MRINCT02988531
Validation of PET-MRI for Cardiovascular Disease
A study testing PET/MR scan in people with MRI and PET Scan, run by University of Edinburgh at 1 site in United Kingdom.
Trial summary
To determine whether PET-MRI can obtain comparable images to PET-CT in those with coronary artery disease. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- MRI, PET Scan, Positron-Emission Tomography
- What is being tested?
- PET/MR scan
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 9 Feb 2017to 7 Dec 2017
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing thoracic PET-CT scans (this can include NHS and patients enrolled in other research studies)
- Aged over 50 years old. No upper age limit
- Provision of informed consent prior to any study specific procedures
Who cannot join
- Inability or unwilling to give informed consent.
- Major intercurrent illness with life-expectancy <2 years.
- Contra-indication to Magnetic resonance imaging.
- Permanent or persistent atrial fibrillation.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University of Edinburgh
Edinburgh, Lothian, EH16 4SB
About this study
To determine whether PET-MRI can obtain comparable images to PET-CT in those with coronary artery disease.
Read the detailed description
Positron emission tomography (PET) is method of non-invasively imaging a metabolic process. It has been used in clinical medicine for many years with its primary use in identifying areas of increased metabolic activity as possible cancers. It involves the use of a radionuclide (or radiotracer) labelled to a chemical involved in a certain metabolic process. In order for the PET signal from the radiotracer to be detected by the scanner the radionuclide emits a small dose of ionizing radiation. Examples of commonly used radionuclides include 18FDG and 18 Sodium Fluoride (18NaF). In order to locate where exactly these areas of abnormal or increased metabolic activity were, Computerised Tomography (CT) has traditionally been used for anatomical correlation.
Until recently PET-CT has largely been confined for use in oncology. More recently however PET-CT has been utilized to detect vulnerable plaques in those with coronary artery disease. In coronary artery disease 18F-fluoride acts as a marker of novel calcification activity within the plaque. Similar to other conditions, calcification in coronary atheroma occurs as a healing response to intense necrotic inflammation, making 18F- fluoride a useful marker of high-risk atherosclerotic plaque. This has been demonstrated in those with stable angina as well as localizing the culprit plaque in those with myocardial infarction in 90% of cases.
Magnetic resonance imaging is being increasingly adopted in cardiovascular imaging and holds particular attraction due to its ability to provide information about soft tissue structures both with and without contrast agents, as well as its safety due to absence of exposure to ionising radiation and rapid imaging speed, which is useful in a moving organ like the heart.
PET-MR works differently to PET-CT. PET relies on the annihilation of protons with electrons, generating 511 keV photons, which are absorbed in bodily tissues differently depending on their electron density (e.g. heart denser than lungs). Because of this PET images can appear brighter or darker in different tissues. To account for this, a technique of attenuation correction is employed. This is usually in the form of what is called a transmission scan (low intensity CT scan) which grades tissue density and corrects the PET signal accordingly. Given MRI measures proton density and not electron density different attenuation correction techniques are needed. It has not yet been established how best to do this despite multiple efforts using differing techniques.
Previous single centre studies have demonstrated the feasibility of MRI-PET. The technique's translation to clinical practice has been limited due to the global lack of reliable attenuation correction methods. During his recent Clinical Research Imaging Fellowship in New York, co-investigator (Dr Dweck) developed a novel free breathing method of attenuation correction in a combined PET-MR scanner that reduced scanning time and improved efficiency and has shown immense promise. In Edinburgh a similar combined PET-MR scanner (mMR, Siemens, Erlangen, Germany) has been installed, but have not yet replicated or validated this technique. If the investigators can demonstrate and apply a method of attenuation correction that is acceptable and shows good comparability of MRI-PET to PET-CT images they may be able to use this imaging method as an alternative to PET-CT.
Benefits which may translate clinically include superior soft tissue characterisation and significantly reduced radiation dosages. The technique could be applied across a range of medical conditions in addition to cardiovascular disease and oncology.
The investigators are hopeful to establish a suitable attenuation correction method so that PET-MR can match or even supersede PET-CT as an imaging technique providing accurate biological, anatomical and functional information in those with cardiovascular disease with low radiation doses.
- Conditions
- MRI, PET Scan, Positron-Emission Tomography, Cardiovascular Disease, Coronary Artery Disease, Magnetic Resonance Imaging
- Being tested
- PET/MR scan
- Keywords
- PET, MRI, Attenuation, Correction, Cardiovascular, coronary, disease
- Medical subject headings
- Cardiovascular Diseases, Coronary Artery Disease, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PET/MR scanOther
Patients to undergo PET/MR scanning after PET/CT scan. Patients will have had an injection of 18F Sodium Fluoride for their PET/CT therefore will not need another dose of radiotracer prior to their PET/MR scan.
| Study group | Role | What they receive |
|---|---|---|
| PET/MR | Experimental | Participants to have PET/MR scan Receives: Other: PET/MR scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
The standard uptake values (SUV's) of volumes of interest (VOI's) on corresponding PET-CT and PET-MR images will be evaluated by expert. The distribution of PET positive VOI's will be compared using a cut-off of 1.6 for tissue to background ratio (TBR).
Measured: 7 months
Secondary outcomes (1)
Standard breath-held MR-based attenuation correction will be compared to a novel free-breathing approach. Impact on PET image artifacts and the interpretation of vascular uptake will be evaluated semi-quantitatively by expert readers.
Measured: 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2016 (estimated)
- Study start9 Feb 2017
- Primary completion7 Dec 2017
- Study completion7 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for MRIStudies of the same condition, open and under way.
- More trials run by University of EdinburghThe 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Edinburgh
- Sponsor type
- University, hospital or other
- Collaborators
- British Heart Foundation
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02988531
- Sponsor's protocol ID
- AC16105
- Status last verified
- Oct 2017
- First submitted
- 23 Sep 2016
- Last updated
- 21 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plans to share patient specific data
Publications
Dweck MR, Chow MW, Joshi NV, Williams MC, Jones C, Fletcher AM, Richardson H, White A, McKillop G, van Beek EJ, Boon NA, Rudd JH, Newby DE. Coronary arterial 18F-sodium fluoride uptake: a novel marker of plaque biology. J Am Coll Cardiol. 2012 Apr 24;59(17):1539-48. doi: 10.1016/j.jacc.2011.12.037.
PubMed 22516444Dweck MR, Khaw HJ, Sng GK, Luo EL, Baird A, Williams MC, Makiello P, Mirsadraee S, Joshi NV, van Beek EJ, Boon NA, Rudd JH, Newby DE. Aortic stenosis, atherosclerosis, and skeletal bone: is there a common link with calcification and inflammation? Eur Heart J. 2013 Jun;34(21):1567-74. doi: 10.1093/eurheartj/eht034. Epub 2013 Feb 7.
PubMed 23391586Joshi NV, Vesey AT, Williams MC, Shah AS, Calvert PA, Craighead FH, Yeoh SE, Wallace W, Salter D, Fletcher AM, van Beek EJ, Flapan AD, Uren NG, Behan MW, Cruden NL, Mills NL, Fox KA, Rudd JH, Dweck MR, Newby DE. 18F-fluoride positron emission tomography for identification of ruptured and high-risk coronary atherosclerotic plaques: a prospective clinical trial. Lancet. 2014 Feb 22;383(9918):705-13. doi: 10.1016/S0140-6736(13)61754-7. Epub 2013 Nov 11.
PubMed 24224999
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of PET-MRI for Cardiovascular Disease
- ClinicalTrials.gov ID
- NCT02988531
- Acronym / sponsor ID
- AC16105
- Conditions
- MRI, PET Scan, Positron-Emission Tomography, Cardiovascular Disease, Coronary Artery Disease, Magnetic Resonance Imaging
- Keywords
- PET, MRI, Attenuation, Correction, Cardiovascular, coronary, disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of EdinburghUniversity, hospital or other
- Collaborators
- British Heart Foundation
- Study start
- 9 Feb 2017 (actual)
- Primary completion
- 7 Dec 2017 (actual)
- Study completion
- 7 Dec 2017 (actual)
- First posted
- 9 Dec 2016 (estimated)
- 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.
To determine whether PET-MRI can obtain comparable images to PET-CT in those with coronary artery disease.
Detailed description
Positron emission tomography (PET) is method of non-invasively imaging a metabolic process. It has been used in clinical medicine for many years with its primary use in identifying areas of increased metabolic activity as possible cancers. It involves the use of a radionuclide (or radiotracer) labelled to a chemical involved in a certain metabolic process. In order for the PET signal from the radiotracer to be detected by the scanner the radionuclide emits a small dose of ionizing radiation. Examples of commonly used radionuclides include 18FDG and 18 Sodium Fluoride (18NaF). In order to locate where exactly these areas of abnormal or increased metabolic activity were, Computerised Tomography (CT) has traditionally been used for anatomical correlation.
Until recently PET-CT has largely been confined for use in oncology. More recently however PET-CT has been utilized to detect vulnerable plaques in those with coronary artery disease. In coronary artery disease 18F-fluoride acts as a marker of novel calcification activity within the plaque. Similar to other conditions, calcification in coronary atheroma occurs as a healing response to intense necrotic inflammation, making 18F- fluoride a useful marker of high-risk atherosclerotic plaque. This has been demonstrated in those with stable angina as well as localizing the culprit plaque in those with myocardial infarction in 90% of cases.
Magnetic resonance imaging is being increasingly adopted in cardiovascular imaging and holds particular attraction due to its ability to provide information about soft tissue structures both with and without contrast agents, as well as its safety due to absence of exposure to ionising radiation and rapid imaging speed, which is useful in a moving organ like the heart.
PET-MR works differently to PET-CT. PET relies on the annihilation of protons with electrons, generating 511 keV photons, which are absorbed in bodily tissues differently depending on their electron density (e.g. heart denser than lungs). Because of this PET images can appear brighter or darker in different tissues. To account for this, a technique of attenuation correction is employed. This is usually in the form of what is called a transmission scan (low intensity CT scan) which grades tissue density and corrects the PET signal accordingly. Given MRI measures proton density and not electron density different attenuation correction techniques are needed. It has not yet been established how best to do this despite multiple efforts using differing techniques.
Previous single centre studies have demonstrated the feasibility of MRI-PET. The technique's translation to clinical practice has been limited due to the global lack of reliable attenuation correction methods. During his recent Clinical Research Imaging Fellowship in New York, co-investigator (Dr Dweck) developed a novel free breathing method of attenuation correction in a combined PET-MR scanner that reduced scanning time and improved efficiency and has shown immense promise. In Edinburgh a similar combined PET-MR scanner (mMR, Siemens, Erlangen, Germany) has been installed, but have not yet replicated or validated this technique. If the investigators can demonstrate and apply a method of attenuation correction that is acceptable and shows good comparability of MRI-PET to PET-CT images they may be able to use this imaging method as an alternative to PET-CT.
Benefits which may translate clinically include superior soft tissue characterisation and significantly reduced radiation dosages. The technique could be applied across a range of medical conditions in addition to cardiovascular disease and oncology.
The investigators are hopeful to establish a suitable attenuation correction method so that PET-MR can match or even supersede PET-CT as an imaging technique providing accurate biological, anatomical and functional information in those with cardiovascular disease with low radiation doses.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PET/MR | Experimental | Other: PET/MR scanParticipants to have PET/MR scan |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients undergoing thoracic PET-CT scans (this can include NHS and patients enrolled in other research studies)
- Aged over 50 years old. No upper age limit
- Provision of informed consent prior to any study specific procedures
Key exclusion criteria (4 listed)
- Inability or unwilling to give informed consent.
- Major intercurrent illness with life-expectancy <2 years.
- Contra-indication to Magnetic resonance imaging.
- Permanent or persistent atrial fibrillation.
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 |
|---|---|---|
| PET/MR scanPatients to undergo PET/MR scanning after PET/CT scan. Patients will have had an injection of 18F Sodium Fluoride for their PET/CT therefore will not need another dose of radiotracer prior to their PET/MR scan. | Other | PET/MR |
Primary outcome
The standard uptake values (SUV's) of volumes of interest (VOI's) on corresponding PET-CT and PET-MR images will be evaluated by expert. The distribution of PET positive VOI's will be compared using a cut-off of 1.6 for tissue to background ratio (TBR).
Time frame: 7 months
1 secondary outcome
Standard breath-held MR-based attenuation correction will be compared to a novel free-breathing approach. Impact on PET image artifacts and the interpretation of vascular uptake will be evaluated semi-quantitatively by expert readers.
Time frame: 7 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2024.
- Background: PubMed 22516444Dweck MR, Chow MW, Joshi NV, Williams MC, Jones C, Fletcher AM, Richardson H, White A, McKillop G, van Beek EJ, Boon NA, Rudd JH, Newby DE. Coronary arterial 18F-sodium fluoride uptake: a novel marker of plaque biology. J Am Coll Cardiol. 2012 Apr 24;59(17):1539-48. doi: 10.1016/j.jacc.2011.12.037.
- Background: PubMed 23391586Dweck MR, Khaw HJ, Sng GK, Luo EL, Baird A, Williams MC, Makiello P, Mirsadraee S, Joshi NV, van Beek EJ, Boon NA, Rudd JH, Newby DE. Aortic stenosis, atherosclerosis, and skeletal bone: is there a common link with calcification and inflammation? Eur Heart J. 2013 Jun;34(21):1567-74. doi: 10.1093/eurheartj/eht034. Epub 2013 Feb 7.
- Background: PubMed 24224999Joshi NV, Vesey AT, Williams MC, Shah AS, Calvert PA, Craighead FH, Yeoh SE, Wallace W, Salter D, Fletcher AM, van Beek EJ, Flapan AD, Uren NG, Behan MW, Cruden NL, Mills NL, Fox KA, Rudd JH, Dweck MR, Newby DE. 18F-fluoride positron emission tomography for identification of ruptured and high-risk coronary atherosclerotic plaques: a prospective clinical trial. Lancet. 2014 Feb 22;383(9918):705-13. doi: 10.1016/S0140-6736(13)61754-7. Epub 2013 Nov 11.
- Individual participant dataSharing planned: No. No plans to share patient specific data
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PET/MR scan in people with MRI and PET Scan, run by University of Edinburgh 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 3 inclusion and 4 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: finished, as of the sponsor's last update on 21 May 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The standard uptake values (SUV's) of volumes of interest (VOI's) on corresponding PET-CT and PET-MR images will be evaluated by expert. The distribution of PET positive VOI's will be compared using a cut-off of 1.6 for tissue to background ratio (TBR). (time frame: 7 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02988531, which also lists 3 linked publications.
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 21 May 2024.