None listed
Conditions
Brief summary
This study aims to compare the use of a robotic-assisted system and the current standard of care ultrasound-guided method for taking lung biopsy samples. Who is it for? You may be eligible for this study if you are aged 18 years or older and you are eligible to undergo an elective lung nodule biopsy at the Royal Brisbane & Womens Hospital. Study details All participants who choose to enrol in this study will have had a lung/chest CT scan taken prior to their enrolment. This scan will be used to plan how best the lung catheter and camera (bronchoscope) can be directed to collect samples of their lung tissue using the robotic-assisted bronchoscope (ION) System. Participants will be admitted as day patients at the Royal Brisbane & Womens Hospital and will undergo general anaesthesia in order to have the biopsy samples taken. It is anticipated that the procedure will take up to 45 minutes to complete. Once participants have recovered from the anaesthesia they will be able to go home. The samples taken by the robotic-assisted system will be processed to determine the likelihood that the tissue contains cancer cells. The results from an historical group of patients who had lung biopsies taken using the standard of care ultrasound-guided method will be used as a comparator to determine the safety and efficacy of the robotic-assisted method. It is hoped this research will determine whether use of the robotic-assisted system is able to provide more accurate tissue samples for assessment compared to the ultrasound-guided system. If the robotic-assisted system is found to be more effective and just as safe, if not safer, than the current standard of care method, use of the robotic-assisted system may be tested in a larger number of patients.
Interventions
Brief name: Lung nodule biopsy using ION robot
Regarding ION robotic bronchoscopy
-Sampling is done under an anaesthetic and uses cameras into the lung. In 2019 we published results from the RBWH Study of the first in human study of use of a scope for sampling lung nodules called a bronchoscopic robot. That device has now been approved by the FDA and marketed and is called ION. The device is operated by the bronchoscopist and uses a computerised pathway which the bronchoscopist "follows" with
Brief name: Lung nodule biopsy using ION robot Regarding ION robotic bronchoscopy -Sampling is done under an anaesthetic and uses cameras into the lung. In 2019 we published results from the RBWH Study of the first in human study of use of a scope for sampling lung nodules called a bronchoscopic robot. That device has now been approved by the FDA and marketed and is called ION. The device is operated by the bronchoscopist and uses a computerised pathway which the bronchoscopist "follows" with a robotic tube (catheter). Once in location at the target nodule samples are taken (biopsies). The nature of these samples is exactly the same as for the "Standard of Care" biopsy known as ebus guide sheath (forceps, biopsies, needle and brush cytology and washes for cytology and culture. ION incorporates a range of technical aspects in one device where these aspects are added to the other techniques - small probe catheter to allow navigation deep into the lung - highly directional navigation to reach nodules in difficult locations - CT derived virtual bronchoscopy plan (usually done as a separate modality with EBUS Guide sheath, ie viewed separately not integrated into one system) - stable platform to take biopsies once the nodule reached (usual methods are hampered by scope slippage and loss of position) -the anticipated time needed to complete the biopsy procedure is 30-45 minutes - the anticipated time needed to prepare the detailed plan of the procedure using the participant's CT scan is 20 minutes per participant. This plan is anticipated to be completed 24 hours prior to the procedure itself. The detailed plan is created by importing CT images into the software- the doctor confirms the nodule in question on the computer and a pathway is automatically generated. That pathway is then loaded into the software program of the robot by a USB. The plan is used during navigation of the catheter to the nodule by displaying the plan side by side with the moving real image of the airway- the doctor drives the catheter in the real airway by watching the plan in an adjacent screen. the sampling procedure. - To monitor adherence to the robotic procedure all biopsy methods and the number of stations of biopsy adjacent to the nodule are recorded during the procedure, along with results of rapid -on-site cytology of samples during the procedure. A total of 140 patients will be studied, 70 prospective and 70 retrospective, all patients from our own clinic. The study is unique because the same operators will have performed both procedure types to allow the comparison. - patients will have day case outpatient procedure in a dedicated procedure suite at Royal Brisbane and Women's Hospital Thoracic Medicine department. Patients will have a general anaesthetic during which a small catheter is guided to the site of the nodule and pathology samples are taken to make the diagnosis of the nodule. Physically it has the same effect on the body as any other lung biopsy. Patients will have only 1 procedure for the nodule. It is not a surgery. - two specialists will work together to do the procedure, both of whom participated in the first in human study prototype which led to the development of the current robot (called "ION"). They have extensive clinical experience (40 years between them) in all forms of bronchoscopic biopsy and have had multiple training sessions in lab conditions using the ION robot. - these specialists prepare a detailed plan of the procedure beforehand using software applied to the patient's own CT scan- a pathway to the nodule is created. Intervention fidelity (success of the ION biopsy) will be assessed by positive or negative results on the pathology of the biopsies. Safety will also be assessed with well-defined criteria, and a data safety monitoring board.
Sponsors
Royal Brisbane and Womens Hospital
Study design
Allocation
Non-randomised trial
Intervention model
Other
Primary purpose
Diagnosis
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
• Patient is suitable for elective nodule biopsy via bronchoscopy under general anaesthesia per Investigator’s discretion. • Patient has solid or semi-solid pulmonary nodule(s) of 8 mm to 30 mm in largest dimension (based on pre-procedure CT scan) • Pulmonary nodule(s) intended for biopsy during the study procedure is (are) located at least 4 airway generations out (trachea is generation 0, e.g. subsegmental bronchi or beyond) based on pre-procedure CT scan • Patient has a moderate to high risk of lung cancer based on clinical, demographic, and radiologic information or with suspected metastatic disease. • Patient is willing and able to give written informed consent for Clinical Investigation participation. Patient is not legally incapacitated or in a legal/court ordered institution.
Exclusion criteria
• Patient has a lack of fitness or exercise capacity to undergo bronchoscopy under general anesthesia as determined by physician prior to procedure. • Presence of suspicious mediastinal nodal disease on pre-procedure CT or PET-CT scan. • Requirement for any invasive concomitant procedure (outside of lymph node staging) not related to the pulmonary nodule or suspected disease state. • Female patient of child-bearing potential who is unable to take adequate contraceptive precautions or is known to be pregnant, and/or breast feeding. • Patient has a documented medical history of uncorrectable coagulopathy, bleeding, or platelet disorder. • Patient is taking antiplatelet or anticoagulant medications that cannot be stopped per standard practice. • Patient is currently participating or has participated in another Clinical Investigation within the past 30 days, such as interventional trials or trials with experimental agents or agents of unknown risk, that may affect the endpoints of this Clinical Investigation. • Patient is not willing to comply with post study procedure participation requirements.
Outcome results
None listed