Cancer Clinical Trial
Official title:
13C- Pyruvate DNP Hyperpolarised Magnetic Resonance Imaging Metabolic Assessment of Disease
Metabolic changes related to disease are the precursor to anatomical changes in tissues.
Currently the imaging methods routinely used in clinical practice look at the anatomical
changes. Whilst these methods are very helpful in making clinical decisions, they are far
from being perfect. Early disease can be missed because these methods are not sensitive
enough and it is not clear whether disease is present or not. Additionally, it is also
difficult to know whether disease it aggressive or non-aggressive.
Hyperpolarised MRI is a new imaging tool that may allow addressing these deficiencies in
current imaging technology. The process of hyperpolarisation allows the production of an
injectable solution that can produce signal on a standard MRI scanner inferring information
about the metabolism occurring at a particular location. This technology has only just become
available for clinical use.
The initial stages of evaluation require the investigators to refine and develop the new
imaging protocols so that assessment can be made as to whether consistent results can be
achieved. Additionally, refining the imaging protocol could also aid in identifying where the
best potential future clinical use of this technology should be targeted.
Within this application the investigators aim to try out hyperpolarised MRI in a number of
different cancers and also see whether it is useful to assess cardiac metabolism. The
investigators will be using 13C-labelled metabolites (for this study 13C- pyruvate) which
will allow interrogation of glucose metabolism. The derangement of glucose metabolism is
common to a number of disease processes.
The main objectives of this work are to generate proof-of-concept first-in-human metabolic
imaging data using hyperpolarised MRI for patients with prostate cancer (n=15), renal (n=5),
breast cancer (n=5), lymphoma (n=5) and cardiac diseases (n=5). Each cohort will provide
sufficient value for high-impact publication and the essential preliminary data for
subsequent individual grant applications. The findings will be correlated with conventional
imaging and with clinical patient details and where applicable patient outcome. The study
will take 3 years.
The main ethical, legal and management issues from the study are;
1. Hyperpolarised Injectable The investigators will be using a product to inject into
patients that will be manufactured on site. This will be a GMP facility to ensure
sterility. The methodology to do this is new. The investigators will have established
safety through evaluation of the processes within the facility with institutional
approval prior to utilisation of the product in patients. In addition, any product that
is to be injected will be taken through a quality control module which will determine
its pH, temperature, concentration and provided these are within specified safe
parameters will allow the investigators to inject into the patient. The QC module itself
will be validated/qualified prior to its use. Finally, solution produced for injection
will go through a sterile filter and also be sent for culture. Patients will be
monitored throughout the study and will be followed up after examination.
2. MRI Safety
1. The investigators will be using new MRI coils that allows transmission of
radiofrequency signals into the body and collect them. A new coil is required
because the investigators need them to be tuned to the frequency of 13C (usually
MRI uses 1H).
2. The investigators will be using new MRI software that has been programmed in house
to generate the signals. This software has undergone in-house and institutional
approval processes to confirm that it is safe for human use.
3. Recruitment An information leaflet be dispatched to the volunteer and subsequent contact
will be made to assess interest in participation and discuss arrangement for the study.
35 patients will be recruited in the first instance in one of the following ways: A. Through
identification at the relevant multidisciplinary team meeting (MDT) B. Patients with
confirmed cancer or heart conditions who are attending for a clinical MRI scan (or from an
imaging list) as part of standard care at UCLH.
C. Direct referral from clinical colleagues D. Cancer or cardiology in-patients who are well
enough and meet the recruitment criteria
Only 25/35 patients will be injected with the hyperpolarised solution. The remaining 10/35
(prostate cancer patients) will allow the investigators to optimise the MRI clinical scan
technique and use of an endorectal MRI coil (to be inserted into the back passage). This
optimisation will ensure that when patients with prostate cancer are evaluated with the
hyperpolarised injectable, the best chance of detecting the hyperpolarised MR signal is
provided.
(4) Consent Patients will have had information > 24hours in advance of consenting to study
and having the research MRI. Consent will be obtained by a member of the research team
trained in taking consent. Interpretation services will be made available if the patient is
not fluent in spoken or written English.
(5) Data Management
1. Unexpected Findings: Any unexpected findings in participants with known cancer (e.g.
unknown metastatic disease) will be directly communicated to the clinical team.
2. Confidentiality of Data: All data will be collated by the chief investigator and
research team. Electronic data and images will be held on password protected databases
and will be pseudo anonymised to avoid identification of patients. Adherence will be
made to the data protection act 1998. Patient data will never leave UCLH. This system is
compliant with UCLH data protection regulations.
(6) Patient Burden/Benefit Patients will need to attend the hospital for the additional
scan required for this study. The total amount of time that they will spend within the
study is approx. 4 hours (including consent, preparation and monitoring). Patients will
reimbursed for transport costs to enable them to attend for their scan.
The investigators will where possible try to coincide the scan with a clinical
appointment to minimise repeated attendances to hospital. There will be no direct
benefit to patients of having undergone this scan. However, participants will contribute
towards potential societal benefit if the technique is successful. The investigators
will keep the doctors of the patients informed with the study results which can then be
communicated to participants.
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