Topic: Cancer
Conditions
Interventions
Participants are randomly allocated to one of two groups.
Intervention group: Participants will undergo a PET-CT scan prior to their CT guided biopsy. The PET-CT images and reports will be made avail
Sponsors
North Bristol NHS Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Current participant inclusion criteria as of 17/11/2017: Participants may be eligible for the study if ALL the following apply: 1. Pleural thickening on CT suspicious for pleural malignancy 2. Have had any form of pleural biopsy in the last 12 months (either by thoracoscopy or under radiological guidance) which was non-diagnostic for cancer 3. Lung Cancer/mesothelioma MDT decision to perform further CT-guided biopsy to pursue a diagnosis Previous participant inclusion criteria: 1. Aged 18 years or over 2. Pleural thickening on CT suspicious for malignancy 3. Have had any for of pleural biopsy in the last 6 months (either by thoracoscopy or under radiological guidance) which was nondiagnostic for cancer 4. Lung Cancer/Mesothelioma Multidisciplinary team (MDT) decision to perform further CT guided biopsy to pursue a diagnosis
Exclusion criteria
Exclusion criteria: Current exclusion criteria as of 17/11/2017: Participants may not enter study if ANY of the following apply: 1. Unsuitable for a CT guided biopsy – inability to co-operate, lie still for the duration of the biopsy, uncorrectable coagulopathy, inability to tolerate a pneumothorax, severe underlying lung disease (patients with an FEV1 < 35% assessed using simple spirometry, see section 5.3.1) 2. Unable to give written informed consent 3. Pregnancy or lactation 4. Age <18 years 5. Pleural thickening not amenable to a radiologically guided biopsy 6. Talc pleurodesis in the previous 6 months Previous exclusion criteria: 1. Unsuitable for CT guided biopsy inability to cooperate, lie still for the duration of the biopsy, uncorrectable coagulopathy, inability to tolerate a pneumothorax, severe underlying lung disease (patients with an FEV1 <35% assessed using simple spirometry) 2. Unable to give written informed consent 3. Pregnancy or lactation 4. Aged under 18 years 5. Pleural thickening not amenable to Trucut biopsy 6. Prior Talc pleurodesis
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Diagnostic accuracy of the PET-CT scan in the detection of pleural malignancy is determined using biposy results. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Diagnostic delay 2. Number of hospital attendances 3. Number of invasive pleural procedures 4. Survival 5. Costs associated with health related resource use 6. Mesothelin levels | — |
Countries
England, Scotland, United Kingdom, Wales
Contacts
Public ContactLucy Ellis
Outcome results
None listed