Real time tissue validation using NIR fluorescence imaging: Surgery
Research type
Research Study
Full title
Development and validation of an optical imaging system for Intraoperative near Infrared Fluorescence guidance in breast cancer tumour resection and reconstructive surgery.
IRAS ID
222629
Contact name
Daniel Leff
Contact email
Sponsor organisation
Imperial College London
Duration of Study in the UK
1 years, 2 months, 0 days
Research summary
This study is funded by the National Institute of Health Research (NIHR) and aims to test how efficiently a near infrared (NIR) fluorescence sensitive camera system detects subtle difference between healthy and cancerous tissues and monitors blood flow. A multispectral imaging (MSI) camera will be also used along with the light source of this system for tissue classification and blood volume and oxygenation measurements.
The Xenon light source (MAX-303, Asahi Spectra) is CE marked, operating below National Standards Institute safety limits and provides broad spectrum illumination covering UV(ultraviolet), VIS(visible) and NIR/IR (near infrared/infrared) wavelengths. The control of output is implemented with an incorporated filter wheel. For the acquisition of Fluorescence images, a clinically approved contrast agent, Indocyanine Green (ICG) will be intravenously injected with a standard clinical dose, which is well below the toxicity level (2 mg/kg). Contrast in fluorescence images is attributed to the leakage of the ICG-bounded blood proteins in tumour vessels. Moreover, the MSI camera will acquire images of reflected white light at different wavelengths (colours) from tissue. The degree of reflection at different wavelengths is associated with blood oxygenation and volume. The total additional time to the scheduled operation will be approximately 15 minutes
These imaging techniques will be applied to open/semi-endoscopic procedures of breast excision conserving surgeries or reconstruction at Charing Cross Hospital, upon informed consent of patients, and reviewed off-line. Tumour boundaries and blood flow will be assessed with the analysis of fused fluorescence-white light images, with which multispectral images will be aligned to compare the results. Histological tests, where available, will cross-validate the findings.
The use of this affordable and compact imaging system, in contradiction with conventional imaging, such as MRI, could guide surgeons in real time, facilitate decision making and thus improve surgery outcomes and decrease recurrence rates. Therefore, the potential benefits to the patients would be prolonged lives of better quality and to the hospital, more efficient use of human and financial resources.
REC name
London - Bromley Research Ethics Committee
REC reference
18/LO/1362
Date of REC Opinion
8 Oct 2018
REC opinion
Further Information Favourable Opinion