Sentinel Lymph Node Biopsy Findings in Patients With Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: Lymphoseek; Sulfur Colloid
Intervention description: Subjects will receive a single intradermal injection of Lymphoseek followed by SPECT imaging conducted in two phases: initial sequential planar imaging at 30 to 60 second intervals for the first 60 minutes and repeated at 90 minutes and 120 minutes, as indicated, for identification of the SLN followed by SPECT/CT for higher resolution imaging in transaxial, coronal, and sagittal planes. Subjects will then proceed to surgery for lymphatic mapping. Lymphoseek positivity will be based upon radioactivity counts derived from the application of the handheld gamma probe ex vivo. Tumor resection or mastectomy will be performed according to standard procedures.; Subjects will receive a single intradermal injection of 99mTc-SC followed by SPECT imaging conducted in two phases: initial sequential planar imaging at 30 to 60 second intervals for the first 60 minutes and repeated at 90 minutes and 120 minutes, as indicated, for identification of the SLN followed by SPECT/CT for higher resolution imaging in transaxial, coronal, and sagittal planes. Subjects will then proceed to surgery for lymphatic mapping. 99mTc-SC positivity will be based upon radioactivity counts derived from the application of the handheld gamma probe ex vivo. Tumor resection or mastectomy will be performed according to standard procedures.
Phase: Phase 4
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 40.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Sentinel Node

Summary:

      To compare the kinetics and efficacy of two functionally different diagnostic agents,
      Lymphoseek (CD206 receptor targeted) and 99mTc-Sulfur Colloid (SC) (Sulfur Colloid
      non-specific mapping agent) in intraoperative lymphatic mapping (ILM) and Sentinel Lymph Node
      Biopsy (SLNB).
    

Eligibility criteria:

        Inclusion Criteria:

          -  The subject must be female and 18 years of age or older.

          -  The subject must be a preoperative clinical Tis, T1, T2, T3, T4, as well as clinical
             N0 and clinical M0 breast cancer

          -  The subject must have a diagnosis of primary breast cancer.

          -  The subject must be a candidate for surgical intervention, either with lumpectomy and
             SLNB or with mastectomy and SLNB, as the treatment of her breast cancer.

          -  The subject must have an Eastern Cooperative Oncology Group (ECOG) performance status
             of Grade 0 - 2

          -  The subject must provide written informed consent with Health Insurance Portability
             and Accountability Act (HIPAA) authorization before participating in the study

        Exclusion Criteria:

          -  The subject has clinical or radiological or pathologic evidence of metastatic cancer,
             including any abnormal or enlarged clinical palpable lymph nodes or core
             biopsy/surgical biopsy/fine-needle-aspiration evidence of malignant cell within any
             lymph nodes.

          -  The subject has a known hypersensitivity to vital blue dye (VBD) in a case where vital
             blue dye was planned for use during SLNB.

          -  The subject has a positive pregnancy test or is lactating.

          -  The subject has had prior surgery to the indicated breast or axilla.