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

NCT02419807 — Not applicable, Completed, 102 participants, Case Comprehensive Cancer Center

ClinicalTrials Daily · Areas · Conditions · Drugs · Sponsors ·

Registry	NCT02419807
Status	Completed
Phase	Not applicable
Study type	Interventional; na, single group, masking: none, diagnostic
Enrollment	102 (Actual)
Sponsor	Case Comprehensive Cancer Center (Other); collaborators: National Cancer Institute (NCI), Mitaka USA, Inc.
Conditions	Stage I Breast Cancer, Stage II Breast Cancer
Interventions	Indocyanine Green Solution, Technetium Tc-99m Sulfur Colloid, Lymphoscintigraphy, Axillary Lymph Node Biopsy (Drug, radiation, procedure)
Dates	start 2015-02-17, primary completion 2019-02-01, completion 2019-02-01, first posted 2015-04-17, last updated 2022-06-30
Locations	1 site in United States

-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.

Expand all sections · Collapse all

+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.

+Arms and interventions

Arm	Type	Interventions	Description
Diagnostic (indocyanine green, 99mTc-labeled radiotracer)	Experimental	Drug: Indocyanine Green Solution; Radiation: Technetium Tc-99m Sulfur Colloid; Procedure: Lymphoscintigraphy; Procedure: Axillary Lymph Node Biopsy	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.

Indocyanine Green Solution (Drug), also known as IC-GREEN, ICG solution: Given subdermally
Technetium Tc-99m Sulfur Colloid (Radiation), also known as Tc 99m Sulfur Colloid, Tc-99m SC, Technetium Tc 99m Sulfur Colloid: Given via injection
Lymphoscintigraphy (Procedure), also known as Undergo 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.
Axillary Lymph Node Biopsy (Procedure), also known as Axillary Node Biopsy, axillary sentinel lymph node biopsy: Undergo biopsy

+Outcome measures

Primary outcomes

Proportion of Sentinel Lymph Nodes (SLNs) Flagged by the Two Methods [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 (PICG) is (A + C)/N. Differences in the proportions of SLNs flagged will be compared using a two-sided 95% confidence interval.

+Eligibility

Sex: Female

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

+Posted results

Participant flow

Milestone	Diagnostic (Indocyanine Green, 99mTc-labeled Radiotracer)
Started	102
Completed	92
Not completed	10

Outcome results

Proportion of Sentinel Lymph Nodes (SLNs) Flagged by the Two Methods (Primary), Number, proportion of nodes: Diagnostic (Indocyanine Green, 99mTc-labeled Radiotracer) 0.86

Adverse events

Time frame: Participants were monitored for adverse events for 30 days following their surgical operation

Arm	Deaths	Serious adverse events	Other adverse events
Diagnostic (Indocyanine Green, 99mTc-labeled Radiotracer)	0/102 (0.0%)	0/102 (0.0%)	0/102 (0.0%)

+Locations (1)

Facility	City	Country	Status
Cleveland Clinic Taussig Cancer Instititute, Case Comprehensive Cancer Center	Cleveland, Ohio	United States

+Study documents

Study Protocol and Statistical Analysis Plan (PDF, 2016-11-18)
Informed Consent Form (PDF, 2018-02-13)

+Investigators

Stephen Grobmyer, MD, Principal investigator, Case Comprehensive Cancer Center