Fluorescence-guided surgery in children
Research type
Research Study
Full title
Fluorescence-guided surgery: investigating micro-dosing of Indocyanine Green for intraoperative perfusion assessment in infants, children, and teenagers.
IRAS ID
325104
Contact name
Vanshree Patel
Contact email
Sponsor organisation
Great Ormond Street Hospital NHS Trust
Duration of Study in the UK
5 years, 0 months, 0 days
Research summary
Fluorescence-guided surgery (FGS) is a new imaging technique to help surgeons recognise and assess anatomical structures during procedures, with the aid of injected dyes (such as Indocyanine Green, or ICG). This is widely used in adult procedures, where micro-dosing of ICG (using very small doses, below the range currently used in clinical practice) has shown promising results (good fluorescence during surgery). The use of ICG is growing in paediatric surgery; in the past few years, ICG injection and detection of its fluorescence have helped surgeons assess perfusion (blood flow) of the gut and bladder. However, ICG use in kids is not regulated by clear protocols on its injection dose and there is no research to investigate the lowest dose needed. Moreover, the safety profile in different paediatric populations (different ages and weights) is under-explored. The cameras to detect the fluorescence can use the near-infrared or the short wave-infrared spectra and we want to investigate what is best for intraoperative fluorescence visualisation.
We aim to define the procedure-specific lowest dose of ICG (mg/kg) to be used in children to effectively assess the perfusion of anatomical structures. In addition, the cameras used to detect intraoperative fluorescence can use the near-infrared (NIR-1, 600-900nM wavelength) or the short wave-infrared (SWIR, 900-1700nM, wavelength) spectra and we want to investigate which is best for intraoperative fluorescence visualisation. Cohorts of children undergoing different surgical procedures will receive small escalating doses of ICG; fluorescence would then be detected during the procedure by two different cameras and its intensity and usefulness would be assessed. Every study within this project would take place at Great Ormond Street Hospital, where we would recruit stable participants between 0-18 years of age; our first study will focus on infants (0-1 year), the second on children (1-12 years), and the third one on teenagers(12-18 years).
REC name
London - Bloomsbury Research Ethics Committee
REC reference
23/LO/0743
Date of REC Opinion
7 Nov 2023
REC opinion
Further Information Favourable Opinion