Gliomas, the most frequent primary brain tumours, are life-threatening rare tumours with poor prognosis. Currently, CT and MRI are necessary to identify brain lesions in general. Limitations of these methods are that MRI and CT are often not able to detect low-grade gliomas or distinguish glioma from other tumours or other pathologies. Moreover, MRI and CT are not able to grade the glioma stage. To date, glioma confirmation and grading still have to happen during brain surgery with biopsies and histopathology. However, reliable, fast, differential diagnosis with high sensitivity and specificity and glioma grading are of utmost importance since they have immediate impact on patient management and the type of therapy: the earlier the disease is diagnosed, the more likely is a longer survival.
In consequence, there is a significant unmet medical need for a fast, reliable method to perform differential diagnosis of glioma with high sensitivity as well as specificity, which is widely available and economically viable at the same time.
End-users of the final diagnostic product (currently under development, clinical phase III in preparation) used for the imaging technique in combination with SPECT, will be patients with glioma and patients with reliably excluded glioma. Both can be guided to different therapies for their particular suffering without prior brain biopsy. Further, beneficiaries and buyers will be hospitals and ambulatory centres specialized on brain tumour diagnostics and potentially treatment.
Although the results of the Phase II study were positive, these results need to be confirmed in the larger Phase III study. Until this has been completed and the results have been analysed, the full impact of this project cannot be properly assessed.
