Axillary Reverse Mapping
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Breast Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 9/8/2018 |
| Start Date: | May 2007 |
| End Date: | May 2019 |
ARM: Axillary Reverse Mapping
We hypothesize that variations in anatomic location of the arm lymphatic drainage system put
the arm lymphatics at risk for disruption during a SLNB and / or ALND. Therefore, mapping the
drainage of the arm during the procedure would decrease the likelihood of inadvertent
disruption of the lymphatics and the subsequent development of lymphedema. A combination of
radioactivity and blue dye will be used.
the arm lymphatics at risk for disruption during a SLNB and / or ALND. Therefore, mapping the
drainage of the arm during the procedure would decrease the likelihood of inadvertent
disruption of the lymphatics and the subsequent development of lymphedema. A combination of
radioactivity and blue dye will be used.
Mapping Procedure:
Each patient will receive an injection of 1.0 mCi of technetium-99m sulfur colloid into the
normal breast tissue surrounding the primary cancer or biopsy cavity directed subareolar or
around the tumor.
If the radioactive SLN cannot be located prior to incision via gamma probe then the blue dye
will be used in the breast either in the subareolar plexus or peritumorally at the discretion
of the surgeon. For this contingency (expected to occur <3% of the time), the blue dye will
be used in the breast (and NOT the arm), as the prime concern is locating the SLN for
staging.
If the blue dye is unnecessary to find the sentinel node draining from the breast, then it
will be injected dermally in the upper inner arm along the Biceps groove of the ipsilateral
arm in order to locate the draining lymphatics from the arm. No more than 5cc of blue dye
will be injected in either the subareolar plexus, peritumorally (intraparenchymal or
dermally), or dermally in the patient's ipsilateral arm dependent upon the contingencies
stated above. Site of all injections (radioactivity and/or blue dye) will be recorded.
Each patient will receive an injection of 1.0 mCi of technetium-99m sulfur colloid into the
normal breast tissue surrounding the primary cancer or biopsy cavity directed subareolar or
around the tumor.
If the radioactive SLN cannot be located prior to incision via gamma probe then the blue dye
will be used in the breast either in the subareolar plexus or peritumorally at the discretion
of the surgeon. For this contingency (expected to occur <3% of the time), the blue dye will
be used in the breast (and NOT the arm), as the prime concern is locating the SLN for
staging.
If the blue dye is unnecessary to find the sentinel node draining from the breast, then it
will be injected dermally in the upper inner arm along the Biceps groove of the ipsilateral
arm in order to locate the draining lymphatics from the arm. No more than 5cc of blue dye
will be injected in either the subareolar plexus, peritumorally (intraparenchymal or
dermally), or dermally in the patient's ipsilateral arm dependent upon the contingencies
stated above. Site of all injections (radioactivity and/or blue dye) will be recorded.
Inclusion Criteria:
- 18-100 years old
- Not pregnant or breastfeeding
- Breast cancer requiring lymph node evaluation for the ipsilateral or contralateral
breast OR prophylactic mastectomy
- Willing participation following an informed consent process
Exclusion Criteria:
- Patient < 18 y/o or > 100 y/o
- Pregnant or breastfeeding
- If a pregnant female should be diagnosed with breast cancer an exception would be
considered on a case to case basis.
We found this trial at
1
site
529 West Markham Street
Little Rock, Arkansas 72205
Little Rock, Arkansas 72205
(501) 686-7000
Principal Investigator: V. Suzanne Klimberg, MD
University of Arkansas for Medical Sciences The University of Arkansas for Medical Sciences (UAMS) in...
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