Breast Cancer
Conditions
Brief summary
The purpose of this study is to determine if Indocyanine Green (IC-GREEN) is comparable to isosulfan blue (IS-BLUE) in the identification of arm lymphatics and arm-draining nodes during nodal staging procedures in breast cancer.
Detailed description
It is the objective of the current study to test Indocyanine Green (IC-GREEN) as an agent for mapping arm draining lymphatics and nodes and compare it to isosulfan blue (IS-BLUE) in the setting of sentinel node procedures with or without axillary node dissections in women with breast cancer. All participants will also have tumor samples evaluated with 99technetium-sulfur colloid, a radiolabel used to identify tumor markers.
Interventions
DRUG99technetium-sulfur colloid radiolabel
DRUGIndocyanine Green
started at 1mg /mL If fluorescence is not detected with this dose, then it will be increased by 50%.
DRUGIsosulfan blue
3 to 5 mL If fluorescence is not detected with this dose, then it will be increased by 50%.
DEVICESPY Elite Imaging
A camera that is directed into the axillary cavity to try to capture an image of the tumor site labeled with Indocyanine green before and after excising sentinel nodes
Sponsors
Stanford University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* Ability to understand and the willingness to sign a written informed consent document. * Signed written informed consent. * Women undergoing sentinel lymph node biopsy. * Women with breast cancer with known or suspected lymph node involvement. * Women undergoing sentinel node identification and completion axillary lymph node dissection. * Women of 18 years of age or older. * Eastern Cooperative Oncology Group (ECOG) or Karnofsky Performance Status 0,1,2. * Complete Blood Count (CBC) and basic Metabolic Panel within 6 months
Exclusion criteria
* History of liver or kidney failure will not be eligible. * Allergies to iodine containing products will not be eligible. * Women who are pregnant will not be eligible. * Psychiatric or addictive disorders or other conditions that, in the opinion of the investigator, would preclude the patient from meeting the study requirements.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Agreement of Labeling Between Isosulfan Blue (IS-BLUE) and Indocyanine Green (IC-GREEN) | 1 day | Number of women with agreement of the two dies \[ie, isosulfan blue (IS-BLUE) and indocyanine green (IC-GREEN)\] on all nodes examined in the lymphatics and arm-draining lymph nodes, during nodal staging procedures for surgery to treat breast cancer with curative intent. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Detection of Indocyanine Green (IC-GREEN); Isosulfan Blue (IS-BLUE); and 99technetium-sulfur Colloid Radiolabel in Resected Sentinel Nodes | 1 day | The outcome is expressed as the number of participants whose resected sentinel lymph nodes (SLN) bound 99technetium-sulfur colloid (99tech), a tumor marker radiolabel; Indocyanine Green (IC-GREEN; GREEN), a fluorescent label; or isosulfan blue (IS-BLUE; BLUE), a visual dye. Results are expressed as: * Any HOT = Those whose samples bound 99tech. * Not HOT = Those whose samples did not bind 99tech. * Not HOT (also no BLUE, no GREEN) = Those whose samples did not bind 99tech; and also did not bind IC-GREEN nor IS-BLUE. * HOT, BLUE, GREEN = Those whose samples bound all of 99tech; IC-GREEN; and IS-BLUE. * HOT, no BLUE, no GREEN = Those whose samples bound 99tech, but did not bind either of IC-GREEN nor IS-BLUE. * HOT, GREEN only, no BLUE = Those whose samples bound 99tech and IC-GREEN, but did not bind IS-BLUE. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| ISB and IC-Green Dye The dose of Isosulfan blue (ISB) dye is 3 to 5 mL and Indocyanine green solution will be started at 1 mg/mL. If fluorescence is not detected with this dose, then it will be increased by 50%. A gamma probe \[Neoprobe 2010\] will be used to localize the sentinel lymph nodes in the axilla. | 23 |
| Total | 23 |
Baseline characteristics
| Characteristic | ISB and IC-Green Dye |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 3 Participants |
| Age, Categorical Between 18 and 65 years | 20 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 21 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants |
| Race (NIH/OMB) White | 20 Participants |
| Sex: Female, Male Female | 23 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 23 |
| serious Total, serious adverse events | 0 / 23 |
Outcome results
Primary
Agreement of Labeling Between Isosulfan Blue (IS-BLUE) and Indocyanine Green (IC-GREEN)
Number of women with agreement of the two dies \[ie, isosulfan blue (IS-BLUE) and indocyanine green (IC-GREEN)\] on all nodes examined in the lymphatics and arm-draining lymph nodes, during nodal staging procedures for surgery to treat breast cancer with curative intent.
Time frame: 1 day
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| ISB and IC-Green Dye | Agreement of Labeling Between Isosulfan Blue (IS-BLUE) and Indocyanine Green (IC-GREEN) | 8 Participants |
Secondary
Detection of Indocyanine Green (IC-GREEN); Isosulfan Blue (IS-BLUE); and 99technetium-sulfur Colloid Radiolabel in Resected Sentinel Nodes
The outcome is expressed as the number of participants whose resected sentinel lymph nodes (SLN) bound 99technetium-sulfur colloid (99tech), a tumor marker radiolabel; Indocyanine Green (IC-GREEN; GREEN), a fluorescent label; or isosulfan blue (IS-BLUE; BLUE), a visual dye. Results are expressed as: * Any HOT = Those whose samples bound 99tech. * Not HOT = Those whose samples did not bind 99tech. * Not HOT (also no BLUE, no GREEN) = Those whose samples did not bind 99tech; and also did not bind IC-GREEN nor IS-BLUE. * HOT, BLUE, GREEN = Those whose samples bound all of 99tech; IC-GREEN; and IS-BLUE. * HOT, no BLUE, no GREEN = Those whose samples bound 99tech, but did not bind either of IC-GREEN nor IS-BLUE. * HOT, GREEN only, no BLUE = Those whose samples bound 99tech and IC-GREEN, but did not bind IS-BLUE.
Time frame: 1 day
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ISB and IC-Green Dye | Detection of Indocyanine Green (IC-GREEN); Isosulfan Blue (IS-BLUE); and 99technetium-sulfur Colloid Radiolabel in Resected Sentinel Nodes | Any HOT | 20 participants |
| ISB and IC-Green Dye | Detection of Indocyanine Green (IC-GREEN); Isosulfan Blue (IS-BLUE); and 99technetium-sulfur Colloid Radiolabel in Resected Sentinel Nodes | Not HOT (also no BLUE, no GREEN) | 3 participants |
| ISB and IC-Green Dye | Detection of Indocyanine Green (IC-GREEN); Isosulfan Blue (IS-BLUE); and 99technetium-sulfur Colloid Radiolabel in Resected Sentinel Nodes | HOT, no BLUE, no GREEN | 12 participants |
| ISB and IC-Green Dye | Detection of Indocyanine Green (IC-GREEN); Isosulfan Blue (IS-BLUE); and 99technetium-sulfur Colloid Radiolabel in Resected Sentinel Nodes | HOT, BLUE, GREEN | 6 participants |
| ISB and IC-Green Dye | Detection of Indocyanine Green (IC-GREEN); Isosulfan Blue (IS-BLUE); and 99technetium-sulfur Colloid Radiolabel in Resected Sentinel Nodes | HOT, GREEN only, no BLUE | 2 participants |