Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000938606
Ethics application status
Approved
Date submitted
16/08/2023
Date registered
30/08/2023
Date last updated
30/08/2023
Date data sharing statement initially provided
30/08/2023
Type of registration
Retrospectively registered

Titles & IDs
Public title
Cone beam Computed Tomography guided radial Endobronchial Ultrasound (EBUS) for the diagnosis of Peripheral Pulmonary lesions.
Scientific title
Cone beam Computed Tomography guided radial Endobronchial Ultrasound (EBUS) for the diagnosis of Peripheral Pulmonary lesions.
Secondary ID [1] 310401 0
Nil Known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Lung cancer 331152 0
bronchoscopy 331155 0
pulmonary nodule 331156 0
Condition category
Condition code
Cancer 327929 327929 0 0
Lung - Non small cell

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 326802 0
Diagnosis / Prognosis
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 335786 0
Navigational yield - this will be confirmed based on the CT cone beam image. A confirmed navigational yield will demonstrate the biopsy forceps within the target lesion. If the navigation yield is negative, a re-adjustment maneuver will be made.
Timepoint [1] 335786 0
Recorded during bronchoscopy procedure
the recruitment period of the trial will be 12 months. Each individual patient will have a singular procedure (no repeat procedures) lasting approximately 1 hour in duration. Individual patients will have 3 months of follow up to monitor for complications (below) and to confirm (if required) diagnostic outcomes.
Secondary outcome [1] 425628 0
Diagnostic yield - this will be determined from the histological analysis conducted by SA pathology. A positive diagnostic yield will be one in which there is a malignant or specific benign diagnosis. A negative diagnostic yield will be one in which there is no clear diagnosis and includes benign diagnoses such as inflammation.
Timepoint [1] 425628 0
Post bronchoscopy
For benign diagnoses, diagnostic yield will be followed up for a minimum of 3 months.
Secondary outcome [2] 425902 0
Length of procedure - the duration from start of anaesthetic to completion of anaesthetic
Timepoint [2] 425902 0
Will be documented at the completion of each procedure
Secondary outcome [3] 425903 0
Radiation dosage - will be collated from the CT O'arm device. The CT O'arm is capable of both fluoroscopy and CT imaging and records the radiation output given to the patient in Gycm2.
Timepoint [3] 425903 0
Radiation dose will be documented at the completion of each procedure
Secondary outcome [4] 425904 0
Complications - include sore throat, cough, bleeding and pneumothorax (the most common). other less common complications include infection (pneumonia). Death is a rare complication of bronchoscopy.
Timepoint [4] 425904 0
These will be documented at the completion of each individual procedure. The patient notes will also be reviewed at 3 months to confirm the presence or absence of additional complications such as pneumonia

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

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
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
4/08/2023
Date of last participant enrolment
Anticipated
1/06/2024
Actual
Date of last data collection
Anticipated
1/09/2024
Actual
Sample size
Target
30
Accrual to date
3
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 25397 0
The Royal Adelaide Hospital - Adelaide
Recruitment postcode(s) [1] 41136 0
5000 - Adelaide

Funding & Sponsors
Funding source category [1] 314607 0
Hospital
Name [1] 314607 0
Royal Adelaide Hospital
Country [1] 314607 0
Australia
Primary sponsor type
University
Name
The University of Adelaide
Address
The University of Adelaide, 230 North Terrace, Adelaide, South Australia 5005
Country
Australia
Secondary sponsor category [1] 316570 0
None
Name [1] 316570 0
Address [1] 316570 0
Country [1] 316570 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313636 0
CALHN HREC
Ethics committee address [1] 313636 0
Ethics committee country [1] 313636 0
Australia
Date submitted for ethics approval [1] 313636 0
01/03/2023
Approval date [1] 313636 0
29/06/2023
Ethics approval number [1] 313636 0
2023/HRE00015

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

Contacts
Principal investigator
Name 128822 0
Dr Michael Brown
Address 128822 0
Royal Adelaide Hospital, 1 Port Road, Adelaide, South Australia 5000
Country 128822 0
Australia
Phone 128822 0
+61 408804683
Fax 128822 0
Email 128822 0
[email protected]
Contact person for public queries
Name 128823 0
Michael Brown
Address 128823 0
Royal Adelaide Hospital, 1 Port Road, Adelaide, South Australia 5000
Country 128823 0
Australia
Phone 128823 0
+61 8 7074 5000
Fax 128823 0
Email 128823 0
[email protected]
Contact person for scientific queries
Name 128824 0
Michael Brown
Address 128824 0
Royal Adelaide Hospital, 1 Port Road, Adelaide, South Australia 5000
Country 128824 0
Australia
Phone 128824 0
+61 8 70745000
Fax 128824 0
Email 128824 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Individual patient data will be de-identified and then will undergo statistical analysis. The statistics will be published. No identifiable patient data will be published.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
20042Study protocol    386441-(Uploaded-16-08-2023-16-04-22)-Study-related document.docx
20043Informed consent form    386441-(Uploaded-16-08-2023-16-04-38)-Study-related document.docx



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.