Optical Molecular Imaging of Microdoses of NAP in Lungs

• Research type

  Research Study

• Full title

  Exploratory clinical study of microdosing NAP for optical molecular imaging in human lungs

• IRAS ID

  98904

• Contact name

  Kevin Dhaliwal

• Eudract number

  2011-006169-17

• Research summary

  Seriously ill patients may develop a complication called acute lung injury (ALI), a form of inflammation in which lung tissue is filled bflud containing white blood cells called neutrophils. ALI is common and is often fatal (for example in the USA it is estimated that 190,000 patients develop ALI per annum, of whom 75,000 die). No pharmacological treatment has been shown to improve ALI. Data from animal models and patients strongly suggest that neutrophils are central to disease progression. However no bedside methods exist to rapidly and accurately determine in seriously ill patients, if neutrophils are present and if they are releasing damaging enzymes such as elastase. As such, the investigating team have developed and synthesised to clinical grade, an imaging agent called NAP (Neutrophil Activation Probe) that detects activated neutrophils and also the damaging enzyme, human neutrophil elastase (HNE). We have extensively tested NAP in animal models for efficacy and safety. It reliably detects activated neutrophils and is not toxic. NAP is a small molecule that is delivered in tiny doses (called microdoses) to areas of inflammation in human lungs through a bronchoscope. The activity of NAP is visualised by imaging though a tiny camera that is also introduced through the bronchoscope. This camera system is now widely used throughout the world in over 150 sites. We therefore aim to test the utility and safety of NAP in an exploratory clinical study. The study involves the delivery of NAP to 6 healthy volunteers followed by delivering NAP to 6 patients in ICU with suspected ALI. In the healthy volunteers study, healthy male volunteers recruited from the University of Edinburgh will be invited to participate. In the ICU study, patients will be recruited from the ICU in the Royal Infirmary of Edinburgh. If the study (which is supported by the Medical Research Council) demonstrates safety and also the ability to image activated neutrophils, our intention is to design future studies in patients with ALI.

• REC name

  Scotland A REC

• REC reference

  12/SS/0004

• Date of REC Opinion

  31 Jan 2012

• REC opinion

  Favourable Opinion