NCT04903236 MR-BIO: A Study to Evaluate Changes in MR Imaging and Biological Parameters
| NCT ID | NCT04903236 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Manchester |
| Condition | Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 250 participants |
| Start Date | 2020-10-20 |
| Primary Completion | 2026-12-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 250 participants in total. It began in 2020-10-20 with a primary completion date of 2026-12-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Contact & Investigator
Ananya Choudhury, PhD, FRCR, MRCP, MA, MB BChir,
PRINCIPAL INVESTIGATOR
The Christie NHS Foundation Trust
Frequently Asked Questions
Who can join the NCT04903236 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04903236 currently recruiting?
Yes, NCT04903236 is actively recruiting participants. Contact the research team at rachel.reed18@nhs.net for enrollment information.
Where is the NCT04903236 trial being conducted?
This trial is being conducted at Manchester, United Kingdom.
Who is sponsoring the NCT04903236 clinical trial?
NCT04903236 is sponsored by University of Manchester. The principal investigator is Ananya Choudhury, PhD, FRCR, MRCP, MA, MB BChir, at The Christie NHS Foundation Trust. The trial plans to enroll 250 participants.
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