Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
2850 participants
OBSERVATIONAL
2021-04-21
2031-01-31
Brief Summary
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Detailed Description
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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
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
No interventions assigned to this group
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.
No interventions assigned to this group
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.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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
* Normal volunteers who do not have an NHS number or who are not registered with a GP will be excluded.
18 Years
ALL
Yes
Sponsors
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Royal Marsden NHS Foundation Trust
OTHER
Responsible Party
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Principal Investigators
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Dow-Mu Koh, MD,FRCP,FRCR
Role: PRINCIPAL_INVESTIGATOR
Royal Marsden NHS Foundation Trust
Locations
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The Royal Marsden NHS Foundation Trust
Sutton, Surrey, United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Bertha Adjei
Role: primary
Other Identifiers
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CCR5359
Identifier Type: -
Identifier Source: org_study_id