About this trial
Approximately 50% of cancer patients with solid tumours will be treated with radiotherapy. A significant proportion (\>25%) of patients have hypoxic tumours which respond poorly to radiotherapy. Hypoxic tumours have a poor prognosis. This can be improved with treatment intensification. Treatment intensification can be modification with CON (breathing O2-enriched air + oral administration of nicotinamide), chemoradiosensitisation, radiation dose-escalation or additional systemic treatments, significantly improving response of the tumours to radiotherapy. However, there are currently no clinically approved biomarkers to identify hypoxic tumours. Our group has developed and validated gene-expression signature-based biomarkers that identify patients with hypoxic bladder, head and neck , prostate, sarcoma and lung cancers. The bladder cancer gene-expression hypoxia signature has been shown to predict benefit from hypoxia modification using RNA from archived tumour tissue. The main purpose of this study is to demonstrate in at least two cancer types that the hypoxia biomarker predicts benefit from hypoxia modification in real-time.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Older than age 18 years.
Patients having radiotherapy at the Christie NHS Foundation Trust suitable for imaging on an MRI scanner.
Able to give informed consent.
Older than age 18 years.
Disqualifiers
Any contraindications to MRI identified after MRI safety screening including completion of an MRI Safety Screening Form.
Unable to tolerate MRI scans.
Pregnancy.
Any contraindications to MRI identified after MRI safety screening including completion of an MRI Safety Screening Form.
Trial population
Patient recruitment will be via the disease site clinics .
Trial design
Case-control
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Primary
To have collected the FFPE tumour blocks and generate the gene signature.
Secondary outcomes
Secondary Outcome Measure
To have collected a total of at least 4 different patient blood samples which have corresponding MRI scans from each participant in this study undergoing imaging or treatment. To have developed and optimised MR sequences, which can be used across Manchester and Lancashire in at least two tumour sites.
Sponsors and contacts
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