Magnetic Particle-ICG Lymph Node Mapping in Colorectal Cancer

Status Withdrawn

Clinical Trial Summary

Study to determine the feasibility of Sentinel Lymph Node (SLN) mapping using novel magnetic tracers (FerroTrace) and indocyanine green (ICG) for colorectal cancer; and to evaluate safety by assessing short term toxicity associated with colonoscopic peritumoral injection of novel magnetic nanoparticles (FerroTrace) and ICG for colorectal cancer.

Clinical Trial Description

PRIMARY: 1. To determine the feasibility of Sentinel Lymph Node (SLN) mapping using novel magnetic tracers (FerroTrace) and indocyanine green (ICG) for colorectal cancer. 2. To evaluate safety by assessing short term toxicity associated with colonoscopic peritumoral injection of novel magnetic nanoparticles (FerroTrace) and ICG for colorectal cancer. SECONDARY: 1. To determine the additional positive diagnostic value of adding sentinel lymph node mapping to lymphadenectomy by assessing the SLNs with detailed immunochemistry versus the normal H&E staining pathology tests. PRIMARY END POINTS: 1. Feasibility: Number of registered patients who complete all study procedures with at least one sentinel node identified. 2. Safety: Rate of any grade III or greater toxicity attributable to FerroTrace injection, evaluated using the Common Terminology Criteria for Adverse Events (CTCAE) v. 5.0. Adverse events according to general peri-operative complications. SECONDARY ENDPOINTS: 1. The identification rate and number of FerroTrace-positive lymph nodes for each patient. 2. Incidence of pathological upstaging of LN metastasis status by the addition of (non-routine) serial H&E and immunohistochemistry in the pathological assessment of identified FerroTrace-positive lymph nodes. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05092750
Study type	Interventional
Source	M.D. Anderson Cancer Center
Contact
Status	Withdrawn
Phase	Phase 1/Phase 2
Start date	September 15, 2021
Completion date	August 29, 2023

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