Lymphoseek® as Lymphoid Tissue Targeting Agents in Colon Cancer(CNC)
Status:
Completed
Trial end date:
2016-06-01
Target enrollment:
Participant gender:
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.