Magnetic Particle-ICG Lymph Node Mapping in Colorectal Cancer

Study Overview
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Brief Summary
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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.

Detailed Description
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PRIMARY: To determine the feasibility of Sentinel Lymph Node (SLN) mapping using novel magnetic tracers (FerroTrace) and indocyanine green (ICG) for colorectal cancer. 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: Feasibility: Number of registered patients who complete all study procedures with at least one sentinel node identified. 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: The identification rate and number of FerroTrace-positive lymph nodes for each patient. 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.

Official Title
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Magnetic Particle-ICG Lymph Node Mapping in Colorectal Cancer

Conditions
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Colorectal Cancer

Intervention / Treatment
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* Device: FerroTraceTM
* Drug: indocyanine green (ICG)


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Age 18 or older Willing to provide informed consent Biopsy proven colon or rectal cancer No distant metastases Exclusion criteria: Serious medical comorbidities or other contraindications to surgery +/- adjuvant therapy as determined by the treatment team Previous pelvic radiotherapy or radiotherapy planned prior to surgery Allergy or intolerance to iron oxide compounds Iron overload disorder Allergy or intolerance to iodides Pregnant or lactating women*

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FerroTraceTM (magnetic tracer)<br>a special type of fluorescent dye called indocyanine green (ICG) during surgery can help surgeons find the lymph nodes that the cancer is most likely to have spread to in colorectal cancer patients. | Device: FerroTraceTM<br>* A magnetic<br>Drug: indocyanine green (ICG)<br>* Given by SC injection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the feasibility how the Sentinel Lymph Node (SLN) mapping by using novel magnetic tracers (FerroTrace) and using the indocyanine green (ICG) for colorectal cancer. |  | through study completion, an average of 1 year |