Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06380361




Registration number
NCT06380361
Ethics application status
Date submitted
27/03/2024
Date registered
23/04/2024
Date last updated
24/05/2024

Titles & IDs
Public title
InvestigatioN of a Smart Probe for Lung lEsion Characterization Using Impedance Technology
Scientific title
InvestigatioN of a Smart Probe for Lung lEsion Characterization Using Impedance Technology
Secondary ID [1] 0 0
SEN-ONCO-1
Universal Trial Number (UTN)
Trial acronym
INSPECT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Lung Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lung - Mesothelioma
Cancer 0 0 0 0
Lung - Non small cell
Cancer 0 0 0 0
Lung - Small cell

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - BioSpy System

Experimental: All patients will be allocated to the same study arm. - During the bronchoscopic biopsy procedure, the study device will be entered through the bronchoscope to the level of the lesion. At lesion level, the BioSpy System sensor will make several measurements of the tumors and peripheral lung nodules and masses.


Treatment: Devices: BioSpy System
One arm only - in all eligible study patients, the study device will be used. In patients with suspicion of lung cancer a bronchoscope will be inserted to navigate to the lesion where a biopsy sample will be taken for histology analysis. In the current trial, the device will be used to perform electrophysiological measurements in the lesion during bronchoscopic biopsy procedure.
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
The ability of BioSpy System to acquire electrophysiological measurements in the relevant tissues during bronchoscopic biopsy.
Timepoint [1] 0 0
During the bronchoscopic biopsy procedure
Secondary outcome [1] 0 0
The ability of BioSpy Sysem to differentiate the lesion from healthy tissue
Timepoint [1] 0 0
During the bronchoscopic biopsy procedure
Secondary outcome [2] 0 0
The ability of BioSpy Sysem to differentiate various lesion types
Timepoint [2] 0 0
During the procedure

Eligibility
Key inclusion criteria
1. Age > 18 years
2. Subjects with lesions eligible for lung biopsy under general anesthesia.
3. Lesion localization:

1. Central or proximal lesions = 10 mm in diameter confirmed by imaging (CT scan and/or PET scan) and/or endobronchial visual control; or
2. Peripheral lesions = 20 mm in diameter confirmed by imaging (CT scan and/or PET scan) and/or ultrasound analysis (RP EBUS with central localization of the ultrasound probe) during the procedure.
4. Written Informed Consent to participate in the study.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Target lesion <10 mm for central and <20 mm for peripheral lesions (as determined on previous imaging)
2. Contra-indication to bronchoscopy procedures
3. Contra-indication to general anesthesia
4. Any subject that is, according to the discretion of the investigator, not eligible for study participation
5. Known lactating or confirmation of positive pregnancy test according to site specific standard of care (e.g. test, verbal communication)

Study design
Purpose of the study
Other
Allocation to intervention
Not applicable
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
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
28/03/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/04/2025
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
Royal Brisbane and Women's Hospital - Brisbane
Recruitment postcode(s) [1] 0 0
4019 - Brisbane

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Sensome
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The objective of the study is to evaluate the feasibility of the BioSpy System sensor to differentiate tissues that are encountered during bronchoscopic biopsy of endobronchial tumors and peripheral lung nodules and masses.
Trial website
https://clinicaltrials.gov/study/NCT06380361
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Julie Lafaurie, PhD
Address 0 0
Country 0 0
Phone 0 0
+ 33 1 85 37 07 70
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT06380361