OPTIC
Research type
Research Study
Full title
Optical PD-L1 imaging using Quantitative Fluorescence Endoscopy in locally advanced esophageal cancer using durvalumab-680LT: a phase I multicenter feasibility and safety study
IRAS ID
1008643
Contact name
Julia Cook
Contact email
Sponsor organisation
University Medical Center Groningen
Eudract number
2020-004714-35
Clinicaltrials.gov Identifier
Research summary
This study aims to find out if we can view a particular protein called PD-L1 that can be present in many solid tumours including cancers of the oesophagus. PD-L1 is important because it is a target for new immunotherapy treatments that work by helping our own immune systems recognise and attack cancer cells. Previous studies have shown that patients with higher PD-L1 expression have a better response to immunotherapy and a subsequent survival benefit.
Currently, tests where tumour tissues are viewed under a microscope are used to assess whether PD-L1 is present in tumours. These tests are not always very accurate so new methods are needed to measure PD-L1 expression. This would help us to select the patients who are most likely to benefit from immunotherapy. We are investigating a new method called quantitative fluorescence endoscopy. This uses an antibody called durvalumab that is made in a laboratory and is designed to bind to PD-L1. By attaching a fluorescent molecule to durvalumab we have made a fluorescent tracer called durvalumab-680LT. This can be injected into the bloodstream of patients with oesophageal cancer where it binds to the PD-L1 protein. Patients then have an endoscopy to locate and visualise their tumour. By using a fibre in the endoscope that gives out a specific frequency of light, it is possible to 'see' the areas of tumour that contain PD-L1.
We are studying this technique to see if we can calculate the amount of PD-L1 from the level of fluorescence and to see if the levels of PD-L1 protein in the tumour are different before and after chemotherapy. This will help us to discover the best time to measure PD-L1 and when immunotherapy might be most effective against the tumour.
Up to 36 patients from 2 hospitals in the UK and the Netherlands will be asked to take the fluorescent tracer and have an endoscopy before the start of and after completion of their chemotherapy treatment. They will be in the study for about 16 weeks.
REC name
HSC REC A
REC reference
24/NI/0010
Date of REC Opinion
28 Jun 2024
REC opinion
Further Information Unfavourable Opinion