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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2013 by Maimonides Medical Center
Sponsor:
Information provided by (Responsible Party):
Maimonides Medical Center
ClinicalTrials.gov Identifier:
NCT01902953
First received: May 29, 2013
Last updated: July 16, 2013
Last verified: July 2013
  Purpose

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 Intervention Phase
Colon Cancer
Rectal Cancer
Drug: Ex-Vivo Lymphoseek and VBD Sln dissection
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
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

Resource links provided by NLM:


Further study details as provided by Maimonides Medical Center:

Primary Outcome Measures:
  • Efficacy [ Time Frame: 0-7 days Postoperatively ] [ Designated as safety issue: No ]
    Concordance of in vivo detection rates of Lymphoseek and VBD in excised lymph nodes as tissue phenotype is confirmed by histology.

  • Contrast of per agent identified sentinel lymph nodes versus all removed lymph nodes [ Time Frame: 0-7 days Postoperatively ] [ Designated as safety issue: No ]
    Assessment of the excised lymph node(s) to confirm the presence/absence of tumor metastases in all nodes and a contrast of pathology findings in per agent-found nodes versus all non-agent-based removed nodes.


Secondary Outcome Measures:
  • Localization rates, time to localization [ Time Frame: On the day of surgery i.e. day 0 of index operation ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 45
Study Start Date: March 2013
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ex-Vivo Lymphoseek and VBD SLN dissection
Ex-Vivo Lymphoseek and VBD SLN dissection
Drug: Ex-Vivo Lymphoseek and VBD Sln dissection
See detailed description of study design

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01902953

Contacts
Contact: Danny A Sherwinter, MD 7182837952 Dsherwinter@MaimonidesMed.org
Contact: Julya Fuzaylova 7182838656 jfuzaylova@maimonidesmed.org

Locations
United States, New York
Maimonides medical Center Recruiting
Brooklyn, New York, United States, 11219
Contact: Danny A Sherwinter, MD         
Principal Investigator: Danny A Sherwinter, MD         
Sponsors and Collaborators
Maimonides Medical Center
Investigators
Principal Investigator: Danny A Sherwinter, MD Maimonides Medical Center
  More Information

No publications provided

Responsible Party: Maimonides Medical Center
ClinicalTrials.gov Identifier: NCT01902953     History of Changes
Other Study ID Numbers: 2013-02-05
Study First Received: May 29, 2013
Last Updated: July 16, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Maimonides Medical Center:
Sentinel lymph nodes
colon cancer
rectal cancer
immunohistochemistry

Additional relevant MeSH terms:
Colonic Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Colonic Diseases
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases

ClinicalTrials.gov processed this record on September 16, 2014