The Christie NHS Foundation Trust
Manchester, M20 4BX, United Kingdom
Location status: Recruiting
Location contact
Ananya Choudhury, Professor
PRINCIPAL_INVESTIGATOR
Kimberley Reeves, PhD
CONTACT
Rachel Reed, MSc
CONTACT
NCT Number: NCT04903236
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.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Manchester, M20 4BX, United Kingdom
Location status: Recruiting
Ananya Choudhury, Professor
PRINCIPAL_INVESTIGATOR
Kimberley Reeves, PhD
CONTACT
Rachel Reed, MSc
CONTACT
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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:
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.
Time frame: Up to five years
Association of detected imaging changes with variations in patient-reported toxicity and radiotherapy response at first follow up after radiotherapy.
Contact information is provided by the study sponsor or research team.
Kimberley Reeves, PhD
CONTACT
Rachel Reed, MSc
CONTACT
University of Manchester
Other
Acronym: MR-BIO
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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