[11C]choline and [18F]choline in prostate cancer PET-CT imaging

• Research type

  Research Study

• Full title

  A Cancer Research UK Phase II Trial to compare [11C]choline and [18F]choline each given as a single administration via intravenous injection for imaging patients with metastatic prostate cancer.

• IRAS ID

  30249

• Contact name

  Michael O'Doherty

• Sponsor organisation

  Cancer Research UK

• Eudract number

  2008-004828-23

• ISRCTN Number

  xx

• Research summary

  A Cancer Research UK Phase II Trial to compare [11C] choline and [18F] choline each given as a single administration via intravenous injection for imaging patients with metastatic prostate cancer. This clinical trial is comparing two radioactive tracers, [11C] choline and [18F] choline, in their ability to detect metastatic lesions (cancer which has spread to other parts of the body) in prostate cancer patients who have at least 4 metastatic lesions identified by a diagnostic bone scan. The study scans will be scored and then compared against each other and against diagnostic imaging. [11C] choline has been used more than [18F] choline in previous clinical trials. Both tracers are manufactured shortly before use, and only remain active for a short time, limiting access to a few specialist Radiology departments. [11C] choline has to be used quickly, within 20 minutes, whereas [18F] choline can be used for nearly 6 times longer. If [18F] choline is as good as [11C] choline, access to PET imaging for diagnosis of prostate cancer spread it will be available for more patients in more parts of the UK by using [18F] choline because it lasts longer. This will be the first direct comparison of these two tracers and will determine which tracer should be used for further research. Patients must not have received hormonal therapy or any other therapeutic treatment for prostate cancer. Scans are performed on one day and patients must fast from 6am until 3.30pm (patients with diabetes cannot participate). Patients remain in the centre for 6-7 hours and need to lie still on the scanner for three series of scans, lasting a total of 2.5 hours. Patients return to the clinic for a safety check-up within a week. The study is funded by Cancer Research UK. 55 patients will be enrolled at The Clinical PET Centre, St. Thomas?? Hospital, London.

• REC name

  London - Westminster Research Ethics Committee

• REC reference

  10/H0802/11

• Date of REC Opinion

  1 Apr 2010

• REC opinion

  Further Information Favourable Opinion