None listed
Conditions
Brief summary
Brief description of the study purpose You may be eligible for this study if you attend either the Royal Brisbane & Womens Hospital in Queensland or the Sir Charles Gairdner Hospital in Western Australia and have a nodule on the lung suspicious for cancer. Who is it for? Your doctor has sent you to have tests to investigate a spot (nodule) on your lung. Taking samples of the nodule may require by a bronchoscopy ( a camera into the lung) or samples taken with a thin needle passed directly into the nodule through the chest wall (directed by a CAT scanner). Study details PET/CT scans are approved in Australia when patients have lung nodules PET/CT scans are a way to take pictures of the lung and the rest of the body to show up “hot spots”and whether there are any other hot spots in the body that need to sampled. This study is seeing how putting PET/CT first (ie before any other tests) might improve the way all nodules are tested. If other spots in the lung or in lymph nodes or in other parts of the body are shown on PET/CT scan before any biopsies are done, it may be that doctors decide to biopsy those other spots first, rather than the nodule, to give the best information to allow treatment of your condition with one test, not two or three. All study participants will have a PET/CT first. They will also have detailed CT scan of the chest up front as well to possibly improve detection of the nodule. They will aslo all have a blood test, to study the use of new technology to confirm whether a nodule may be cancerous by just doing a blood test. There is no randomisation and all patients will have these tests before their other investigations. The purpose of this study is to determine whether using a test first (a PET/CT scan) when diagnosing cancer, changes the way a cancer is tested- which sampling test should come first. We hope it improves health outcomes by reducing the total number of tests a patient needs.
Interventions
1. A PET/CT to determine which diagnostic procedure should be done first- all subjects in the study have this. This is done once at study entry. Initially the referral CT scan will be reviewed by the study group for every patient and a provisional diagnostic test will be recommended( EBUS Guide sheath versus CT FNA versus Surgical excision biopsy versus observation and repeat scan). Then ALL patients have a PET/CT - on the study hospital campus- (RBWH / Sir Charles Gairdner Hospital. ) . The st
1. A PET/CT to determine which diagnostic procedure should be done first- all subjects in the study have this. This is done once at study entry. Initially the referral CT scan will be reviewed by the study group for every patient and a provisional diagnostic test will be recommended( EBUS Guide sheath versus CT FNA versus Surgical excision biopsy versus observation and repeat scan). Then ALL patients have a PET/CT - on the study hospital campus- (RBWH / Sir Charles Gairdner Hospital. ) . The study group will then RECONVENE after the PET/CT is done and review that original biopsy choice decision based on alternate targets revealed by the PET/ CT. It is only then that the diagnostic test will actually be done- on the basis of those reviews. The diagnostic tests will be done in the usual way by the thoracic team- patients are not randomised to a specific intervention, only allocated on the basis of the PET CT and how it changes the initial diagnostic test. If a PET/CT has been done elsewhere, that study can be used in the evaluations as above without repeating it. 2. A CT low dose) to enable detailed assessment of a nodule particularly with a view to virtual bronchoscopy planning. This is done in all cases, once at study entry, at the same time as the PET/CT and is similarly reviewed by the study group and the radiologist to determine the presence or absence of a bronchus sign and how this differs from the referral CT and how this may influence the decision for a bronchoscopic approach. That is, it is reviewed once, by the radiologists as part of the study team, before any biopsy is done. We would check that such a scan had not been done before referral. 3. Blood test sampling for exosome analysis. This is done once at study entry at the time of insertion of cannula for the PET CT procedure. This does not influence management and does not lead to any intervention in itself.
Sponsors
Royal Brisbane and Womens Hospital
Study design
Allocation
Non-randomised trial
Primary purpose
Diagnosis
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
• Referrals to Thoracic Medicine OPD or Inpatient Consults • Nodules 8-30mm diameter, solid or semi-solid • Brock risk calculator risk of malignancy of >10%
Exclusion criteria
• Unsuitable for bronchoscopy • where nodules have morphology clearly suggestive of benign disease per BTS guidelines peri-fissural or subpleural nodules less than 10 mm diameter. o Ground Glass opacity nodules with less than 5 mm solid component – see reference • Pregnant or lactating women
Outcome results
None listed