13C- Pyruvate DNP Hyperpolarised Magnetic Resonance Imaging Metabolic Assessment of Disease
试验速览
- 阶段
- 不适用
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Pyruvate to Lactate conversion following the injection of Hyperpolarised 13C- Pyruvate
研究概览
简要总结
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.
详细描述
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;
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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.
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MRI Safety
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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).
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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.
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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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 years or over
- •Suspected Prostate Cancer/Renal Cancer/Rectal Cancer/Pancreatic Cancer
- •No current renal impairment or an eGFR within a standard reference value if there is a history of renal disease.
- •Subject able to comply with study procedures and provide informed consent.
- •Patient is willing to undergo MRI/Hyperpolarised 13C-Pyruvate MRI or with other nuclei and substrate (where appropriate).
- •Eastern Cooperative Oncology Group Performance Status (ECOG) of 0 or 2
排除标准
- •Contraindication to MRI (e.g cardiac pacemaker)
- •Contraindication to MR contrast agents
- •Breast Feeding
- •Deranged renal function (eGFR<30) -
研究组 & 干预措施
Prostate Cancer
Patients with biopsy-proven prostate cancer will be recruited for an additional Hyperpolarised MRI scan prior to any treatment
干预措施: Hyperpolarised MRI (Diagnostic Test)
Renal Cancer
Patients with biopsy-proven renal cell carcinoma will be recruited for an additional Hyperpolarised MRI scan prior to any treatment
干预措施: Hyperpolarised MRI (Diagnostic Test)
Breast Cancer
Patients with biopsy-proven breast cancer will be recruited for an additional Hyperpolarised MRI scan prior to any treatment
干预措施: Hyperpolarised MRI (Diagnostic Test)
Lymphoma
Patients with biopsy-proven lymphoma will be recruited for an additional Hyperpolarised MRI scan prior to any treatment
干预措施: Hyperpolarised MRI (Diagnostic Test)
结局指标
主要结局
Pyruvate to Lactate conversion following the injection of Hyperpolarised 13C- Pyruvate
时间窗: 3 years
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
次要结局
- Pyruvate to Lactate conversion as an imaging biomarker(3 years)
- Hyperpolarised 13C MRI as an imaging biomarker to assess response(3 years)
- Correlation of Hyperpolarised 13C- Pyruvate MRI with genetic markers(3 years)
研究者
Shonit Punwani
Principal Investigator
University College, London