GE-135-003 18F Phase 2 Study

• Research type

  Research Study

• Full title

  A Phase 2, Open-label, Proof-of-concept Study to Assess the Ability to Detect Tumours and Angiogenesis via the Expression of avb3 Integrin Receptors by [18F]AH111585 PET Imaging.

• IRAS ID

  58780

• Contact name

  Norbert Avril

• Sponsor organisation

  GE Healthcare

• Eudract number

  2008-005219-16

• ISRCTN Number

  N/A

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  The study will involve adult patients who have an initial diagnosis or recurrence of a tumour(s) of 2.0 cm or larger in diameter (except for thyroid tumours that are required to be 1.5 cm or larger) and are scheduled to have surgery or a biopsy. The study aims to measure the uptake of the imaging agent [18F]AH111585 (also known by the USAN approved name fluciclatide) in tumours and new blood vessels in tumours. Images using [18F]AH111585 will be acquired using a Positron Emission Tomography (PET) scanner. Participants will receive an injection of the study drug [18F]AH111585 and then receive a PET scan that will take a maximum of 2 hours 15 mins. Following the injection the participant will also receive safety monitoring. This will involve vital signs, a physical examination, ECG and blood tests. Blood samples will also be taken the day before the injection of study drug [18F]AH111585 and a day after. Within two weeks after the PET scan, the participant will receive either a biopsy of the tumour tissue or surgery to remove the entire tumour as part of their standard of care. The participant will return to the hospital, three and six weeks after the PET scan for blood samples to test for antibodies to the study drug ([18F]AH111585). The participant's involvement in the study will then end.

• REC name

  London - Brent Research Ethics Committee

• REC reference

  10/H0717/93

• Date of REC Opinion

  6 Dec 2010

• REC opinion

  Further Information Favourable Opinion