Magnetic Particle-ICG Lymph Node Mapping in Colorectal Cancer

Colorectal Cancer Clinical Trial

Official title: 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Status Withdrawn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. ;

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

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• Status: Withdrawn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