CancerMR-BIONCT04903236
MR-BIO: A Study to Evaluate Changes in MR Imaging and Biological Parameters
An observational study of Cancer, run by University of Manchester at 1 site in United Kingdom.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cancer
- How many people
- 250 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 20 Oct 2020to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The Christie.
Who may be able to join
- 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.
Who cannot join
- 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
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Kimberley Reeves, PhD contact
United Kingdom1 site, 1 recruiting
- Recruiting
The Christie NHS Foundation Trust
Manchester, M20 4BX
Rachel Reed, MSc, 01619187029, rachel.reed18@nhs.net
Kimberley Reeves, PhD, kimberley.reeves@manchester.ac.uk
About this study
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.
Read more
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
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Up to five years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2021
- Study start20 Oct 2020
- Primary completion1 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by University of ManchesterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Manchester
- Sponsor type
- University, hospital or other
- Collaborators
- The Christie NHS Foundation Trust
- Responsible party
- Principal investigator, Ananya Choudhury, University of Manchester
- Investigators
- Ananya Choudhury, PhD, FRCR, MRCP, MA, MB BChir,, Principal investigator, The Christie NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04903236
- Sponsor's protocol ID
- NHS001677
- Acronym
- MR-BIO
- Status last verified
- May 2026
- First submitted
- 22 Dec 2020
- Last updated
- 12 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MR-BIO: A Study to Evaluate Changes in MR Imaging and Biological Parameters
- ClinicalTrials.gov ID
- NCT04903236
- Acronym / sponsor ID
- MR-BIO / NHS001677
- Conditions
- Cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- University of ManchesterUniversity, hospital or other
- Collaborators
- The Christie NHS Foundation Trust
- Study start
- 20 Oct 2020 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 26 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The Christie.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (10 listed)
- Failure to satisfy MRI Safety Screening Form
- Implanted pacemakers and/or pacing wires
- Cochlear implants
- Programmable hydrocephalus shunts
- Ferromagnetic implants
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Correlation of biomarkers
Time frame: Up to five years
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.
1 secondary outcome
Correlation with patient reported toxicity
Time frame: Up to five years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kimberley Reeves, PhD contact
Ananya Choudhury, PhD, FRCR, MRCP, MA, MB BChir, principal investigator
The Christie NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer, run by University of Manchester at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rachel Reed, MSc (01619187029, rachel.reed18@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation of biomarkers (time frame: Up to five years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2026.