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Trial registered on ANZCTR


Registration number
ACTRN12618000068268
Ethics application status
Approved
Date submitted
25/10/2017
Date registered
17/01/2018
Date last updated
17/01/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
Assessing the ability to obtain a larger tissue sample using a novel Gen cut tool and Radial EBUS for abnormal lung lesions suspected of cancer.
Scientific title
Assessing the ability to obtain a core biopsy from peripheral lung lesions (PPL) using the novel Gen Cut tool with Radial EBUS (R-CORE) - multi-center prospective interventional pilot study
Secondary ID [1] 293216 0
None
Universal Trial Number (UTN)
U1111-1204-2333
Trial acronym
R CORE
Linked study record
None

Health condition
Health condition(s) or problem(s) studied:
Abnormal lung lesions 305227 0
Suspected lung cancer 305229 0
Condition category
Condition code
Cancer 304532 304532 0 0
Lung - Non small cell

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Use of the novel GEN cut biopsy tool in addition to usual conventional radial EBUS biopsy tools . GEN cut tool is a blunt ended thin probe of 1.9mm diameter. This has two inwardly placed very small sharp edges that can shear thin slices of tissue with rotation.
This tool will be introduced through a guide sheath hence improving the safety of the procedure.
The procedure will be performed by a trained bronchoscopist . A bronchoscope is a small flexible tube with a camera at the end of the tube to visualise the windpipes. The tools are introduced through the working channel of this bronchoscope. The procedure will be performed under sedation
Intervention code [1] 299472 0
Diagnosis / Prognosis
Comparator / control treatment
Comparison will be made between the GEN cut biopsy samples and conventional Radial EBUS samples of cytology brush, forceps biopsy and needle aspiration biopsy.
In the conventional sampling method the instruments are introduced through the working channel of the bronchoscope as mentioned previously and biopsies or brushings performed.
Control group
Active

Outcomes
Primary outcome [1] 303770 0
1. Ability to obtain a core biopsy sample that would be suitable for PDL-1 testing. This will be assessed by the study pathologist as to the ability to form a core biopsy from the tissue sample obtained via Gen cut tool and the ability to stain for PDL-1 stain.

Timepoint [1] 303770 0
Each biopsy will be assessed at the end of each procedure for the suitability of PDL-1 testing
It is anticipated that 6 months will be required to complete recruitment of 20 patients
Primary outcome [2] 303771 0
Safety: Composite outcome
1. Pneumothorax: This will be assessed by performing a USS using the M band and sliding sign at the bedside soon after biopsy to check for pneumothorax. If any doubt exist the patient will be sent urgently for a conventional CXR.
2. Bleeding: Following each biopsy the amount of bleeding will be assessed. This is anticipated to be no more than conventional Radial EBUS biopsy bleeding which is negligible and requires only suction.
Timepoint [2] 303771 0
within one hour of the procedure
Secondary outcome [1] 340752 0
Patient comfort level by the 10 point facial expression scale
Timepoint [1] 340752 0
Assessed immediately post procedure

Eligibility
Key inclusion criteria
1. Age 18 or older
2. Able to give consent
3. Has a Peripheral lung lesions noted on CT chest/Chest X ray that require a biopsy
4. Lung lesions should be >1.5 cm
5. Lung lesion should be in the outer half of the lung parenchyma
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Not suitable for flexible bronchoscopy
2. Coagulopathy with INR>1.5 or platelets <100
3. Known pulmonary hypertension with RVSP >40
4. Recent myocardial infarction (within 6 weeks)
5. On anticoagulation or anti-platelets other than aspirin that cannot be stopped for the procedure

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
Not yet recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA
Recruitment hospital [1] 9250 0
Westmead Hospital - Westmead
Recruitment postcode(s) [1] 17912 0
2145 - Westmead
Recruitment outside Australia
Country [1] 9316 0
New Zealand
State/province [1] 9316 0
Auckland

Funding & Sponsors
Funding source category [1] 297843 0
Self funded/Unfunded
Name [1] 297843 0
None
Address [1] 297843 0
None
Country [1] 297843 0
Primary sponsor type
Hospital
Name
Westmead Hospital
Address
Department of Respiratory Medicine,
Cnr of Darcy and Hawkesbury Road
Westmead
NSW 2145
Country
Australia
Secondary sponsor category [1] 296884 0
None
Name [1] 296884 0
Address [1] 296884 0
Country [1] 296884 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298890 0
Western Area Local Helath District Ethics Comitte
Ethics committee address [1] 298890 0
Ethics committee country [1] 298890 0
Australia
Date submitted for ethics approval [1] 298890 0
15/09/2017
Approval date [1] 298890 0
04/12/2017
Ethics approval number [1] 298890 0

Summary
Brief summary
The aim of this study is to assess the diagnostic ability and safety in obtaining a core biopsy from peripheral lung lesions (PPL) using the novel Gen Cut tool with Radial EBUS.

Who is it for?
You may be eligible to join this study if you are aged 18 years or over and a have a peripheral lung lesions noted on CT chest/Chest X ray that require a biopsy.

Study details

Procedure: Informed consent will be taken for the procedure from the patient. Procedure will be performed under conscious sedation or general anaesthesia according to the institution.
Once the patient is sedated, the bronchoscope "camera" is introduced via the mouth/nose to the required location. Then a thin USS wire called "Radial EBUS" will be introduced to locate the lesion.
Following this the Gen cut biopsy tools will be introduced as the first mode of biopsy.


How this study may be beneficial for research/treatment:
ThIs study is exploring the new biopsy method (Gen cut) that is safer and can benefit many patients from this safer procedure at their hospital without requiring to transfer to a very specialised centre.


Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 78578 0
Dr Samantha Herath
Address 78578 0
Department of Respiratory and Sleep Medicine
Westmead Hospital
Cnr of Hawkesbury and Darcy Road
Westmead
NSw2145
Country 78578 0
Australia
Phone 78578 0
+61418343787
Fax 78578 0
Email 78578 0
scherath@yahoo.com
Contact person for public queries
Name 78579 0
Dr Samantha Herath
Address 78579 0
Department of Respiratory and Sleep Medicine
Westmead Hospital
Cnr of Hawkesbury and Darcy Road
Westmead
NSw2145
Country 78579 0
Australia
Phone 78579 0
+61418343787
Fax 78579 0
Email 78579 0
scherath@yahoo.com
Contact person for scientific queries
Name 78580 0
Dr Samantha Herath
Address 78580 0
Department of Respiratory and Sleep Medicine
Westmead Hospital
Cnr of Hawkesbury and Darcy Road
Westmead
NSw2145
Country 78580 0
Australia
Phone 78580 0
+61418343787
Fax 78580 0
Email 78580 0
scherath@yahoo.com

No data has been provided for results reporting
Summary results
Not applicable