Lymphoseek® as Lymphoid Tissue Targeting Agents in Colon Cancer(CNC)

Completed · Phase 2

Conditions studied: Colon Cancer, Rectal Cancer

In brief

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.

Key facts

Study ID

NCT01902953

Run by

Maimonides Medical Center

People needed

16

Starts

2013-03-01

Expected to finish

2016-06-01

Last updated by the study team

2021-06-23

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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.

Where it is running

• Maimonides medical Center — Brooklyn, New York, United States

Full record on ClinicalTrials.gov

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