None listed
Conditions
Brief summary
The purpose of this study is to evaluate the safety of a new magnetic tracer (FerroTrace) and an infrared dye (Indocyanine Green - ICG) to be used together in colorectal cancer surgery to find the lymph nodes the cancer is most likely to have spread to (the sentinel lymph nodes). This study will also evaluate the feasibility and accuracy of the new magnetic tracer (FerroTrace) and infrared dye (ICG) for finding the sentinel lymph nodes. If the sentinel nodes are clear of cancer, there is a very high probability the cancer has not spread. Finally, the study will also investigate whether the new tracer enables better detection of cancer cells in lymph nodes on Magnetic Resonance Imaging (MRI) before surgery. Who is it for? You may be eligible to join this study if you are aged between 18 and 75 years, have a confirmed diagnosis of primary colorectal cancer and are scheduled for surgery to remove the primary tumour. Study details All participants will undergo their surgery to remove the primary tumour as originally scheduled, with the addition of receiving the new magnetic tracer (Ferrotrace) and the infrared dye (ICG) during the surgery. Participants will then be monitored for 14 days after the surgery for complications. It is hoped that this research project will demonstrate the new method is safe and feasible, and can enable larger follow on trials to determine if the new method improves staging accuracy and can improve patient outcomes.
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 met
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 survey of the excised specimen using a magnetometer probe and near infrared camera will be performed to locate specimen SLNs. Histopathology will be as per standard of care for all LNs in the lymphadenectomy specimen, plus more detailed ultra-staging of SLNs using serial slicing and immunochemistry. The fidelity of the intervention is ensured by only specialists with endoscopy accreditation being used for the injection of the investigational product, and a video being recorded of the injection for monitoring purposes.
Sponsors
Ferronova Pty Ltd
Study design
Allocation
Non-randomised trial
Intervention model
Other
Primary purpose
Diagnosis
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Subject has provided written informed consent. 2. Subject is between 18 and 75 years of age (inclusive) at the time of providing informed consent. 3. Subject with a confirmed diagnosis of primary colon or rectal cancer with no distal metastasis. 4. Subject is scheduled for lymphadenectomy as part of the surgical plan. 5. Subject has a clinical negative node status (i.e., cN0) at the time of providing informed consent. 6. If applicable, subjects must be willing to use methods of contraception as deemed adequate by the Investigator to be eligible for, and continue participation in, the study. 7. In the opinion of the Investigator, the subject can complete the study in compliance with the protocol and is able to comply with the requirements of the study protocol. 8. Subjects with an ECOG performance status of Grade 0–2.
Exclusion criteria
1. Subject has had preoperative radiation therapy to the pelvis or abdomen. 2. Subject has received a Feraheme® (ferumoxytol) injection within the past 180 days. 3. Subject has a known or suspected history of allergies, hypersensitivity, or intolerances as follows: a. Iron compounds b. Polyacrylamide c. PEG d. Iodine compounds e. Known or suspected hypersensitivity to the investigational product, or to any ingredients of the investigational product. 4. Subject known to have haemochromatosis. 5. Subject has a co-morbid condition with an estimated life expectancy of <180 days at the time of consent. 6. Subjects who are pregnant, trying to become pregnant, or lactating at time of screening. 7. Subject has participated in another investigational drug study within 30 days of scheduled surgery. 8. Subject considered for inclusion in the MRI cohort has one or more absolute contraindications to MRI scanning as per Investigator judgement. 9. Subjects with an eGFR of < 30 ml/min/1.73m2. 10. Subject has inability or unwillingness to comply with all follow-up through to the end of the study, and/or unwilling to allow review of medical records in accordance with local regulatory requirements at time of consent. 11. Investigator determines that the subject is not suitable for study participation for any other reason (e.g., Subject has had previous pelvic surgery, or lymphatic function that is impaired in the Investigator’s judgment)
Outcome results
None listed