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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01902953
Recruitment Status : Completed
First Posted : July 18, 2013
Results First Posted : May 20, 2020
Last Update Posted : May 20, 2020
Information provided by (Responsible Party):
Danny A Sherwinter, Maimonides Medical Center

Brief 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.

Condition or disease Intervention/treatment Phase
Colon Cancer Rectal Cancer Drug: Lymphoseek and VBD Sln dissection Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : March 2013
Actual Primary Completion Date : June 2016
Actual Study Completion Date : June 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Lymphoseek

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Efficacy of Lymphoseek for Detection of Sentinel Nodes [ Time Frame: 0-7 days ]
    Number of Participants in Concordance of in vivo detection rates of Lymphoseek and VBD in excised lymph nodes as tissue phenotype is confirmed by histology.

Secondary Outcome Measures :
  1. Localization Rates [ Time Frame: On the day of surgery i.e. day 0 of index operation ]
    Number of Participants with secondary evaluations will include localization rates (identification of any hot and/or blue node),

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01902953

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United States, New York
Maimonides medical Center
Brooklyn, New York, United States, 11219
Sponsors and Collaborators
Maimonides Medical Center
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Principal Investigator: Danny A Sherwinter, MD Maimonides Medical Center
  Study Documents (Full-Text)

Documents provided by Danny A Sherwinter, Maimonides Medical Center:
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Responsible Party: Danny A Sherwinter, Attending, Surgery, Maimonides Medical Center Identifier: NCT01902953    
Other Study ID Numbers: 2013-02-05
First Posted: July 18, 2013    Key Record Dates
Results First Posted: May 20, 2020
Last Update Posted: May 20, 2020
Last Verified: May 2020
Keywords provided by Danny A Sherwinter, Maimonides Medical Center:
Sentinel lymph nodes
colon cancer
rectal cancer
Additional relevant MeSH terms:
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Rectal Neoplasms
Colonic Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Intestinal Diseases
Colonic Diseases
Digestive System Diseases
Gastrointestinal Diseases
Rectal Diseases