Magnetic Resonance ImagingNCT05118555
Evaluation of New Magnetic Resonance Techniques
An observational study of Magnetic Resonance Imaging, run by Royal Marsden NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
The aim of this research protocol is to undertake evaluation of new and emerging MR techniques in patients and healthy volunteers following software or hardware upgrades, as well as for newly developed MR techniques; to establish their feasibility, image quality and/or measurement repeatability/ reproducibility. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Magnetic Resonance Imaging
- How many people
- 2,850 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 21 Apr 2021to Jan 2031
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Royal Marsden Hospital patients and normal volunteers
Who may be able to join
- Type 1: Patients undergoing a routine clinical MR examination using established MR techniques to which an additional new sequence is added for evaluation, who give verbal consent for additional data to be acquired for evaluation of a new MR technique.
- Type 2: Patients who voluntarily agree to participate in the study by giving written informed consent.
- Type 3: Normal volunteers who voluntarily agree to participate in the study by giving written informed consent.
Who cannot join
- Standard MR Exclusion criteria apply to all MR examinations, as documented in the MRI Local Rules.
- Patients or volunteers who are unwilling to undergo an additional MR examination, for example due to claustrophobia, will be excluded from the study.
- Normal volunteers who do not have an NHS number or who are not registered with a GP will be excluded.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
The Royal Marsden NHS Foundation Trust
Sutton, Surrey, SM2 5PT
Bertha Adjei, 0208 661 3728, Bertha.Adjei4@rmh.nhs.uk
About this study
The aim of this research protocol is to undertake evaluation of new and emerging MR techniques in patients and healthy volunteers following software or hardware upgrades, as well as for newly developed MR techniques; to establish their feasibility, image quality and/or measurement repeatability/ reproducibility.
Read the detailed description
This study is a 'master protocol', analogous to an umbrella trial design, that seeks to evaluate multiple new MR techniques. As such, the study is designed to identify promising techniques that merit further investigation. Following successful evaluation as part of this study, new MR techniques will either be adopted into clinical practice or developed further in a larger research study.
Type 1) The new measurements are added to an existing patient examination, to allow evaluation of the benefits of the new approach in comparison with standard procedures, in the pathology of interest. This frequently is required during development of a new approach, when measurements indicate shortcomings that can be corrected by modification of the sequence, or in assessing a new software release from the manufacturer, which provides a range of new or improved facilities, that must be assessed in relation to our established approach. In this case patients undergoing established procedures or protocols will be measured with additional sequences provided that the additional examinations do not add more than 15 minutes to the total examination, that exposure is below or within the first level controlled MR safety mode, and is not indicated to be likely to cause any adverse effects. No additional intra-venous contrast agents will be administered (patients will receive intra-venous contrast agent if indicated as part of their routine examination). These measurements will be performed with verbal consent from the patient, which will be documented in the patient's Electronic Patient Record (EPR).
Type 2) The measurements for evaluation or development of a new technique (usually in a research setting) require a complete measurement or series of measurements to evaluate the technique in appropriate pathology, often during the course of treatment. These measurements will typically last for 30-60 minutes, the duration of standard MR examinations. In exceptional circumstances these measurements will last up to 90 minutes. Measurements will be conducted with the consent of the clinician responsible for the patient, which will be documented in the patient's Electronic Patient Record (EPR). Measurements will be performed with written informed consent from the patient. As this is a dedicated session for the purpose of evaluating the new technique, this will require informed consent with a clear indication of any potential adverse effects in the patient information sheet, even if such measurement is performed during a routine clinically indicated or research examination. No intra-venous contrast agents will be administered as a part of this protocol.
Type 3) The measurements for evaluation or development of a new technique require measurements in normal volunteers to establish the correct operation and value of the technique, and in some cases to assess measurement repeatability or reproducibility. These measurements will typically last for 30-60 minutes, the duration of standard MR examinations. In exceptional circumstances these measurements will last up to 90 minutes. Measurements will be performed with written informed consent from the volunteer. Any potential adverse effects will be clearly indicated in the volunteer information sheet. No intra-venous contrast agents will be administered.
- Conditions
- Magnetic Resonance Imaging
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Type 1 | Patients scheduled to undergo a routine clinical MR examination of the relevant anatomical regions and/or disease type will be identified from MRI department schedules. The new MR technique will be used to acquire additional data in patients undergoing a routine MR examination. The routine MR examination will be conducted according to the standard protocol. | |
| Type 2 | Patients with the relevant disease type and no contraindications to MRI will be identified by delegated radiologists in clinics. An additional MR examination will be scheduled; this examination is in addition to any examinations that the patient may undergo as part of their clinical care. The MR examination will be conducted using the new MR technique; standard MR techniques may also be used for comparison. | |
| Type 3 | Normal volunteers who are members of staff or students at RMH/ICR will be invited to participate using a mailing list. Exceptionally employees of other NHS Trusts and Academic Institutions will be allowed to participate if they are in collaboration with RMH/ICR. An MR examination will be conducted using the new MR technique; standard MR techniques may also be used for comparison. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of a new MR technique
Assessment of feasibility is required at the earliest stages of development of a new MR technique. We will assess whether a new MR technique can be implemented on our MRI scanners with at least 60% success in achieving the desired measurement. 'Success' will be defined as: i. Acceptable quality of the MR image (or other MR data), assessed by a consultant radiologist or MR physicist, depending in the technique being investigated. ii. Acquisition time up to 15 minutes per sequence.
Measured: 10 years
Qualitative assessment of a new MR technique (e.g. image quality)
mage quality will be assessed using a 5-point Likert scale (1 = unacceptable/non diagnostic images, 2 = diagnostic images with some artefacts affecting interpretation, 3 = moderate quality images, 4 = good, 5 = excellent image quality with no artefacts)
Measured: 10 years
Objective comparison of a new MR technique with a current MR technique
(1 = unacceptable/non diagnostic images, 2 = diagnostic images with some artefacts affecting interpretation, 3 = moderate quality images, 4 = good, 5 = excellent image quality with no artefacts)
Measured: 10 years
Assessment of repeatability or reproducibility of a quantitative metric using a new MR technique
Repeatability or reproducibility will be assessed using two measurements separated by a short time interval using the same MRI scanner (repeatability) or a different MRI scanner (reproducibility). Bland-Altman plots will be used to assess repeatability / reproducibility and 95% limits of agreement (LoA) will be estimated.
Measured: 10 years
Assessment of a new MR technique in pre- and post-treatment measurements
Quantitative measurements from a new MR technique will be assessed in pre- and post treatment measurements, in order to assess the dynamic range of post-treatment changes relative to the repeatability of the measurement. These data will be used to assess whether further clinical studies are warranted for assessment of the new technique as a potential imaging biomarker. (The treatment is not part of this study, and will be standard-of-care. The timepoints will be defined relative to the standard-of-care pathway and will be fixed for all patients assessed per disease/MR technique.)
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2021
- Study start21 Apr 2021
- Primary completionJan 2031 (estimated)
- Study completionJan 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Magnetic Resonance ImagingStudies of the same condition, open and under way.
- More trials run by Royal Marsden NHS Foundation TrustThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,850 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Royal Marsden NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dow-Mu Koh, MD,FRCP,FRCR, Principal investigator, Royal Marsden NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05118555
- Sponsor's protocol ID
- CCR5359
- Status last verified
- Nov 2021
- First submitted
- 18 Oct 2021
- Last updated
- 29 Nov 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Rata M, Castagnoli F, Shur J, Evans E, Hopkinson G, Benkert T, Weiland E, Koh DM, Winfield JM. Qualitative and quantitative assessment of accelerated liver diffusion-weighted imaging using deep-learning reconstruction in oncologic patients. BMC Med Imaging. 2025 Nov 26;25(1):491. doi: 10.1186/s12880-025-02030-3.
PubMed 41299300
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of New Magnetic Resonance Techniques
- ClinicalTrials.gov ID
- NCT05118555
- Acronym / sponsor ID
- CCR5359
- Conditions
- Magnetic Resonance Imaging
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,850 participants (estimated)
- Lead sponsor
- Royal Marsden NHS Foundation TrustUniversity, hospital or other
- Study start
- 21 Apr 2021 (actual)
- Primary completion
- Jan 2031 (estimated)
- Study completion
- Jan 2031 (estimated)
- First posted
- 12 Nov 2021 (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.
The aim of this research protocol is to undertake evaluation of new and emerging MR techniques in patients and healthy volunteers following software or hardware upgrades, as well as for newly developed MR techniques; to establish their feasibility, image quality and/or measurement repeatability/ reproducibility.
Detailed description
This study is a 'master protocol', analogous to an umbrella trial design, that seeks to evaluate multiple new MR techniques. As such, the study is designed to identify promising techniques that merit further investigation. Following successful evaluation as part of this study, new MR techniques will either be adopted into clinical practice or developed further in a larger research study.
Type 1) The new measurements are added to an existing patient examination, to allow evaluation of the benefits of the new approach in comparison with standard procedures, in the pathology of interest. This frequently is required during development of a new approach, when measurements indicate shortcomings that can be corrected by modification of the sequence, or in assessing a new software release from the manufacturer, which provides a range of new or improved facilities, that must be assessed in relation to our established approach. In this case patients undergoing established procedures or protocols will be measured with additional sequences provided that the additional examinations do not add more than 15 minutes to the total examination, that exposure is below or within the first level controlled MR safety mode, and is not indicated to be likely to cause any adverse effects. No additional intra-venous contrast agents will be administered (patients will receive intra-venous contrast agent if indicated as part of their routine examination). These measurements will be performed with verbal consent from the patient, which will be documented in the patient's Electronic Patient Record (EPR).
Type 2) The measurements for evaluation or development of a new technique (usually in a research setting) require a complete measurement or series of measurements to evaluate the technique in appropriate pathology, often during the course of treatment. These measurements will typically last for 30-60 minutes, the duration of standard MR examinations. In exceptional circumstances these measurements will last up to 90 minutes. Measurements will be conducted with the consent of the clinician responsible for the patient, which will be documented in the patient's Electronic Patient Record (EPR). Measurements will be performed with written informed consent from the patient. As this is a dedicated session for the purpose of evaluating the new technique, this will require informed consent with a clear indication of any potential adverse effects in the patient information sheet, even if such measurement is performed during a routine clinically indicated or research examination. No intra-venous contrast agents will be administered as a part of this protocol.
Type 3) The measurements for evaluation or development of a new technique require measurements in normal volunteers to establish the correct operation and value of the technique, and in some cases to assess measurement repeatability or reproducibility. These measurements will typically last for 30-60 minutes, the duration of standard MR examinations. In exceptional circumstances these measurements will last up to 90 minutes. Measurements will be performed with written informed consent from the volunteer. Any potential adverse effects will be clearly indicated in the volunteer information sheet. No intra-venous contrast agents will be administered.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Type 1 | – | –Patients scheduled to undergo a routine clinical MR examination of the relevant anatomical regions and/or disease type will be identified from MRI department schedules. The new MR technique will be used to acquire additional data in patients undergoing a routine MR examination. The routine MR examination will be conducted according to the standard protocol. |
| Type 2 | – | –Patients with the relevant disease type and no contraindications to MRI will be identified by delegated radiologists in clinics. An additional MR examination will be scheduled; this examination is in addition to any examinations that the patient may undergo as part of their clinical care. The MR examination will be conducted using the new MR technique; standard MR techniques may also be used for comparison. |
| Type 3 | – | –Normal volunteers who are members of staff or students at RMH/ICR will be invited to participate using a mailing list. Exceptionally employees of other NHS Trusts and Academic Institutions will be allowed to participate if they are in collaboration with RMH/ICR. An MR examination will be conducted using the new MR technique; standard MR techniques may also be used for comparison. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Royal Marsden Hospital patients and normal volunteers
Key inclusion criteria (3 listed)
- Type 1: Patients undergoing a routine clinical MR examination using established MR techniques to which an additional new sequence is added for evaluation, who give verbal consent for additional data to be acquired for evaluation of a new MR technique.
- Type 2: Patients who voluntarily agree to participate in the study by giving written informed consent.
- Type 3: Normal volunteers who voluntarily agree to participate in the study by giving written informed consent.
Key exclusion criteria (3 listed)
- Standard MR Exclusion criteria apply to all MR examinations, as documented in the MRI Local Rules.
- Patients or volunteers who are unwilling to undergo an additional MR examination, for example due to claustrophobia, will be excluded from the study.
- Normal volunteers who do not have an NHS number or who are not registered with a GP will be excluded.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Feasibility of a new MR technique
Time frame: 10 years
Assessment of feasibility is required at the earliest stages of development of a new MR technique. We will assess whether a new MR technique can be implemented on our MRI scanners with at least 60% success in achieving the desired measurement. 'Success' will be defined as: i. Acceptable quality of the MR image (or other MR data), assessed by a consultant radiologist or MR physicist, depending in the technique being investigated. ii. Acquisition time up to 15 minutes per sequence.
Qualitative assessment of a new MR technique (e.g. image quality)
Time frame: 10 years
mage quality will be assessed using a 5-point Likert scale (1 = unacceptable/non diagnostic images, 2 = diagnostic images with some artefacts affecting interpretation, 3 = moderate quality images, 4 = good, 5 = excellent image quality with no artefacts)
Objective comparison of a new MR technique with a current MR technique
Time frame: 10 years
(1 = unacceptable/non diagnostic images, 2 = diagnostic images with some artefacts affecting interpretation, 3 = moderate quality images, 4 = good, 5 = excellent image quality with no artefacts)
Assessment of repeatability or reproducibility of a quantitative metric using a new MR technique
Time frame: 10 years
Repeatability or reproducibility will be assessed using two measurements separated by a short time interval using the same MRI scanner (repeatability) or a different MRI scanner (reproducibility). Bland-Altman plots will be used to assess repeatability / reproducibility and 95% limits of agreement (LoA) will be estimated.
Assessment of a new MR technique in pre- and post-treatment measurements
Time frame: 10 years
Quantitative measurements from a new MR technique will be assessed in pre- and post treatment measurements, in order to assess the dynamic range of post-treatment changes relative to the repeatability of the measurement. These data will be used to assess whether further clinical studies are warranted for assessment of the new technique as a potential imaging biomarker. (The treatment is not part of this study, and will be standard-of-care. The timepoints will be defined relative to the standard-of-care pathway and will be fixed for all patients assessed per disease/MR technique.)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2021.
- Derived from this study: PubMed 41299300Rata M, Castagnoli F, Shur J, Evans E, Hopkinson G, Benkert T, Weiland E, Koh DM, Winfield JM. Qualitative and quantitative assessment of accelerated liver diffusion-weighted imaging using deep-learning reconstruction in oncologic patients. BMC Med Imaging. 2025 Nov 26;25(1):491. doi: 10.1186/s12880-025-02030-3.
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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.
Dow-Mu Koh, MD,FRCP,FRCR principal investigator
Royal Marsden NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Magnetic Resonance Imaging, run by Royal Marsden NHS Foundation Trust 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 3 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: looking for participants now, as of the sponsor's last update on 29 Nov 2021. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bertha Adjei (0208 661 3728, Bertha.Adjei4@rmh.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of a new MR technique (time frame: 10 years). The study lists 5 primary outcomes in all. 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 NCT05118555, which also lists 1 linked publication.
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 29 Nov 2021.