This phase I/II trial tests the safety and side effects of FerroTrace and indocyanine green and whether they work in lymph node mapping during surgery for colorectal cancer. Using FerroTrace in combination with the indocyanine green dye may help surgeons better detect where cancer may have spread.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT05092750.
PRIMARY OBJECTIVES:
I. To determine the feasibility of sentinel lymph node (SLN) mapping using novel magnetic tracers (iron conjugated polymers in saline suspension [FerroTrace]) and indocyanine green (ICG) for colorectal cancer.
II. To evaluate safety by assessing short term toxicity associated with colonoscopic peritumoral injection of novel magnetic nanoparticles (FerroTrace) and ICG for colorectal cancer.
SECONDARY OBJECTIVE:
I. 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 hematoxylin and eosin (H&E) staining pathology tests.
OUTLINE:
Patients receive FerroTrace and ICG by injection into tissues around the tumor during standard of care surgery.
After completion of surgery, patients are followed up at 30 days.
Lead OrganizationM D Anderson Cancer Center
Principal InvestigatorGeorge Jae-Shik Chang
