Utility of ML10-PET imaging for Apoptosis Evaluation

• Research type

  Research Study

• Full title

  An open-label study to evaluate the utility of the apoptosis imaging biomarker [18F]ML-10 to assess the response to chemotherapy in patients with non Hodgkin's lymphoma.

• IRAS ID

  49465

• Contact name

  Paul Matthews

• Sponsor organisation

  GlaxoSmithKline Research and Development Ltd

• Eudract number

  2010-019832-11

• ISRCTN Number

  N/A

• Research summary

  All cells in the body are programmed to die naturally after a certain period of time. This type of cell death known as apoptosis is lost in cancer cells allowing them to live longer. A number anti-cancer drugs including new drugs under development restore this capability of natural cell death to cancer cells. However, our ability to monitor this has so far been limited, as we need several invasive biopsies to confirm this. The behaviour or function of a compound in the body can be assessed by Positron emission tomography (PET) scanning. A very small amount of radioactive substance called a 'tracer' can be measured and followed in real-time with PET scans, giving us insights in to body function. In this study, we plan to use PET scans to measure and follow the behaviour of radioactive ML10 ([18F] ML10) in patients with Non Hodgkin??s Lymphoma (NHL) receiving standard chemotherapy. ML10 has been shown to be taken up by cells undergoing programmed cell death in animals and has also been confirmed to be safe in human beings. We will follow the behaviour of [18F] ML10 in tumours and measure the amount of this agent that is taken up in tumours. This will allow us to make an assessment of amount of cells dying due to restoration of this natural cell death. We will also compare this with the extent to which tumours shrink with treatment. If we confirm from this study that we can measure cell death after treatment using [18F] ML10 PET images, this will allow us to monitor cell death after treatment. We can use PET scans in future to monitor new treatments and find out if the drugs are doing, what they are supposed to do.

• REC name

  London - West London & GTAC Research Ethics Committee

• REC reference

  10/H0707/41

• Date of REC Opinion

  13 Jul 2010

• REC opinion

  Further Information Favourable Opinion