Clinical trial NCT05118555: Evaluation of New Magnetic Resonance Techniques
Official title: Evaluation of New Magnetic Resonance Techniques
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Magnetic Resonance Imaging
Lead sponsor: Royal Marsden NHS Foundation Trust
Sponsor class: OTHER
First posted: 2021-11-12
Enrollment: 2850
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Royal Marsden Hospital patients and normal volunteers

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.

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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Feasibility of a new MR technique
timeFrame: 10 years
measure: Qualitative assessment of a new MR technique (e.g. image quality)
timeFrame: 10 years
measure: Objective comparison of a new MR technique with a current MR technique
timeFrame: 10 years
measure: Assessment of repeatability or reproducibility of a quantitative metric using a new MR technique
timeFrame: 10 years
measure: Assessment of a new MR technique in pre- and post-treatment measurements
timeFrame: 10 years
Secondary outcomes:
Other outcomes:
Locations:
city: Sutton
country: United Kingdom
facility: The Royal Marsden NHS Foundation Trust
state: Surrey
Study officials:
affiliation: Royal Marsden NHS Foundation Trust
name: Dow-Mu Koh, MD,FRCP,FRCR
role: PRINCIPAL_INVESTIGATOR
References: