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

ConditionCancer
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of Manchester

About this trial

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 criteria

This trial accepts healthy volunteers

Qualifiers

None

Disqualifiers

Failure to satisfy MRI Safety Screening Form

Implanted pacemakers and/or pacing wires

Cochlear implants

Programmable hydrocephalus shunts

Trial population

The Christie.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

250 Participants
are grouped into 2 trial groups
Group A: Non-patient healthy volunteer
Group B: Patient

Trial outcomes

Primary outcomes

1

Correlation of biomarkers

Analysis of MR images will be performed using in-house protocols based on established mathematical modelling techniques. Pearson correlation analysis will be used to assess relationships between MRI parameters and tissue markers. For oxygen enhanced imaging, two-sample unpaired t-tests will be used to identify changes in tissue oxygen in MR images. Descriptive statistics will be presented using median and 95% confidence intervals (CI) or standard deviation (SD). In addition, Bland-Altman analysis will be performed to calculate bias and 95% limits of agreement between the two measurement techniques.

Time frame
Up to five years

Secondary outcomes

1

Correlation with patient reported toxicity

Association of detected imaging changes with variations in patient-reported toxicity and radiotherapy response at first follow up after radiotherapy.

Time frame
Up to five years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Manchester

Lead sponsor

The Christie NHS Foundation Trust

Collaborator