FLICC II
Research type
Research Study
Full title
Feasibility Study for Fluorescence Lymph Node Imaging in Colorectal Cancer Study - FLICC II
IRAS ID
238844
Contact name
Manish Chand
Contact email
Sponsor organisation
University College London
Duration of Study in the UK
1 years, 6 months, 16 days
Research summary
Surgery for colorectal cancer involves taking out the cancer and the associated lymph nodes which are the main pathway for tumour spread. Current standard techniques involve a methodological excision of these lymph nodes but nevertheless this approach is not guided. Indocyanine green is a fluorescent dye used for over 10 years in clinical practice. It may enable high precision guidance, highlighting the correct lymph nodes so they can be removed accurately. This is hypothesized to lead to improved survival for patients with colorectal cancer.
The main aim is to determine the validity and accuracy for indocyanine green fluorescence imaging to demonstrate lymphatic drainage and sentinel node identification in colon cancer in order to establish the ability of ICG fluorescence to guide proper oncologic resections in colorectal cancer.
This is a phase II, open label single-site nonrandomized trial that will be based in the University College Hospital in London. Patients with colorectal cancer undergoing surgical resection with curative intent will be enrolled. Standard pre-operative evaluation will be executed. Intraoperative evaluation will assess lymphatic drainage mapping, sentinel node identification and intraoperative localization of tumours. Postoperative evaluation of perfusion of the colorectal anastomosis will be performed through proctoscopy on the first 4 postoperative days. Standard follow-up will be executed. Predicted enrolment period will be of one year.REC name
London - Stanmore Research Ethics Committee
REC reference
18/LO/0789
Date of REC Opinion
14 Aug 2018
REC opinion
Further Information Favourable Opinion