Selecting Hypoxic Tumours for Treatment Modification

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of Manchester

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 volunteers

Qualifiers

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

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

30 Participants
are grouped into 3 trial groups
Group A: Bladder
Group B: Prostate
Group C: Cervix

Trial outcomes

Primary outcomes

1

Primary

To have collected the FFPE tumour blocks and generate the gene signature.

Time frame
Through to study completion, until May 2028

Secondary outcomes

1

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.

Time frame
end of the study in May 2028

Other outcomes

Sponsors and contacts

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