Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
M.D. Anderson Cancer Center
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.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Age 18 or older
Willing to provide informed consent
Biopsy proven colon or rectal cancer
No distant metastases
You may not be if
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
