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

NCT01902953 | Completed Phase 2 Results

• 1 other identifier: 2013-02-05
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Colon Cancer; Rectal Cancer

Keywords

Sentinel lymph nodes; colon cancer; rectal cancer; immunohistochemistry

Outcome Measures

Primary Outcomes (1)

• Efficacy of Lymphoseek for Detection of Sentinel Nodes

  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.

  0-7 days

Secondary Outcomes (1)

• Localization Rates

  On the day of surgery i.e. day 0 of index operation

Study Arms (1)

Lymphoseek and VBD SLN dissection

EXPERIMENTAL

Ex-Vivo Lymphoseek and VBD SLN dissection

Drug: Lymphoseek and VBD Sln dissection

Interventions

Lymphoseek and VBD Sln dissection DRUG

See detailed description of study design

Also known as: SLN dissection

Lymphoseek and VBD SLN dissection

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Maimonides Medical Center: lead

Study Sites (1)

Maimonides medical Center

Brooklyn, New York, 11219, United States

Location

MeSH Terms

Conditions

Colonic Neoplasms; Rectal Neoplasms

Interventions

technetium-diethylenetriaminepentaacetic acid-mannosyl-dextran

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Results Point of Contact

• Title: Danny Sherwinter
• Organization: Maimonides

dsherwinter@maimonidesmed.org

7182837952

Study Officials

• Danny A Sherwinter, MD

  Maimonides Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending, Surgery

Study Record Dates

• First Submitted: May 29, 2013
• First Posted: July 18, 2013
• Study Start: March 1, 2013
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: June 23, 2021
• Results First Posted: May 20, 2020

Record last verified: 2021-06

Locations

US (1)