Lymphoseek® as Lymphoid Tissue Targeting Agents in Colon Cancer(CNC)
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.
|Colon Cancer Rectal Cancer||Drug: Lymphoseek and VBD Sln dissection||Phase 2|
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||Prospective, Open-Label, Ex Vivo Comparison Study of Lymphoseek® and Vital Blue Dye (VBD) as Lymphoid Tissue Targeting Agents in Colon Cancer(CNC) Patients' Excised Colon w/ Abdominal Lymphatic Bed|
- Efficacy [ Time Frame: 0-7 days Postoperatively ]Concordance of in vivo detection rates of Lymphoseek and VBD in excised lymph nodes as tissue phenotype is confirmed by histology.
- Localization rates, time to localization [ Time Frame: On the day of surgery i.e. day 0 of index operation ]Secondary evaluations will include localization rates (identification of any hot and/or blue node), degree of localization (node number/patient's ex vivo total tissue), counts localized per node, and time to localization and stabilization.
|Study Start Date:||March 2013|
|Estimated Study Completion Date:||June 2016|
|Estimated Primary Completion Date:||June 2016 (Final data collection date for primary outcome measure)|
Experimental: Lymphoseek and VBD SLN dissection
Ex-Vivo Lymphoseek and VBD SLN dissection
Drug: Lymphoseek and VBD Sln dissection
See detailed description of study design
Other Name: SLN dissection
Show Detailed Description
Please refer to this study by its ClinicalTrials.gov identifier: NCT01902953
|United States, New York|
|Maimonides medical Center|
|Brooklyn, New York, United States, 11219|
|Principal Investigator:||Danny A Sherwinter, MD||Maimonides Medical Center|