Magnetic Particle-ICG Lymph Node Mapping in Colorectal Cancer

M.D. Anderson Cancer Center

Status and phase: Withdrawn; Phase 2; Phase 1

Conditions: Colorectal Cancer

Treatments: Drug: indocyanine green (ICG); Device: FerroTraceTM

Study type: Interventional

Funder types: Other

Identifiers

NCT05092750

2021-0479

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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*

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

FerroTraceTM (magnetic tracer)

Experimental group

Description:

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.

Treatment:

Drug: indocyanine green (ICG)

Device: FerroTraceTM