PET Research Committee: Preliminary proposal form
All research studies involving PET scans must be approved by the PET Research Committee and a
costing obtained before submitting a grant. PET studies often require significant technical and/or
scientific input from PET centre staff and we are keen to provide this as part of a scientific
collaboration wherever possible. The nature of any collaboration or other supporting activity should
be clarified at an early stage. If your proposal is complex you may be invited to present/discuss your
application during the monthly committee meeting.
If PET centre staff are not consulted or aware of your grant application prior to submission it cannot
be guaranteed that your study will be supported later.
Please return forms to:
emma.sperring@kcl.ac.uk
Date of proposal form submission:
Provisional start date for the study:
Title of proposed study:
Name of applicant (s):
Department:
Hospital:
Contact number:
Member(s) of the PET Centre initially consulted:
Collaborator/co-investigator in the PET centre:
A: Background 200 words max (with major references)
B: Hypothesis and aims (200 words max)
C: Brief outline of methods (200 words max)
D: Type of imaging involved
PET/CT: yes/no
PET/MR: yes/no
Tracer/s required: (FDG, FLT etc)
Blood sampling/metabolite analysis during scan required: yes/no
E: Approximate number of patients or volunteers
Is the trial single/multicentre?
Healthy volunteers:
Patients:
Number of PET scans/sessions per patient:
F: Estimated length of study
Start:
Finish:
G: Planned funding source
Funding in place: yes/no
Funding from a commercial source: yes/no
Funding application started: yes/no
Funding body/deadline:
H: Data handling
PET scan data analysis input from Clinical PET centre required: yes/no
Transfer of scans externally for central reading required: yes/no
G: Any additional information (e.g. drug trial, IMP trial etc):
Please read the following guidelines which will help clarify the processes,
procedures and approvals required when undertaking PET/CT or PET/MR research in
our centre
GUIDELINES FOR RESEARCHERS UNDERTAKING PET STUDIES
(Revised version – 5th March 2014)
General Points
All communications regarding the study approvals below should be directed to the PET Research Coordinator (currently emma.sperring@kcl.ac.uk ) who can guide you through the processes below. You are
encouraged to seek advice on this process as early as possible.
PET studies are complex and likely to go wrong if not properly planned! You are encouraged to discuss your
project with PET Centre staff at the earliest opportunity.
PET studies often require significant technical and/or scientific input from PET centre staff and we are keen to
provide this as part of a scientific collaboration wherever possible. The nature of any collaboration or other
supporting activity should be clarified at an early stage
If PET centre staff are not consulted or aware of your grant application prior to submission it cannot be
guaranteed that your study will be supported later.
Researchers must be always be present during patient scans, unless arranged otherwise, and must take
responsibility for their patients, including explaining and dealing with issues related to tracer delays/failures
etc.
Arterial lines. If this is required for your study, a cardiology clinical fellow can be assigned to insert lines. The
researcher associated with the PET study (i.e. you) will be responsible for all other aspects of patient care
related to the line before and after it is inserted, including removal of the line.
PET scan costs must be discussed with the PET Centre Service Manager prior to grants being submitted. Note
that most research studies involve non-standard protocols and the cost per scan may be greater than that of a
similar clinical study. If a significant amount of data processing/analysis/blood sampling/metabolite analysis
etc. is required then this will need to be costed separately.
For each patient scan a patient referral should be made and the signed consent form must be available in the
PET Centre prior to the scan. No research PET study will take place without the relevant consent form.
Once the study is underway changes to the scanning protocol and schedule can only be made with the
approval of the ARSAC license holder/study PI as appropriate and/or when the relevant permissions have
been obtained.
SEQUENCE OF EVENTS BEFORE STUDY CAN START
1. Submit Project proposal form to the PET Research Co-ordinator
2. PET staff undertake technical evaluation of project and identify roles (if any) of PET centre staff, the need
for new resources and any requirements/opportunities for collaboration.
3. Study will be discussed at monthly Research Committee Meeting. A decision as to whether or not to
support the study in principle, subject to any questions/issues raised being resolved, will be made at this
time. Any questions/issues raised will be forwarded to the researcher following the meeting.
4. A costing will be worked out by PET Centre Service Manager.
5. A PET centre clinical scientist will be assigned to the study who will co-ordinate and be first point of
contact for all technical aspects of the study
6. Researcher prepares detailed protocol and ensures all other preparations are made in collaboration with
PET centre staff – clinical scientist will arrange ‘Project Setup Meetings‘ as appropriate
7. Researcher obtains all necessary approvals (see list below) in collaboration with PET Research Coordinator and Clinical Scientist
8. Researcher discusses with PET Centre Service Manager/PET technologist to arrange scan scheduling
9. When all approvals and other preparations completed a ‘Startup Meeting’ will be organised. The
scanning protocol and scanning schedule will then be finalised.
10. Final scanning protocol entered on the PET research database, transferred to scanning suite and signed
off by clinical scientist attached to the study. Study entered on CRIS/study folder created.
11. For non-standard protocols a dry run on the scanner with no patient or radioactivity will be performed,
and the clinical scientist assigned to the study should be present for at least the first the scanning session
12. Study begins
13. The clinical scientist will ensure that all data from the study, including images and all associated data (eg
blood samples etc) is archived locally in the PET Centre
NO STUDY CAN START UNTIL ALL THE FOLLOWING APPROVALS HAVE BEEN OBTAINED
All communications regarding the study approvals below should be directed to the PET Research Coordinator (currently emma.sperring@kcl.ac.uk ) who can guide you through the processes below. You are
encouraged to seek advice on this process as early as possible.
Copies of all the relevant documents must forwarded to the PET Centre before study can start
1. PET Research Committee approval
2. Ethics committee approval (or audit/service review approval if appropriate) via IRAS. Note that the
radiation sections of the ethics application (MPE report and risk assessment must be completed and
authorised electronically by a Medical Physics Expert (MPE) and Clinical Radiation Expert (CRE) not by
the researcher! The MPE and CRE must also approve the Patient Information Sheet (PIS) and will not
authorise the ethics form without seeing the PIS. Note that if any amendments are made to the ethics
permission and/or the PIS that relate to the PET part of the study, then these must be reviewed and reauthorised by the MPE and CRE.
3. For certain studies/tracers it may be necessary to obtain an Investigational Medicinal Product (IMP)
license and Clinical Trials Authorization (CTA) from the MHRA. The definition of what constitutes an
IMP is complex – if in any doubt then please seek advice as early as possible.
4. ARSAC committee approval. The ARSAC form is automatically generated and populated from the ethics
form when the IRAS form is completed. Additional paperwork and signatures and a hardcopy submission
is required. The PET research co-ordinator will advise on this.
5. KHP R&D approval. Form populated and generated as part of the IRAS application.
6. Honorary GSTT contracts are required for any non-GSTT researchers involved in carrying out the study
7. IR(ME)R training is required for any staff involved in administering radioactive substances to the subject.
PET Centre can advise on training courses.
8. Radiation Project Approval / Best Practical Means Form / Radiation Risk Assessment are required for all
studies. (For standard protocols these will probably be covered by a generic existing approval)