Sentinel Lymph Node Biopsy Using Peritumoral Injection With Blue Dye Confirmation
Status and phase
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Details and patient eligibility
About
We continue to collect information in support of the hypothesis that the histology of the first draining lymph node (sentinel node) accurately predicts the histology of the rest of the axillary lymph nodes.
Full description
Using a technique combining Technetium-99 sulfur colloid and Lymphazurin Blue Dye, we have established that the sentinel node predicts the pathology results of the rest of the axillary lymph nodes. This minimally invasive technique, which can be readily performed under local anesthesia, makes the need for full axillary lymph node dissection unnecessary for most patients. If the sentinel node is negative, no further surgery is necessary. If positive, a complete axillary node dissection is performed. In addition, the injections are made while the patient is under anesthesia, reducing the physical and psychological pain that accompanies injections done pre-operatively.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
- Breast cancer requiring lymph node evaluation
- Clinically negative lymph nodes in the axilla
- Willing participation following an informed consent process
Exclusion criteria
- Patients with clinically positive lymph nodes
- Pregnancy (if a pregnant female should be diagnosed with breast cancer an exception would be considered on a case to case basis)
- Previous axillary lymphadenectomy
Trial design
Primary purpose
Allocation
Interventional model
Masking
699 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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