Comparison of Use of Indocyanine Green and 99mTc-labeled Radiotracer for Axillary Lymphatic Mapping in Patients With Breast Cancer
| Status: | Completed |
|---|---|
| Conditions: | Breast Cancer, Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 3/14/2019 |
| Start Date: | February 17, 2015 |
| End Date: | February 2019 |
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.
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.
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.
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.
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
We found this trial at
1
site
Cleveland, Ohio 44195
Phone: 216-636-2843
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