Stage I Breast Cancer, Stage II Breast Cancer
Conditions
Keywords
Near Infrared Fluorescence Imaging, Indocyanine Green, axillary lymph node mapping, Mastectomy, Segmental, Sentinel Lymph Node Biopsy, Lumpectomy
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.
Interventions
Given subdermally
RADIATIONTechnetium Tc-99m Sulfur Colloid
Given via injection
PROCEDURELymphoscintigraphy
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.
PROCEDUREAxillary Lymph Node Biopsy
Undergo biopsy
Sponsors
National Cancer Institute (NCI)
Mitaka USA, Inc.
Case Comprehensive Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 102 |
| Total | 102 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Physician Decision | 1 |
| Overall Study | Protocol Violation | 5 |
| Overall Study | Withdrawal by Subject | 4 |
Baseline characteristics
| Characteristic | Diagnostic (Indocyanine Green, 99mTc-labeled Radiotracer) |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 36 Participants |
| Age, Categorical Between 18 and 65 years | 66 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 96 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants |
| Race (NIH/OMB) Asian | 2 Participants |
| Race (NIH/OMB) Black or African American | 8 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 90 Participants |
| Region of Enrollment United States | 102 participants |
| Sex: Female, Male Female | 102 Participants |
| Sex: Female, Male Male | 0 Participants |
| Tc-negative and ICG-positive SNs | 33 sentinel nodes |
| Tc-positive and ICG-negative sentinel nodes (SNs) | 11 sentinel nodes |
| Tc-positive and ICG-positive sentinel nodes (SNs) | 191 sentinel nodes |
| Total sentinel lymph nodes (SLNs) | 235 sentinel nodes |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 102 |
| other Total, other adverse events | 0 / 102 |
| serious Total, serious adverse events | 0 / 102 |
Outcome results
Primary
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.
Time frame: Baseline
Population: Participants who completed study
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Diagnostic (Indocyanine Green, 99mTc-labeled Radiotracer) | Proportion of Sentinel Lymph Nodes (SLNs) Flagged by the Two Methods | Proportion of SNs (PTc) detected by Tc method | 0.86 proportion of nodes |
| Diagnostic (Indocyanine Green, 99mTc-labeled Radiotracer) | Proportion of Sentinel Lymph Nodes (SLNs) Flagged by the Two Methods | Proportion of SNs (PICG) detected by ICG method | 0.95 proportion of nodes |
95% CI: [0.036, 0.151]