LightPath®️ and Head&Neck Cancer
Research type
Research Study
Full title
A clinical study to evaluate 18F FDG LightPath®️ for intra operative assessment of tumour resection margins in Head and Neck Cancer
IRAS ID
261804
Contact name
Qamar Akbar
Contact email
Sponsor organisation
Lightpoint Medical Ltd
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
00, 00
Duration of Study in the UK
0 years, 7 months, 30 days
Research summary
This study is a prospective, single-centre clinical trial to examine the performance and safety of 18F-FDG LightPath for intra operative assessment of tumour resection margins in Head and Neck Cancers in comparison to standard of care intra operative Frozen Section Analysis and post operative histopathological analysis.
The study consists of 2 sequential groups of 10 subjects:
Group 1 will optimise the site’s procedures and acquisition of intra-operative LightPath scans and imaging parameters.Group 2 will perform LightPath scans using the optimised procedure and imaging parameters developed in Group 1 and measure the agreement between LightPath images and intra-operative frozen section analysis and post-operative histopathology. The intra-operative LightPath Images will be used to inform the surgeons about a close or a positive margin in an attempt to achieve better guided cancer surgery and complete tumour excision with clear margins. The study site will use the local criteria considered standard of care to guide decisions to act on positive margins. It will be the Investigator’s decision to choose whether to act based upon the intra-operative LightPath Images.
REC name
West Midlands - Solihull Research Ethics Committee
REC reference
19/WM/0116
Date of REC Opinion
5 Jun 2019
REC opinion
Further Information Favourable Opinion