Quality Control Procedure

Introduction

The quality control (QC) procedures described here reflect the current requirements for PET-CT centres to become accredited by the NCRI PET Core Lab and the additional QC tests that must be performed for participation in multicentre PET-CT studies.

Please note: most multicentre trials have additional requirements for standardisation of patient preparation, PET-CT acquisition and image reconstruction parameters and therefore centres participating in multicentre PET trials should always refer to the latest copy of the trial protocol and the imaging manual which can be obtained from the Trial Co-ordinator.

Please contact us for any queries regarding site accreditation.

Quality Control Procedures for Multicentre 18F-FDG-PET-CT Studies

This purpose of this procedure is to establish a consistent method for performing the site accreditation procedures for PET Centres joining the NCRI PET Clinical Trials Network.

This procedure applies to all PET Centres currently within the NCRI PET Clinical Trials Network and any new applicants. This procedure only covers site accreditation for participation in non- or semi-quantitative clinical oncology studies using PET.

The co-ordination function of the NCRI PET Clinical Trials Network is performed through the NCRI PET Core Lab based at the PET Imaging Centre, St Thomas' Hospital. All technical aspects of the site accreditation process, including quality control and data transfer are performed by medical physicists at the NCRI PET Core Lab.

Site Accreditation Process:

Before a PET centre can participate in NCRI multicentre trials involving PET it must undergo the formal site accreditation process by the NCRI PET Core Lab. Scanning as part of the clinical trials must not start until written confirmation of compliance with the technical requirements as specified in the QC document is received from the NCRI PET Core Lab.

The following steps should be completed as part of the accreditation process:

  1. The NEMA image quality phantom must be filled and scanned following the procedure in the Image Quality Assessment Procedure. For the initial scanner testing, this will usually be performed at a pre-arranged site visit by a physicist from the UK PET Core Lab.
  2. The site must complete the PET/CT Quality Control Form and return a signed copy to the Core Lab.
  3. Two anonymised patient studies acquired and reconstructed using the proposed study protocol should be transferred to the Core Lab for technical and clinical review. All studies sent to the Core Lab must be in DICOM format and include the attenuation corrected PET, CT and non- attenuation corrected PET.
  4. Procedures for anonymisation and transferring of patient studies from the scanning PET Centre to the UK PET Core Lab must be established. Validation of these procedures can be performed when transferring the anonymised patient studies in step 3.
  5. The PET Centre must have a documented quality assurance (QA) programme in place including quality control (QC) procedures for the PET/CT scanner, weighing scales and radionuclide calibrator that conform to the manufacturer’s recommendations and the latest UK or EU guidance/legislation where applicable. To demonstrate this fulfils the minimum requirements for accreditation sites will need to submit copies of the following:
    1. A copy of the scanner QA schedule and example results covering daily, weekly, monthly, quarterly and annual QC tests. This should include both PET and CT components of the scanner.
    2. A copy of the most recent annual CT QC report (or the acceptance testing report for new systems).
    3. A copy of the most recent calibration certificate or QC report for the patient weighing scales.
    4. 8 weeks of SUV data measured using a uniform 18F or 68Ge cylinder to demonstrate the scanner stability.

Annual Renewal:

To maintain on-going accreditation by the UK PET Core Lab, sites will be required to submit data for review on an annual basis. This is to ensure continued compliance and that no significant changes have been made to the local protocol. Sites will therefore be required to submit the following to the Core Lab:

The site accreditation process must also be repeated by a PET Centre in the following situations:

It is the responsibility of the PET centre to inform the Core Lab of any upgrades to the scanner hardware or software prior to the upgrade. If the upgrade is likely to affect the image quality the site will be required to repeat the phantom scans before continuing to scan patients as part of the trials.

Any Questions regarding these steps should be directed to the Trials Physicist at the NCRI PET Core Lab.