Status:
COMPLETED
Lymphoseek® as Lymphoid Tissue Targeting Agents in Colon Cancer(CNC)
Lead Sponsor:
Maimonides Medical Center
Conditions:
Colon Cancer
Rectal Cancer
Eligibility:
All Genders
18-85 years
Phase:
PHASE2
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 re...
Detailed Description
This study is a single center, open-label, within patient's tissue ex vivo comparative study of Lymphoseek (Lymphoseek (Technetium Tc 99m Tilmanocept) is a radiotracer that accumulates in lymphatic ti...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2016
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT01902953
Start Date
March 1 2013
End Date
June 1 2016
Last Update
June 23 2021
Active Locations (1)
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1
Maimonides medical Center
Brooklyn, New York, United States, 11219