Lymphoseek® as Lymphoid Tissue Targeting Agents in Colon Cancer(CNC)
Condition: Colon Cancer; Rectal Cancer
MeSH terms: Rectal Neoplasms; Colonic Neoplasms
Intervention: Lymphoseek and VBD Sln dissection
Intervention description: See detailed description of study design
Phase: Phase 2
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 16.0
Sex: All
Minimum age: 18 Years
Maximum age: 85 Years
Healthy volunteers: No
Keywords: Sentinel lymph nodes; colon cancer; rectal cancer; immunohistochemistry

Summary:

      45 patients undergoing a colon (large bowel/intestine)removal operation for the diagnosis of
      colon cancer will be included in this study. During colon operation the affected portion of
      the colon is removed. In addition, lymph nodes are included in the specimen and evaluated by
      a pathologist. Analysis of the lymph nodes in the specimen are important because this is an
      important aspect of determining the stage of the cancer.

      Once the standard technique is used for the colon removal operation and the specimen is
      removed it will be injected with two drugs to help identify the lymph nodes. One is a blue
      dye and the other a radiotracer. The colon and ALL of the lymph nodes will then be sent for
      the standard pathologic evaluation. The patient themselves will never be injected with these
      drugs being used for research.

      Following the standard lymph node evaluation, an additional pathologist at an outside
      research facility will further examine the lymph nodes in the specimen using more in depth
      techniques which are above and beyond the standard of care.

      The results of all the pathologic tests will be conveyed to the surgeon of record to help in
      their decision making regarding further treatment.

      The study hypothesis is that radiotracer will be at least as effective as blue dye in
      identifying the lymph nodes most likely to harbor cancer cells (sentinel nodes). Once
      identified, these sentinel nodes can then undergo a more in depth review leading to improved
      staging of colorectal cancer and more accurate treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          -  The patient has provided written informed consent with Health Insurance Portability
             and Accountability Act (HIPAA) authorization.

          -  The patient has a diagnosis of colon cancer and is a candidate for surgical
             intervention, with ex vivo lymph node mapping being a part of the surgical plan.

          -  The patient is at least 18 years of age at the time of consent.

          -  The patient has an Eastern Cooperative Oncology Group (ECOG) performance status of
             Grade 0 - 2.

          -  The patient has a clinical negative node status at the time of study entry (i.e.,
             Tis-4, N0, M0).

        Exclusion Criteria:

          -  The patient has clinical or radiological evidence of metastatic cancer including
             palpably abnormal or enlarged lymph nodes.

          -  The patient has undergone node basin surgery of any type or radiation to the nodal
             basin(s).

          -  The patient has undergone radiation therapy or chemotherapy treatment within the
             previous 45 days.