None listed
Conditions
Brief summary
This study will investigate the effect of adding CT imaging to guide the standard endobrachial ultrasound (EBUS) method of collecting lung tissue for the diagnosis of potential lung cancers. Who is it for? You may be eligible for this study if you are an adult ages 18 years or older, you live in South Australia and you have been referred to the Royal Adelaide Hospital lung cancer clinic with a pulmonary lesion (suspected lung cancer) that requires a biopsy to be taken. Only participants who are eligible to undergo a radial EBUS procedure will be invited to participate in this study. Study details All participants who choose to enrol in this study will undergo a general anaesthetic in order to have the EBUS procedure. The EBUS procedure will be undertaken per the standard method, which involves introducing a flexible camera (bronchoscope) into the participants airway via their throat. An ultrasound probe will also be used to identify the lesion to be biopsied. As part of this study, additional CT imaging will also take place prior to the lesion being biopsied. This imaging will not involve any additional injections and is anticipated to add 15 minutes to the overall procedure and anaesthesia time. It is hoped this research will determine whether adding CT imaging during the lung biopsy procedure is able to improve the ability of surgeons and physicians to collect the tissue sample accurately and with fewer attempts. If this imaging is found to have a positive impact on the accuracy and duration of the biopsy procedure it may be trialled in a larger number of potential lung cancer patients in a future clinical trial.
Interventions
This is a prospective trial of a novel diagnostic method for challenging pulmonary nodules, which includes lung cancers. Currently, pulmonary nodules are biopsied using radial endobronchial ultrasound (EBUS), in-which a bronchoscope is inserted through the vocal cords and into the lungs. A small spinning ultrasound probe is inserted along the working channel of the bronchoscope. The ultrasound is used to identify the target pulmonary nodule. Forceps are then inserted through the working channel
This is a prospective trial of a novel diagnostic method for challenging pulmonary nodules, which includes lung cancers. Currently, pulmonary nodules are biopsied using radial endobronchial ultrasound (EBUS), in-which a bronchoscope is inserted through the vocal cords and into the lungs. A small spinning ultrasound probe is inserted along the working channel of the bronchoscope. The ultrasound is used to identify the target pulmonary nodule. Forceps are then inserted through the working channel and under 2D fluoroscopic guidance the lesion is biopsied. The yield of this process is limited. This project employs 3D-imaging guidance using a CT Cone beam, (CT O'arm). The role of the CT O'arm is to demonstrate the relationship of the sampling tools relative to the lesion. This means that if the biopsy tool is not within the lesion, it can be readjusted. The duration of the procedure takes 45-60minutes including all biopsies. This compares to standard of care which takes 30-45 minutes. No additional contrast dyes or other markers are needed for the patient. A trained interventional pulmonologist will perform the procedure and take the biopsies, however a radiographer will be present in the room to use the CT O'arm and ensure its correct use. The outcomes of the procedure will be recorded on a data spreadsheet post procedure to ensure adherence to the intervention.
Sponsors
The University of Adelaide
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Diagnosis
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patients referred to the lung cancer clinic with a peripheral pulmonary lesion that requires a histological diagnosis. Lung nodules with both a high and low pre-test probability of malignancy will be included. Patients will only be included if radial EBUS is the required diagnostic procedure
Exclusion criteria
Patients will be excluded if they are unable to give consent, pregnant or likely to be pregnant at the time of recruitment or they are less than 18 years of age. Patients in whom an alternative procedure such as linear EBUS, CT guided biopsy or endobronchial biopsy will also be excluded.
Outcome results
None listed