Colorectal Cancer
Conditions
Brief 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.
Detailed 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.
Interventions
DEVICEFerroTraceTM
A magnetic
DRUGindocyanine green (ICG)
Given by SC injection
Sponsors
M.D. Anderson Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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\*
Design outcomes
Primary
| Measure | 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 |
Outcome results
None listed