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Trial registered on ANZCTR


Registration number
ACTRN12623000875606
Ethics application status
Approved
Date submitted
21/07/2023
Date registered
15/08/2023
Date last updated
15/08/2023
Date data sharing statement initially provided
15/08/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Outcome of Bronchoscopic Robot Sampling (ION) of lung nodules
Scientific title
Comparing outcomes of Bronchoscopic Robot (ION) with Endobronchial Ultrasound (EBUS) Guide sheath sampling of lung nodules- diagnostic yield and resource utilisation.
Secondary ID [1] 310171 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Lung nodules 330748 0
Lung cancer 330749 0
Lung biopsy 330750 0
Lung cancer- non small cell 330752 0
Condition category
Condition code
Cancer 327588 327588 0 0
Lung - Non small cell
Respiratory 327855 327855 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 326564 0
Diagnosis / Prognosis
Intervention code [2] 326636 0
Treatment: Devices
Comparator / control treatment
Comparator control group is a retrospective data set of procedures by the same 2 operators prior to starting use of ION.
We have long performed a biopsy called EBUS Guide sheath, which uses a scope into the lungs under anaesthetic. We have performed a retrospective audit of our results from that.
This is called ebus guide sheath. It similarly uses a scope into the lungs to sample lung nodules- an ultrasound probe is used to confirm localiisation of the nodule prior to biopsy.. Real time computer guided navigation is not used. The scope is completely guided by the operator.
The procedure takes 30-40 minutes. Success of that procedure will be determined by results of pathology on biopsies- positive or negative.
All participants admitted to the Royal Brisbane and Women's Hospital Thoracic Medicine department who underwent nodule biopsy by EBUS guide sheath between 1 April 2017 to 30 September 2018 will be included as the comparator group.
Control group
Historical

Outcomes
Primary outcome [1] 335423 0
Positive pathology results of samples from ION bronchoscopy, whether malignant (lung cancer) or benign (such as a granuloma or an infection.)
Timepoint [1] 335423 0
From each procedure within 7 days.
Secondary outcome [1] 424478 0
Number of additional biopsies completed, determined from a review of medical records and study-specific questionnaire
Timepoint [1] 424478 0
Over the course of 12 months after the sampling procedure for each patient
Secondary outcome [2] 424913 0
Number of additional clinic visits, determined from a review of medical records and study-specific questionnaire
Timepoint [2] 424913 0
Over the course of 12 months after the sampling procedure for each patient
Secondary outcome [3] 424914 0
Number of additional radiologic tests completed, determined from a review of medical records and study-specific questionnaire.
Timepoint [3] 424914 0
Over the course of 12 months after the sampling procedure for each patient
Secondary outcome [4] 424915 0
Number of admissions for pneumothorax complications, determined from a review of medical records and study-specific questionnaire.
Timepoint [4] 424915 0
Over the course of 12 months after the sampling procedure for each patient
Secondary outcome [5] 424916 0
Number of patients with post-biopsy bleeding, determined from a review of medical records and study-specific questionnaire
Timepoint [5] 424916 0
Over the course of 12 months after the sampling procedure for each patient

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
The study will compare outcomes of ION to results of biopsy success from a historic control group from the same bronchoscopy unit, using all cases having EBUS Guide sheath biopsy of a nodule before the ION procedures commenced..
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
Descriptive statistics and qualitative analysis for specified endpoints will be performed. Basic data collected will also be reported; where available, analysis results will be compared to peer-reviewed literature data and existing data from our previous Guide-sheath EBUS procedures.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
4/09/2023
Actual
Date of last participant enrolment
Anticipated
1/09/2024
Actual
Date of last data collection
Anticipated
1/09/2025
Actual
Sample size
Target
70
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 25229 0
Royal Brisbane & Womens Hospital - Herston
Recruitment postcode(s) [1] 40898 0
4029 - Herston

Funding & Sponsors
Funding source category [1] 314333 0
Hospital
Name [1] 314333 0
Royal Brisbane and Womens Hospital
Country [1] 314333 0
Australia
Primary sponsor type
Hospital
Name
Royal Brisbane and Womens Hospital
Address
Butterfield Street
Herston
Qld 4029
Country
Australia
Secondary sponsor category [1] 316281 0
Government body
Name [1] 316281 0
Metro North Hospital Health Service
Address [1] 316281 0
Block 7
Butterfield Street
Herston
Qld 4029
Country [1] 316281 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313434 0
Metro North Health Human Research Ethics Committee
Ethics committee address [1] 313434 0
Ethics committee country [1] 313434 0
Australia
Date submitted for ethics approval [1] 313434 0
28/02/2023
Approval date [1] 313434 0
26/04/2023
Ethics approval number [1] 313434 0
94938Approval

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 128146 0
A/Prof David Fielding
Address 128146 0
Dept Thoracic Medicine
Royal Brisbane and Women's Hospital
Butterfield Street
Herston
Qld 4029
Country 128146 0
Australia
Phone 128146 0
+61736464241
Fax 128146 0
+61 7 36465651
Email 128146 0
david.fielding@health.qld.gov.au
Contact person for public queries
Name 128147 0
David Fielding
Address 128147 0
Dept Thoracic Medicine
Royal Brisbane and Women's Hospital
Butterfield Street
Herston
Qld 4029
Country 128147 0
Australia
Phone 128147 0
+61736464241
Fax 128147 0
+61 7 36465651
Email 128147 0
david.fielding@health.qld.gov.au
Contact person for scientific queries
Name 128148 0
David Fielding
Address 128148 0
Dept Thoracic Medicine
Royal Brisbane and Women's Hospital
Butterfield Street
Herston
Qld 4029
Country 128148 0
Australia
Phone 128148 0
+61736464241
Fax 128148 0
+61 7 36465651
Email 128148 0
david.fielding@health.qld.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
all radiologic , procedural, saftey and biopsy data
When will data be available (start and end dates)?
after 12 months and available for 5 years after publication,
Available to whom?
at time of publication for general public. Data will be monitored by Data safety monitoring board throughout the study.
Available for what types of analyses?
For primary and secondary outcomes only to achieve the aims in the study protocol,
How or where can data be obtained?
unrestricted access via web address to be created at time of publication. DSMB can access through Redcap by contacting the study chief investigator- Dr David Fielding
Dept Thoracic medicine
Royal Brisbane and Women's Hospital
Butterfield Street
Herston
Qld 4029


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.