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

Ferronova Pty Ltd0 个研究点目标入组 40 人开始时间: 2021年6月15日最近更新: 2024年6月3日

适应症

试验速览

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•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.

•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
•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)

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