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

NCT04903236 | Recruiting

• 1 other identifier: NHS001677
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cancer

Outcome Measures

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.

  Up to five years

Secondary Outcomes (1)

• Correlation with patient reported toxicity

  Up to five years

Study Arms (2)

Non-patient healthy volunteer

Undertake MR Imaging to enable development of sequences.

Patient

Provide weekly blood and urine samples during period of radiotherapy as well as additional MR images.

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

The Christie.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Manchester: lead
• The Christie NHS Foundation Trust: collaborator

Study Sites (1)

The Christie NHS Foundation Trust

Manchester, M20 4BX, United Kingdom

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

The biospecimens collected and stored from each patient will include the following; tissue in the form of a diagnostic block in a Formalin Fixed Paraffin Embedded (FFPE) block, whole blood, plasma, and urine (both cell containing and cell depleted).

MeSH Terms

Conditions

Neoplasms

Study Officials

• Ananya Choudhury, PhD, FRCR, MRCP, MA, MB BChir,

  The Christie NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rachel Reed, MSc

CONTACT

01619187029; rachel.reed18@nhs.net

Kimberley Reeves, PhD

CONTACT

kimberley.reeves@manchester.ac.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chair and Honorary Consultant in Clinical Oncology

Study Record Dates

• First Submitted: December 22, 2020
• First Posted: May 26, 2021
• Study Start: October 20, 2020
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: May 12, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)