Evaluation of New Magnetic Resonance Techniques

NCT05118555 | Recruiting

• 1 other identifier: CCR5359
• Study Type: observational
• Target: 2,850
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Magnetic Resonance Imaging

Outcome Measures

Primary Outcomes (5)

• 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.

  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)

  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)

  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.

  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.)

  10 years

Study Arms (3)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Royal Marsden Hospital patients and normal volunteers

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Royal Marsden NHS Foundation Trust: lead

Study Sites (1)

The Royal Marsden NHS Foundation Trust

Sutton, Surrey, SM2 5PT, United Kingdom

RECRUITING

Related Publications (1)

• 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.

  PMID: 41299300 DERIVED

Study Officials

• Dow-Mu Koh, MD,FRCP,FRCR

  Royal Marsden NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bertha Adjei

CONTACT

0208 661 3728; Bertha.Adjei4@rmh.nhs.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 18, 2021
• First Posted: November 12, 2021
• Study Start: April 21, 2021
• Primary Completion (Estimated): January 1, 2031
• Study Completion (Estimated): January 1, 2031
• Last Updated: November 29, 2021

Record last verified: 2021-11

Locations

GB (1)