SDT using MRgFUS in GBMs
Research type
Research Study
Full title
A phase 1 study to Evaluate the Safety and Feasibility of Sonodynamic Therapy with 5- Aminolevulinic Acid Using the ExAblate MRI-Guided Focused Ultrasound in the Treatment of Cerebral Glioblastomas
IRAS ID
1012243
Contact name
Wladyslaw Gedroyc
Contact email
Sponsor organisation
Imperial College Healthcare NHS Trust
ISRCTN Number
ISRCTN14636207
Research summary
Despite progress made in many cancer treatments, high-grade gliomas (HGG) remain an extraordinary challenge. Their aggressive and infiltrative nature, the limited efficacy and inherent risk of surgical resection combined with radiotherapy, and the difficulty in delivering anticancer drugs to the brain, make the prognosis for patients with gliomas grim. Therefore, new and less-invasive alternatives to existing procedures are needed.
Sonodynamic therapy (SDT) represents an emerging approach that offers the possibility of noninvasively eradicating solid tumours. It involves the delivery of a non-toxic chemical agent that selectively accumulates into target areas and the subsequent exposure of the targeted tissue to relatively low-intensity ultrasound. These procedures (sensitization and ultrasound exposure) are both per se harmless, but, when combined, result in activation of the chemical agent and subsequent cytotoxic events limited to the target tissue volume. SDT offers significant advantages because ultrasound energy can be tightly focused and delivered through the intact skull to deep areas of the brain.
5-ALA is a PpIX precursor that selectively accumulates in HGGs because of an enhanced uptake and metabolism from tumour cells. It is used for intra-operative guidance in surgery as tumour tissue shows fluorescence under certain light conditions due to PpIX accumulation, as compared to the normal surrounding parenchyma. It is therefore a good candidate for SDT. 5-ALA can exert sonodynamic effects against HGGs, as it has been shown in several pre-clinical studies.
Unpublished pre-clinical data on a safety experiment conducted at the University of Virginia showed that SDT with 5- ALA was not exerting a toxic effect to the normal brain.
The idea of the present study is to investigate the antitumor effects of SDT in patients affected by HGGs attained with low-frequency focused ultrasound in combination with the systemic administration of 5-ALA.REC name
East of England - Cambridge Central Research Ethics Committee
REC reference
25/EE/0263
Date of REC Opinion
2 Apr 2026
REC opinion
Further Information Favourable Opinion