Breast Cancer, Melanoma (Skin), Sentinel Lymph Node
Conditions
Brief summary
The objective of this study is to determine if fluorescence lymphangiography can be used alone to localize sentinel nodes in patients with melanoma or breast cancer. The hypothesis is that sentinel nodes can be identified using only indocyanine green (ICG) and fluorescence lymphangiography, without the need for technetium99 and a gamma probe.
Detailed description
From the subject's viewpoint, the course of events in this study will be no different than usual care and sentinel node biopsy. Subjects will have a dermal injection of technetium99 (tech99) at the melanoma tumor site prior to surgery (either the day before, or morning of surgery) or a subareolar injection if breast cancer. The surgeon will not look at the lymphoscintigraphy films, and the radiologist should not mark the skin. When the subject is in the operating room and appropriately sedated or anesthetized, tthey will receive a dermal injection of indocyanine green (ICG) 0.3-1.0 ml at the melanoma tumor site or subareola if breast cancer. Incision is made in the axilla or groin, and the SPY machine is positioned over the lymph node basin. Real-time lymphangiography (SPY) is used to identify sentinel nodes. Any fluorescent nodes should be resected and are considered sentinel nodes. The absolute fluorescence will be quantified for each sentinel node. Absolute fluorescence is calculated by the SPY machine. After the sentinel lymphadenectomy is complete but prior to closing skin, the excised lymph nodes will be examined with the gamma probe (detects tech99 signal) to confirm that they are sentinel nodes. If the node does not have a signal with the gamma probe (but is fluorescent) it is still considered a sentinel node. The lymph node basin will also be examined with the gamma probe, to insure that no sentinel nodes are missed. If a gamma positive sentinel node is identified in the lymph node basin, it should be resected and imaged with SPY. If no sentinel nodes are able to be identified with fluorescent imaging, the gamma probe will be used as per usual practice. The surgeon should spend no more than 30 minutes using SPY to identify sentinel nodes. If after 30 minutes no sentinel node is found, the gamma probe should be used. The data collection form should be completed for each case. The investigators intend to enroll at least 48 subjects. In order to insure that the data collected accurately represents the effectiveness of the SPY machine, each surgeon will be required to enroll at least 8 subjects into the study. Sentinel node biopsy is a routine surgical procedure, and all involved PIs are experienced in performing sentinel node biopsy. While fluorescence imaging intra-op is novel, the actual procedure itself is no different.
Interventions
DRUGIC-Green KIT
fluorescence lymphangiography with the use of IC-Green
Sponsors
Vassar Brothers Medical Center
Emory University
Milton S. Hershey Medical Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients with melanoma or breast cancer who meet criteria for and consent to sentinel node biopsy.The melanoma should be located on the upper extremity between and including the wrist and shoulder, or the lower extremity between and including the ankle and groin.
Exclusion criteria
* Melanoma located on the trunk, head or neck. Patients with an allergy to indocyanine green or sodium iodide. Pregnant and nursing women. Patients who have had a prior sentinel node biopsy in the same nodal basin.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Where the First, Second and Third Sentinel Nodes Localized With the Use of Fluorescence Imaging Alone | Intraoperative, up to 1 hour | The number of participants who had their first, second and third sentinel nodes correctly identified with ICG and fluorescence imaging alone, without the use of technetium99 and gamma probe. The number of sentinel nodes in any participant is determined by the patient's anatomy. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Events | Four weeks | Any adverse events related to ICG or sentinel node biopsy. |
Countries
United States
Participant flow
Recruitment details
Subjects recruited in surgical clinic between 10/11/2017 - 9/13/2021
Pre-assignment details
One subject withdrew due to change in OR location and lack of SPY machine. No other relevant events.
Participants by arm
| Arm | Count |
|---|---|
| Patients With Melanoma or Breast Cancer The SPY machine used in conjunction with the IC-green kit will be used exclusively to identify sentinel nodes in patients diagnosed with Melanoma or Breast Cancer who are undergoing sentinel lymph node biopsy.
IC-Green KIT: fluorescence lymphangiography with the use of IC-Green | 35 |
| Total | 35 |
Baseline characteristics
| Characteristic | Patients With Melanoma or Breast Cancer |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 18 Participants |
| Age, Categorical Between 18 and 65 years | 17 Participants |
| Age, Continuous | 64.5 years |
| BMI | 27.3 kg/m^2 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 35 Participants |
| Region of Enrollment United States | 35 participants |
| Sex: Female, Male Female | 18 Participants |
| Sex: Female, Male Male | 17 Participants |
| Tumor location Lower extremity | 14 Participants |
| Tumor location Upper extremity | 21 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 35 |
| other Total, other adverse events | 7 / 35 |
| serious Total, serious adverse events | 0 / 35 |
Outcome results
Primary
Number of Participants Where the First, Second and Third Sentinel Nodes Localized With the Use of Fluorescence Imaging Alone
The number of participants who had their first, second and third sentinel nodes correctly identified with ICG and fluorescence imaging alone, without the use of technetium99 and gamma probe. The number of sentinel nodes in any participant is determined by the patient's anatomy.
Time frame: Intraoperative, up to 1 hour
Population: Patients with cutaneous melanoma of the extremity.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Patients With Melanoma or Breast Cancer | Number of Participants Where the First, Second and Third Sentinel Nodes Localized With the Use of Fluorescence Imaging Alone | First sentinel node | 29 Participants |
| Patients With Melanoma or Breast Cancer | Number of Participants Where the First, Second and Third Sentinel Nodes Localized With the Use of Fluorescence Imaging Alone | Second sentinel node | 9 Participants |
| Patients With Melanoma or Breast Cancer | Number of Participants Where the First, Second and Third Sentinel Nodes Localized With the Use of Fluorescence Imaging Alone | Third sentinel node | 0 Participants |
Secondary
Adverse Events
Any adverse events related to ICG or sentinel node biopsy.
Time frame: Four weeks
Population: Patients with cutaneous melanoma of extremity who had a sentinel node biopsy
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Patients With Melanoma or Breast Cancer | Adverse Events | 7 participants |