Cancer Clinical Trial
Official title:
13C- Pyruvate DNP Hyperpolarised Magnetic Resonance Imaging Metabolic Assessment of Disease
NCT number | NCT03687645 |
Other study ID # | 205839 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | July 1, 2017 |
Est. completion date | June 30, 2020 |
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.
Status | Recruiting |
Enrollment | 25 |
Est. completion date | June 30, 2020 |
Est. primary completion date | June 30, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility |
Inclusion Criteria: 1. Age 18 years or over 2. Suspected Prostate Cancer/Renal Cancer/Rectal Cancer/Pancreatic Cancer 3. No current renal impairment or an eGFR within a standard reference value if there is a history of renal disease. 4. Subject able to comply with study procedures and provide informed consent. 5. Patient is willing to undergo MRI/Hyperpolarised 13C-Pyruvate MRI or with other nuclei and substrate (where appropriate). 6. Eastern Cooperative Oncology Group Performance Status (ECOG) of 0 or 2 Exclusion Criteria: 1. Contraindication to MRI (e.g cardiac pacemaker) 2. Contraindication to MR contrast agents 3. Pregnancy 4. Breast Feeding 5. Deranged renal function (eGFR<30) - |
Country | Name | City | State |
---|---|---|---|
United Kingdom | University College London | London |
Lead Sponsor | Collaborator |
---|---|
University College, London | Cancer Research UK |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Pyruvate to Lactate conversion following the injection of Hyperpolarised 13C- Pyruvate | Following the injection of Hyperpolarised 13C- Pyruvate, the rate of conversion of pyruvate to lactate will be measured using the lactate spectral peak height to produce metabolic map. Such metabolic maps generate the first-in-human images of tumour metabolism in patients with prostate, renal, breast, lymphoma cancers and cardiac disease | 3 years | |
Secondary | Pyruvate to Lactate conversion as an imaging biomarker | Pyruvate to lactate conversion rate has the potential to be used as an imaging biomarker. The higher rate of conversion within a tumour could be used to risk stratify the disease and as a prognostic tool. |
3 years | |
Secondary | Correlation of Hyperpolarised 13C- Pyruvate MRI with genetic markers | Hyperpolarised 13C- Pyruvate MRI results and pyruvate to lactate conversion rate is going to be correlated with genetic markers of disease aggressiveness to investigate whether there is any creation between the two. The genetic data for this analysis will be used when collected as part of routine clinical care |
3 years | |
Secondary | Hyperpolarised 13C MRI as an imaging biomarker to assess response | Using Hyperpolarised 13C - Pyruvate MRI, the changes in pyruvate to lactate conversion rate following chemotherapy, radiotherapy, surgery and ablative technique will be assessed. These changes will then be correlated with clinical outcome measures that are routinely used in patients' managements to investigate the potential of hyperpolarised 13C - Pyruvate MRI for response monitoring in different cancer subtypes. |
3 years |
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