Cyclotek is licenced to manufacture Investigational Medicinal Products (IMP's) for use in clinical trials and, under some circumstances, a named patient program. In Australia, latter is referred to as the Special Access Scheme. In general terms the following conditions apply.

  • All PET tracers other than FDG are currently considered by TGA to be IMPs, and can therefore be only used in Clinical Trials, under the Special Access Scheme (SAS) or through an Authorised Prescriber Scheme.
  • All IMPs compounded by Cyclotek are manufactured to GMP standards under a licence from TGA. Where a Pharmacopeia Monograph exists, Cyclotek manufactures to that specification.
  • All Clinical Trials with IMPs must have ethics approval in keeping with NH&MRC guidelines, with an appropriate Clinical Trials Notification (CTN) lodged with TGA.
  • SAS A or B schemes may be used, depending on the tracer and application
    SAS A – https://www.tga.gov.au/form/special-access-scheme
    SAS B – https://www.tga.gov.au/form/special-access-scheme
  • Cyclotek must be supplied with copies of the CTNs or appropriate SAS forms
  • Cyclotek provides a regular consolidated report to TGA on the use of IMPs, which identifies the sites using IMPs

In addition to the above, Cyclotek and the imaging site need to have a Supply Agreement in place. This can be in one of several formats, which we would be glad to discuss with you. We can also provide you with more detailed information on the regulatory requirements mentioned above. In New Zealand, rebates are available for certain IMP’s (see Clinical Rebates New Zealand tab)

Clinical Rebates New Zealand

CancerClinical Indication
15. Brain Cancer
(Using 18F-FET)
Differentiation between high and low grade gliomas- For the differentiation of recurrent
tumours from radiation necrosis
16. Breast Cancer
(Using 18F-NaF)
Initial staging in high risk breast cancer (Clinical Stage IIIA or higher) or :- Initial staging
in clinical stage I-IIB breast cancer with symptoms of bone pain or elevated alkaline
phosphatase levels suggesting the presence of bone metastases- Restaging of all
stage disease with symptoms of bone pain or elevated alkaline phosphatase levels
strongly suggestive of the presence of bone metastases
17. Prostate Cancer
(Using 18F-NaF)
Staging or high risk prostate cancer defined as:* Stage T1 and PSA > 20 or* Stage T2 and PSA > 10 or* Gleason Score ≥ 8 or T3, T4 disease or
* Any disease stage with symptoms strongly suggestive of bone metastases