Overview of techniques involved (e.g. 'omics')
5. Imaging techniques
Imaging is another
group of techniques that can be used as biomarkers in medicines development.
Common imaging techniques in medicine are:
- Magnetic Resonance Imaging (MRI)
- Computed Tomography (CT)
- Positron Emission Tomography (PET)
The techniques are usually not invasive which means that no biological samples are collected. They can provide information about whole tissues, tumours or organs.
MRI and CT measurements are often used in cancer patients to assess tumour size in Phase III clinical trials. In 2011, the EMA gave a regulatory approval on the use of MRI to select Alzheimer’s patients with early stage disease into clinical trials . This was the first imaging biomarker for Alzheimer’s to be given a positive opinion by a regulatory agency.
Very few imaging biomarkers have been qualified (i.e. validated) for early phases of development, although some non-validated methods can be used in exploratory clinical trials.
However, as with the newer ‘omics’approaches, much effort is put into research on imaging biomarkers for medicines development. For example, the Innovative Medicines Initiative (IMI) has helped to setup an international collaboration of academics and industry called QuIC-ConCePT (Quantitative Imaging in Oncology: Connecting Cellular Processes to Therapy, http://www.quic-concept.eu/). QuIC-ConCePT aims to develop imaging biomarkers that can show earlier and more accurately how patients’ tumours react in cancer clinical trials.