A PET scan study of [18F]-FBA-A20FMDV2; ver 1

• Research type

  Research Study

• Full title

  Validation and Dosimetry Study of [18F]-FBA-A20FMDV2 PET Ligand for avß6 in Healthy Subjects and in the Lungs of Idiopathic Pulmonary Fibrosis (IPF) Subjects (PETAL study). HMR code (13-503)

• IRAS ID

  141982

• Contact name

  Malcolm Boyce

• Contact email

  vparker@hmrlondon.com

• Sponsor organisation

  GlaxoSmithKline

• Research summary

  GSK2634673F (the tracer) is a new substance that might help with research into idiopathic pulmonary fibrosis (IPF). We’re doing this study to see if it will attach (‘bind’) to damaged areas of lung. We hope to use it to measure lung damage and see how quickly IPF is progressing, and to help develop new medicines. It’s never been given to humans before.

  The tracer is labelled with radioactivity. We’ll give a tiny dose of tracer, by injection, to healthy volunteers and patients with IPF, and use a positron emission tomography (PET) scan to see where the tracer binds. We’ll compare the results in healthy volunteers and patients, and compare results in patients with those of another test (a special type of x-ray) that measures lung damage.

  We’ll test the tracer in men aged at least 45, and women aged at least 55, as follows.
  * Part A – up to 6 healthy people
  * Part B – up to 8 healthy people
  * Part C – up to 20 patients with IPF

  Healthy participants will have 1 dose of tracer and 1 PET scan. They’ll make 3 outpatient visits and take up to 8 weeks to finish the study.

  Patients will have up to 2 doses of tracer and up to 2 PET scans. They’ll make up to 4 outpatient visits, and take up to 10 weeks to finish the study.

  A pharmaceutical company (GlaxoSmithKline) is funding the study.

  Participants will be recruited and screened at Hammersmith Medicines Research, London, and have PET scans at Imanova, London. We’ll recruit healthy people by: advertising (newspaper, radio, and websites); by word of mouth; from volunteer databases; and via our websites. Hospital consultants will help us recruit patients with IPF.

• REC name

  London - Brent Research Ethics Committee

• REC reference

  13/LO/1792

• Date of REC Opinion

  20 Dec 2013

• REC opinion

  Further Information Favourable Opinion