Clinical trial NCT06380361: InvestigatioN of a Smart Probe for Lung lEsion Characterization Using Impedance Technology
Official title: InvestigatioN of a Smart Probe for Lung lEsion Characterization Using Impedance Technology
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Lung Cancer
Keywords: Lung cancer
Lung masses
Lung Nodes
Bronchoscopic biopsy
Lead sponsor: Sensome
Sponsor class: INDUSTRY
First posted: 2024-04-23
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Patient with suspected lung cancer coming to the hospital for bronchoscopic biopsy will be selected for this trial.
Primary purpose: OTHER

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.

Detailed description: Participants in this study require a lung biopsy to confirm if they have a lung tumour. A biopsy is a procedure where a piece of lung tissue is removed for testing. Current biopsy techniques cannot guarantee the exact location of lung tumours, so biopsies can be taken from healthy tissue.

The BioSpy System (BSS) is a device with a probe, which is placed inside a normal biopsy needle. The tip of the probe contains sensors, that will scan the composition of the tissue which is in contact with the sensors.

The INSPECT study aims at collecting the sensor data, with the goal of being able to differentiate the different tissues.

All study participants will have a biopsy with the BSS. Participants will have a hospital visit for the procedure, and will have to stay up to 16 hours after their procedure as per normal hospital practice.

Eligibility criteria: 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.

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)

Primary outcomes:
measure: The ability of BioSpy System to acquire electrophysiological measurements in the relevant tissues during bronchoscopic biopsy.
timeFrame: During the bronchoscopic biopsy procedure
Secondary outcomes:
measure: The ability of BioSpy Sysem to differentiate the lesion from healthy tissue
timeFrame: During the bronchoscopic biopsy procedure
measure: The ability of BioSpy Sysem to differentiate various lesion types
timeFrame: During the procedure
Other outcomes:
Locations:
city: Brisbane
country: Australia
facility: Royal Brisbane and Women's Hospital
state: Queensland
city: Le Plessis-Robinson
country: France
facility: Marie-Lannelongue Hospital
Study officials:
References: