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MR-BIO: A Study to Evaluate Changes in MR Imaging and Biological Parameters

MR-BIO: A Study to Evaluate Changes in MR Imaging and Biological Parameters

Recruiting
18 years and older
All
Phase N/A

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Overview

The MR BIO study aims to understand the changes in the tumour and normal tissues during a course of radiotherapy. This is accomplished by studying the MR images taken during each treatment session on the MR Linear accelerator (MR Linac). The overarching hypothesis is that changes in MR imaging and biological parameters from blood, tissue, or urine biomarkers can be measured during radiotherapy and associated with clinical outcome.

The MR Linac is a new radiotherapy machine with an on board MR scanner. This enables us to take images with high resolution and target the tumours more precisely and also reduce the dose to normal tissues. All patients undergoing treatment in the MR Linac at the Christie hospital will be considered for enrolment regardless of tumour site being treated.

The study participants will receive the standard of care treatment for their disease condition. In addition, they will be requested to give weekly blood and urine samples during the course of radiotherapy and at first follow up. On completion of radiotherapy treatment, the participants will continue to be on standard of care follow up protocol with the treating oncologist.

A small cohort of ten healthy volunteers will also be recruited to the study to develop and select some of the MR sequences only; they will not provide blood or urine samples. The healthy volunteers will be scanned for no more than one hour per session for a maximum of two sessions in total. These optimised sequences can then be used in the patient cohort.

Eligibility

Inclusion Criteria:

        Be willing and able to provide written consent. Over 18 years of age. Undergo and satisfy
        MRI Safety Screening Patient volunteers must be under the care of a clinical oncologist at
        The Christie NHS Foundation Trust and be planned to receive radiotherapy to the target site
        to be imaged.
        Patient volunteers must be able to give blood and/or urine sample as required through the
        treatment period.
        Non-patient (healthy) volunteers must have no known or suspected significant medical
        condition.
        Exclusion Criteria:
        The following apply to both patients and healthy volunteers:
        Any conditions that would be a contra-indication to MRI including:
          -  Failure to satisfy MRI Safety Screening Form
          -  Implanted pacemakers and/or pacing wires
          -  Cochlear implants
          -  Programmable hydrocephalus shunts
          -  Ferromagnetic implants
          -  Unable to tolerate MR scans
          -  Known HIV or active HepB or C
          -  Pregnancy Healthy volunteers must not be a member of the study team.

Study details
    Cancer

NCT04903236

University of Manchester

27 January 2024

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FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

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The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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