GE-135-004 18F-AH111585 Phase 2 Study

• Research type

  Research Study

• Full title

  A phase 2, open-label test-retest study to assess the reproducability of quantitative measurements of 18F uptake by solid tumours using PET imaging following intravenous administration of AH111585 (18F) Injection.

• IRAS ID

  18229

• Sponsor organisation

  GE Healthcare Ltd

• Eudract number

  2008-003835-18

• ISRCTN Number

  not issued

• Research summary

  This study aims to see how well the drug AH111585 (18F) can detect tumours. Images will be taken using a Positron Emission Tomography (PET) scanner on two different days and the images will be compared to see if a similar amount of drug has been taken up by the cells, and to see if the quality of the images is reproducible.The study results may help understand if the drug can be used to see how tumours and the cells growing around them respond to medicine. Images taken at different timepoints after the injection will determine when enough study drug binds to a tumour to produce a quality image.Up to ten patients will be asked to give consent for the study doctor to retrieve part of a biospy sample for testing, which would have been previously collected as part of their normal standard of care. This will be an optional part of the study. The study will be performed in the UK and India and funded by GE Healthcare. Up to 45 patients will be recruited in total. Patients diagnosed with particular tumour types will be selected by their oncologist according to the study entry criteria. Patients attend a screening visit, 2 PET imaging days and 1 follow up visit 6 weeks after the second imaging day. At the PET imaging visits, subjects will receive a single injection of the drug, have a computed tomography (CT) scan to position the body under the camera, and up to 3 serial PET scans. Safety measurements will be made on the imaging days at 2 hours post injection of the drug. Blood samples will be taken, a limited physical exam and ECG will be performed. At baseline and 6 weeks after the second imaging day, blood samples will be taken for antibody testing.

• REC name

  London - West London & GTAC Research Ethics Committee

• REC reference

  09/H0707/20

• Date of REC Opinion

  21 Apr 2009

• REC opinion

  Further Information Favourable Opinion