Outcomes and predictors of efficacy of palliative radiotherapy in patients with malignant pleural mesothelioma

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The primary objective of this study is to demonstrate and prospectively quantify the palliative benefit of external beam radiotherapy to symptomatic mass in malignant pleural mesothelioma (MPM) in terms of patient rated benefits. Who is it for? You may be eligible to join this study if you are aged 18 years or above, have been diagnosed with malignant pleural mesothelioma and will undergo palliative radiotherapy. Study details All participants will receive the following scans in addition to their usual care: 2 F18-FDG PET-CT scans, 1 F18-FMISO PET-CT scan and 2 contrast-enhanced thoracic CT scans. The F18-FDG PET scans will require fasting for 6 hrs prior to the scan, a blood glucose level and an oxygen measurement will also be recorded. Prior to each scan a intravenous cannula will be inserted in to your arm and a 10ml blood sample will be collected for analysis of special biomarkers in a lab. The F18-FDG tracer will be injected into the IV cannula and you will be asked to rest for 60 minutes (for tracer uptake) prior to scanning. The scan should take approx 30 minutes to complete. One F18-FDG PET-CT scan will be performed within 2 weeks of the start of radiotherapy and one will be required 6 weeks after radiotherapy. One F18-FMISO PET-CT scan will be performed within 2 weeks prior to the start of radiotherapy (and within 1 week of the pre-radiotherapy FDG PET-CT scan). You will not need to fast for this scan. An IV cannula will be inserted and the tracer will be injected, you will need to wait for 120 minutes before the PET-CT scan is started. The scan should take approx 30 minutes. One contrast enhanced thoracic CT scan will be performed within 2 weeks prior to the start of radiotherapy and another will be performed 6 weeks after completion of radiotherapy to assess the response to the treatment. Participants will be followed up 3 weeks post radiotherapy, 6 weeks post-radiotherapy and then every 8 weeks to determine the symptomatic response to radiotherapy. Follow up will occur as part of your normal outpatient visits and will involve completion of pain scores and quality of life and medication questionnaires. You will attend follow-up appointments every 8 weeks until you require additional treatment (such as increased pain medication or chemotherapy) or until 6 months after the last study participant has been recruited (whichever is earliest). Using an integrated approach (including innovative imaging techniques that target different tumour characteristics (F-MISO PET, FDG PET), biomarkers and plausible and established clinical markers) this study will also examine the role of hypoxia as imaged by F-MISO PET in radio resistance of symptomatic mass lesions in MPM and identify other clinical and biological predictors of response to radiotherapy. We hypothesise that greater lesion hypoxia, anaemia, and systemic hypoxaemia will be associated with lower radiological response rates and both poorer and shorter duration of symptom control

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