CancerNCT03687645
Hyperpolarised 13C-Pyruvate MRI Study
A study testing Hyperpolarised MRI in people with Cancer and Cardiovascular Diseases, run by University College, London at 1 site in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Cancer, Cardiovascular Diseases
- What is being tested?
- Hyperpolarised MRI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Jul 2017to 30 Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Contraindication to MRI (e.g cardiac pacemaker)
- Contraindication to MR contrast agents
- Pregnancy
- Breast Feeding
- Deranged renal function (eGFR<30) -
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
University College London
London
Dr Shonit Punwani
Dr Arash Latifoljar
About this study
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.
Read more
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.
Read the detailed description
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;
- 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.
- MRI Safety
- 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).
- 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.
- 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.
- 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
- Unexpected Findings: Any unexpected findings in participants with known cancer (e.g. unknown metastatic disease) will be directly communicated to the clinical team.
- 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.
- Conditions
- Cancer, Cardiovascular Diseases
- Being tested
- Hyperpolarised MRI
- Medical subject headings
- Neoplasms, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyperpolarised MRIDiagnostic test
Hyperpolarized (HP) 13C MR is an advanced imaging technique that allows monitoring of dynamic metabolic processes non-invasively. Hyperpolarisation is a process that provides dramatic gains in sensitivity (>10,000) of MRI signal collected from 13C-labelled substrates that can be injected into living systems, allowing in-vivo metabolism for the first time to be observed in real-time using imaging.
| Study group | Role | What they receive |
|---|---|---|
| Prostate Cancer | Experimental | Patients with biopsy-proven prostate cancer will be recruited for an additional Hyperpolarised MRI scan prior to any treatment Receives: Diagnostic Test: Hyperpolarised MRI |
| Renal Cancer | Experimental | Patients with biopsy-proven renal cell carcinoma will be recruited for an additional Hyperpolarised MRI scan prior to any treatment Receives: Diagnostic Test: Hyperpolarised MRI |
| Breast Cancer | Experimental | Patients with biopsy-proven breast cancer will be recruited for an additional Hyperpolarised MRI scan prior to any treatment Receives: Diagnostic Test: Hyperpolarised MRI |
| Lymphoma | Experimental | Patients with biopsy-proven lymphoma will be recruited for an additional Hyperpolarised MRI scan prior to any treatment Receives: Diagnostic Test: Hyperpolarised MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 years
Secondary outcomes (3)
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.
Measured: 3 years
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
Measured: 3 years
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.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2018
- Study start1 Jul 2017
- Primary completion30 Jun 2020 (estimated)
- Study completion30 Jun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by University College, LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Collaborators
- Cancer Research UK
- Responsible party
- Principal investigator, Shonit Punwani, University College, London
- Investigators
- Dr Shonit Punwani, Principal investigator, University College, London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03687645
- Sponsor's protocol ID
- 205839
- Status last verified
- Sep 2018
- First submitted
- 11 Sep 2018
- Last updated
- 27 Sep 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 13C- Pyruvate DNP Hyperpolarised Magnetic Resonance Imaging Metabolic Assessment of Disease
- ClinicalTrials.gov ID
- NCT03687645
- Acronym / sponsor ID
- 205839
- Conditions
- Cancer, Cardiovascular Diseases
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Collaborators
- Cancer Research UK
- Study start
- 1 Jul 2017 (actual)
- Primary completion
- 30 Jun 2020 (estimated)
- Study completion
- 30 Jun 2020 (estimated)
- First posted
- 27 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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;
- 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.
- MRI Safety
- 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).
- 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.
- 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.
- 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
- Unexpected Findings: Any unexpected findings in participants with known cancer (e.g. unknown metastatic disease) will be directly communicated to the clinical team.
- 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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Prostate Cancer | Experimental | Diagnostic Test: Hyperpolarised MRIPatients with biopsy-proven prostate cancer will be recruited for an additional Hyperpolarised MRI scan prior to any treatment |
| Renal Cancer | Experimental | Diagnostic Test: Hyperpolarised MRIPatients with biopsy-proven renal cell carcinoma will be recruited for an additional Hyperpolarised MRI scan prior to any treatment |
| Breast Cancer | Experimental | Diagnostic Test: Hyperpolarised MRIPatients with biopsy-proven breast cancer will be recruited for an additional Hyperpolarised MRI scan prior to any treatment |
| Lymphoma | Experimental | Diagnostic Test: Hyperpolarised MRIPatients with biopsy-proven lymphoma will be recruited for an additional Hyperpolarised MRI scan prior to any treatment |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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).
Key exclusion criteria (5 listed)
- Contraindication to MRI (e.g cardiac pacemaker)
- Contraindication to MR contrast agents
- Pregnancy
- Breast Feeding
- Deranged renal function (eGFR<30) -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hyperpolarised MRIHyperpolarized (HP) 13C MR is an advanced imaging technique that allows monitoring of dynamic metabolic processes non-invasively. Hyperpolarisation is a process that provides dramatic gains in sensitivity (>10,000) of MRI signal collected from 13C-labelled substrates that can be injected into living systems, allowing in-vivo metabolism for the first time to be observed in real-time using imaging. | Diagnostic test | Breast Cancer, Lymphoma, Prostate Cancer, Renal Cancer |
Primary outcome
Pyruvate to Lactate conversion following the injection of Hyperpolarised 13C- Pyruvate
Time frame: 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
3 secondary outcomes
Pyruvate to Lactate conversion as an imaging biomarker
Time frame: 3 years
Correlation of Hyperpolarised 13C- Pyruvate MRI with genetic markers
Time frame: 3 years
Hyperpolarised 13C MRI as an imaging biomarker to assess response
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr Shonit Punwani principal investigator
University College, London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hyperpolarised MRI in people with Cancer and Cardiovascular Diseases, run by University College, London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dr Shonit Punwani (00442035495663 ext. 5663, shonit.punwani@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pyruvate to Lactate conversion following the injection of Hyperpolarised 13C- Pyruvate (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Sep 2018.