Selecting Hypoxic Tumours for Treatment Modification
Recruiting · NCT06787053 · Observational (researchers observe without assigning treatment) · Lead sponsor: University of Manchester
View the official record on ClinicalTrials.gov →What this trial is about
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.
Who can take part
Inclusion criteria
- This will be tumour site dependent.
- Bladder:
- 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.
- Cervix:
- 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.
- Prostate:
- 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.
Exclusion criteria
- This will be tumour site dependent
- Bladder:
- Any contraindications to MRI identified after MRI safety screening including completion of an MRI Safety Screening Form.
- Unable to tolerate MRI scans.
- Pregnancy.
- Cervix:
- Any contraindications to MRI identified after MRI safety screening including completion of an MRI Safety Screening Form.
- Unable to tolerate MRI scans.
- Pregnancy.
- Prostate:
- Any contraindications to MRI identified after MRI safety screening including completion of an MRI Safety Screening Form.
- Unable to tolerate MRI scans
Where it is running
1 location listed.
- The Christie NHS Foundation Trust - Manchester, United Kingdom