostic
Enrollment	102
Start date	17 February 2015
Primary completion	1 February 2019
Estimated completion	1 February 2019
Sites	1 location across United States

Drugs / interventions tested

• Indocyanine Green Solution — full drug profile →
• Technetium Tc-99m Sulfur Colloid
• Lymphoscintigraphy
• Axillary Lymph Node Biopsy

Conditions studied

• Stage I Breast Cancer — all drugs for Stage I Breast Cancer →
• Stage II Breast Cancer — all drugs for Stage II Breast Cancer →

Sponsor

Case Comprehensive Cancer Center — full company profile →

Who can join

Eligibility, female only, with Stage I Breast Cancer or Stage II Breast Cancer. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Proportion of Sentinel Lymph Nodes (SLNs) Flagged by the Two Methods
  Time frame: Baseline
  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 (

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Fluorescence Guidance in Surgical Oncology: Challenges, Opportunities, and Translation.
   Olson MT, Ly QP, Mohs AM. · · 2019 · cited 48× · PMID 29942988 · DOI 10.1007/s11307-018-1239-2
2. Recent Advancements of Nanomedicine in Breast Cancer Surgery.
   Meng X, Wang X, Zhang Z, Song L, et al · · 2024 · cited 5× · PMID 39759962 · DOI 10.2147/ijn.s494364