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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]

Nil Known

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Lung cancer

bronchoscopy

pulmonary nodule

Condition category

Condition code

Cancer

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]

Diagnosis / Prognosis

Comparator / control treatment

No control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

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]

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]

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]

Post bronchoscopy
For benign diagnoses, diagnostic yield will be followed up for a minimum of 3 months.

Secondary outcome [2]

Length of procedure - the duration from start of anaesthetic to completion of anaesthetic

Timepoint [2]

Will be documented at the completion of each procedure

Secondary outcome [3]

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]

Radiation dose will be documented at the completion of each procedure

Secondary outcome [4]

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]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Recruitment hospital [1]

The Royal Adelaide Hospital - Adelaide

Recruitment postcode(s) [1]

5000 - Adelaide

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

Royal Adelaide Hospital

Address [1]

Port Road, Adelaide, Australia 5000

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

CALHN HREC

Ethics committee address [1]

Central Adelaide Local Health Network, Royal Adelaide Hospital , 1 Port Road, Adelaide, South Australia 5000

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

01/03/2023

Approval date [1]

29/06/2023

Ethics approval number [1]

2023/HRE00015

Summary

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.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Michael Brown

Address

Royal Adelaide Hospital, 1 Port Road, Adelaide, South Australia 5000

Country

Australia

Phone

+61 408804683

Fax

[email protected]

Contact person for public queries

Name

Michael Brown

Address

Royal Adelaide Hospital, 1 Port Road, Adelaide, South Australia 5000

Country

Australia

Phone

+61 8 7074 5000

Fax

[email protected]

Contact person for scientific queries

Name

Michael Brown

Address

Royal Adelaide Hospital, 1 Port Road, Adelaide, South Australia 5000

Country

Australia

Phone

+61 8 70745000

Fax

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

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.	Type	Citation	Link	Email	Other Details	Attachment
20042	Study protocol					386441-(Uploaded-16-08-2023-16-04-22)-Study-related document.docx
20043	Informed 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.

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