GALA-BIDD
Research type
Research Study
Full title
Improving the intra-operative diagnosis of high-grade glioma using a fluorescence biomarker
IRAS ID
147504
Contact name
Colin Watts
Contact email
Sponsor organisation
Cambridge University Hospitals Foundation Trust and the University of Cambridge
Research summary
Brain tumours (gliomas) are classified as low and high-grade. Correctly distinguishing high-grade glioma (HGG) from low-grade glioma (LGG) during surgery can influence the surgical procedure, enhancing resection and improving survival. The aim of this study is to understand if it is possible to use an existing drug (Gliolan®) to confirm the glioma grade during surgery.
Gliolan® is a drug which contains 5-aminolevulinic acid hydrochloride (5-ALA). It is licensed in the UK for use in patients with malignant HGG to aid in visualisation of tumour tissue. Gliolan® is converted to a substance that glows red when exposed to ultra-violet light in brain tumour cells, allowing the surgeon to see the tumour more clearly and safely remove as much tumour as possible.
It is not yet clear if Gliolan® could also act as a biomarker to diagnose the grade of the tumour during surgery. There are no biomarkers available for use during surgery that provides biological information about the tumour. Therefore, the surgeon has to rely on the gross appearance of the disease coupled with analysis and preliminary diagnosis of samples during surgery (peri-operative) to guide the operation.
The study will examine tumour samples routinely collected during surgery and correlate the peri-operative and post-operative histological diagnoses. This analysis will validate if the presence of Gliolan® visible fluorescence is a pragmatic intra-operative diagnostic surgical biomarker of high-grade disease. The primary endpoint is the percentage of patients with visible fluorescence that have confirmed high-grade disease. The secondary endpoint is to establish the percentage of eligible patients who are without visible fluorescence but classified with post-operative high-grade disease and determine distribution of high grade disease in the tumour tissue.
A total 80 patients with glioma WHO grade II (query transforming to III/IV), III, IV, visible fluorescence and post-operative confirmation of disease grade will be recruited.
REC name
South Central - Hampshire B Research Ethics Committee
REC reference
14/SC/1126
Date of REC Opinion
11 Jul 2014
REC opinion
Favourable Opinion