Magnetic and Indocyanine Green (ICG) Sentinel Lymph Node Mapping in Colorectal Cancer:A Feasibility and Validity Clinical Trial

ABSTRACT: Interventions: This is a multi centre, open label, side-by-side comparator study to assess the safety, feasibility and validity of lymphatic staging using the standard of care lymphadenectomy and histopathology process compared with using investigational products in combination being FerroTrace and ICG for mapping sentinel lymph nodes (SLNs), as an adjunct to the standard of care lymphadenectomy in subjects with colorectal cancer. The study will also investigate the feasibility of assessing lymph nodes for metastasis using FerroTrace enhanced MRI in rectal cancer subjects and in colon cancer subjects at the discretion of the Investigator, with MRI performed when the Investigator believes bowel motion artefacts will not affect the MRI or does not expose the patients to unacceptable COVID risk. A maximum of 40 subjects will be enrolled. Eligible subjects will receive a single dose of 0.4-0.5ml (27mg Fe) of FerroTrace and a single dose of 0.4-0.5ml of ICG(1.25mg) administered via four equal volume endoscopic peri-tumoural submucosal injections each of 1/4 of the dose, administered either separately for subjects part of the MRI protocol, or together during surgery for those not including MRI. Subjects with the optional MRI will receive a pre-injection MRI of the pelvis followed by the endoscopic FerroTrace injections, and a post-injection MRI of the pelvis 2 – 30 h after injection. During surgery, subjects will receive the ICG injections. Subjects not including the MRI will receive the FerroTrace/ICG injections during surgery. For all subjects, the standard of care surgery and lymphadenectomy will be performed. At the surgeon’s discretion, a near infrared (NIR) surgical camera may be used to identify and remove extra-regional LNs they assess to contain FerroTrace and ICG. An ex vivo sur Primary outcome(s): Composite outcome - Safety: Percentage of subjects with adverse events overall, and by severity and relatedness, graded according to Common Terminology Criteria for Adverse Events (CTCAE) v5.0.[Day -1 - the day before surgery Day 0 - the day of surgery Day 14 - 14 days after surgery] Study Design: Purpose: Diagnosis; Allocation: Non-randomised trial; Masking: Open (masking not used);Assignment: Other;Type of endpoint: Safety/efficacy

DISEASE(S): Surgery-other Surgery,Colorectal Cancer,Cancer-bowel-back Passage (rectum) Or Large Bowel (colon)

PROVIDER: 2472341 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR