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Trial registered on ANZCTR


Registration number
ACTRN12622001215718p
Ethics application status
Submitted, not yet approved
Date submitted
26/07/2022
Date registered
9/09/2022
Date last updated
9/09/2022
Date data sharing statement initially provided
9/09/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Feasibility of novel endoscopic imaging techniques during transbronchial lung biopsy in interstitial lung disease
Scientific title
Feasibility of novel endoscopic imaging techniques during transbronchial lung biopsy in interstitial lung disease
Secondary ID [1] 307642 0
Nil
Universal Trial Number (UTN)
Trial acronym
FROID (Feasibility of novel endoscopic imaging techniques during transbronchial lung cRyobiOpsy in Interstitial Lung Disease)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Interstitial lung disease 327166 0
Condition category
Condition code
Respiratory 324302 324302 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Interventional - single-arm study

Exposure: endoscopic imaging of the lung parenchyma using confocal laser endomicroscopy (CLE) and radial endobronchial ultrasound (radial EBUS) in unclassifiable interstitial lung disease (ILD) prior to undergoing transbronchial lung cryobiopsy (TBLC).

• Patients with unclassifiable ILD who have been referred for TBLC will be enrolled.
• All procedures will be performed by two respiratory physician bronchoscopists, one of whom has extensive experience in the performance of TBLC.
• Participant recruitment is estimated to take up to 6 months in duration.
• Participants will undergo a TBLC procedure following standard practice at the treating institution (compliant with international expert guidelines on the performance of cryobiopsy). Three ipsilateral target sites for TBLC will be selected prior to the procedure after review of CT imaging and discussion at an interstitial lung disease multidisciplinary meeting. They will be performed under fluoroscopy guidance and general anaesthesia.
• Prior to the biopsies being taken, all the target sites will be viewed with (1) radial EBUS, followed by (2) CLE. The recorded images will not be used to guide the site of biopsy selection. Images will be compared to final histologic findings.
• The radial EBUS component will involve interrogation of the target site distal airway (approximately the distal 3cm) with the EBUS probe. CLE will involve interrogation of the same airway segment with a thin, flexible endomicroscopy probe that is inserted through the working channel of the bronchoscope. The position of both probes will be confirmed on fluoroscopy.
• The combined time of radial EBUS and CLE in addition to the standard TBLC is estimated to be 15 minutes. The baseline average duration of TBLC is 45 minutes.
• Adherence to the intervention protocol will be documented by in the record of the crobiopsy session, including identification of all biopsy sites with and the related imaging findings from the various imaging modalities.
• No specific contrast dyes or other markers will be administered to participants.


Patients with unclassifiable ILD who have been referred for TBLC will be enrolled. Three target sites for biopsy will be examined with radial EBUS then CLE prior to TBLC at the same location under fluoroscopy guidance. Imaging findings on radial EBUS and CLE will be compared to histologic findings.
Intervention code [1] 324112 0
Diagnosis / Prognosis
Comparator / control treatment
Comparator - histology obtained from transbronchial lung cryobiopsy.

This will be used to assess the diagnostic yield of radial EBUS and CLE to accurately identify abnormalities of lung parenchyma.
Control group
Active

Outcomes
Primary outcome [1] 332114 0
Diagnostic yield of endoscopic imaging (radial EBUS and CLE) in ILD:
- Expressed as a proportion (denominator = TBLC biopsies that produced a pathological diagnosis, numerator = number of these sites where endoscopic imaging demonstrated abnormal parenchymal findings)
Timepoint [1] 332114 0
Day of cryobiopsy procedure.
Secondary outcome [1] 412279 0
Inter-observer variability in the interpretation of endoluminal imaging:
- Concordance between investigators in interpretation of endoscopic imaging, based on assessment of study records where individual investigators have indicated the presence or absence of pre-determined imaging features.
Timepoint [1] 412279 0
Day of cryobiopsy procedure.
Secondary outcome [2] 412281 0
Correlation between endoscopic imaging descriptors, histology and radiological findings (as seen on high-resolution computed tomography of the chest.
Timepoint [2] 412281 0
Day of cryobiopsy procedure.
Secondary outcome [3] 413423 0
Safety outcomes as measured by the incidence of complications.
- Examples of complications include: bleeding (British Thoracic Society severity score), pneumothorax, pain, infection, exacerbation of ILD, requirement for unplanned overnight admission, respiratory failure.
- Assessment will occur by review of medical records.
Timepoint [3] 413423 0
Day of cryobiopsy procedure.

Eligibility
Key inclusion criteria
- Adults aged 18 years or older
- Working diagnosis of unclassifiable interstitial lung disease or a low confidence diagnosis
- Referred for cryobiopsy following discussion at an ILD multidisciplinary meeting
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Reduced lung function (FVC less than 50% predicted; or FEV1 less than 50% predicted or less than 0.8L; or DLCO less than 50% predicted or less than 35 units)
• Uncontrolled bleeding diathesis
• American Society of Anesthesiology Status of III or higher
• Hypoxaemia (PaO2 less than 55 to 60mmHg on room air or while receiving 2L/minute nasal oxygen)
• Pulmonary hypertension (sPAP greater than 50mmHg)
• Body mass index greater than 35kg/m2
• Inability to give informed consent
• Vulnerable population (inability to understand English, pregnant women, prisoner)

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
- Diagnostic/feasibility outcomes: diagnostic yield
- Inter-/intra-observer variability: Kappa coefficient
- Correlation between imaging descriptors and pathology: Kappa coefficient
- Procedure time: mean, range
- Comparison between radiologic, histopathologic and endoscopic imaging appearance: 2x2 Fishers test
- Description of participant characteristics: mean, range

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
15/09/2022
Actual
Date of last participant enrolment
Anticipated
1/04/2023
Actual
Date of last data collection
Anticipated
1/05/2023
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 22863 0
Royal Melbourne Hospital - City campus - Parkville
Recruitment postcode(s) [1] 38170 0
3050 - Parkville

Funding & Sponsors
Funding source category [1] 311904 0
Hospital
Name [1] 311904 0
Royal Melbourne Hospital
Country [1] 311904 0
Australia
Primary sponsor type
Hospital
Name
Royal Melbourne Hospital
Address
300 Grattan St
Parkville
VIC 3050
Country
Australia
Secondary sponsor category [1] 313386 0
None
Name [1] 313386 0
Address [1] 313386 0
Country [1] 313386 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 311340 0
Royal Melbourne Hospital HREC
Ethics committee address [1] 311340 0
300 Grattan St
Parkville
VIC 3050
Ethics committee country [1] 311340 0
Australia
Date submitted for ethics approval [1] 311340 0
27/07/2022
Approval date [1] 311340 0
Ethics approval number [1] 311340 0

Summary
Brief summary
The proposed single-arm study will investigate the feasibility and utility of CLE and radial EBUS for the detection of lung parenchymal abnormalities in people with ILD. The study will establish the diagnostic yield of radial EBUS and CLE in detection of parenchymal abnormalities in patients with radiologic ILD, by comparing these techniques to the gold standard test of histology, as well as high-resolution CT chest imaging. Real-time assessment and recording of video imaging for later, de-identified review will also permit determination of intra-observer and inter-observer variability. Additional secondary outcomes include safety.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 120770 0
A/Prof Daniel Steinfort
Address 120770 0
C/o Respiratory Department
Royal Melbourne Hospital
300 Grattan St
Parkville
VIC 3050
Country 120770 0
Australia
Phone 120770 0
+61 03 9342 7000
Fax 120770 0
Email 120770 0
[email protected]
Contact person for public queries
Name 120771 0
Julia Lachowicz
Address 120771 0
C/o Respiratory Department
Royal Melbourne Hospital
300 Grattan St
Parkville
VIC 3050
Country 120771 0
Australia
Phone 120771 0
+61 03 93427000
Fax 120771 0
Email 120771 0
[email protected]
Contact person for scientific queries
Name 120772 0
Julia Lachowicz
Address 120772 0
C/o Respiratory Department
Royal Melbourne Hospital
300 Grattan St
Parkville
VIC 3050
Country 120772 0
Australia
Phone 120772 0
+61 03 93427000
Fax 120772 0
Email 120772 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


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
16734Study protocol    Contact person for scientific queries
16735Ethical approval    Pending approval



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.