Lung CancerINSPECTNCT06380361
InvestigatioN of a Smart Probe for Lung lEsion Characterization Using Impedance Technology
A study testing BioSpy System in people with Lung Cancer, run by Sensome at 2 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer
- What is being tested?
- BioSpy System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 28 Mar 2024to 23 Apr 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 18 years
- Subjects with lesions eligible for lung biopsy under general anesthesia.
- Lesion localization:
- Central or proximal lesions ≥ 10 mm in diameter confirmed by imaging (CT scan and/or PET scan) and/or endobronchial visual control; or
- 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.
- Written Informed Consent to participate in the study.
Who cannot join
- Target lesion <10 mm for central and <20 mm for peripheral lesions (as determined on previous imaging)
- Contra-indication to bronchoscopy procedures
- Contra-indication to general anesthesia
- Any subject that is, according to the discretion of the investigator, not eligible for study participation
- Known lactating or confirmation of positive pregnancy test according to site specific standard of care (e.g. test, verbal communication)
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Australia1 site
Royal Brisbane and Women's Hospital
Brisbane, Queensland, 4019
About this study
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.
Read the 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.
- Conditions
- Lung Cancer
- Being tested
- BioSpy System
- Keywords
- Lung cancer, Lung masses, Lung Nodes, Bronchoscopic biopsy
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BioSpy SystemDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| All patients will be allocated to the same study arm. | Experimental | 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. Receives: Device: BioSpy System |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Ability of BioSpy System to Acquire Electrophysiological Measurements in the Relevant Tissues During Bronchoscopic Biopsy.
The primary endpoint was defined as the proportion of patients in which at least one non-anomalous biophysical measurement was obtained by the BSS in the lesion. This endpoint represents the procedural success rate being defined as the BioSpy System obtaining at least one non-anomalous impedance measurement in the lesion during the procedure, divided by the total number of patients in whom BSS was used.
Measured: During the bronchoscopy procedure, up to 79 minutes
Secondary outcomes (2)
The Ability of BioSpy System to Differentiate the Lesion From Healthy Tissue
Electrical impedance measurements were continuously acquired during bronchoscopy using the BioSpy System. The physician annotated time intervals corresponding to sensor contact with suspected lesion tissue and with healthy tissue, using bronchoscopic visualization and imaging guidance.
Impedance data collected within these annotated windows were extracted for analysis. Each window was matched to the corresponding histopathological diagnosis from biopsy samples obtained at the same location.
Machine learning model predictions (lesion vs. healthy) based on the impedance data were compared with the biopsy results to assess diagnostic performance.
Models were evaluated with leave-one-patient-out training: one patient was held for testing while the model trained on the others. This cycle repeated until all patients were tested, and the mean performance across iterations was computed. Mean accurary, mean sensitivity and mean specificity of detecting lesion are reported.
Measured: During the bronchoscopy procedure, up to 79 minutes
The Ability of BioSpy System to Differentiate Various Lesion Types
The BioSpy System's ability to differentiate tumoral, inflamed, necrotic and fibrotic tissues was assessed using continuous electrical impedance measurements recorded during bronchoscopy.
Physicians annotated intervals where the sensor contacted suspected lesion or healthy tissue guided by bronchoscopic visualization and imaging. Impedance data from these annotated windows were extracted and paired with histopathological diagnoses from biopsies taken at the same location.
Due to limitations in available labels, the secondary endpoint was evaluated by training a machine-learning model to distinguish cancer from all other tissue types.
Model performance was assessed with a leave-one-patient-out procedure: one patient was used for testing while the others were used for training, repeating the process until all had been tested.
Mean accuracy, mean sensitivity and mean specificity for cancer detection are reported.
Measured: During the bronchoscopy procedure, up to 79 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2024
- Study start28 Mar 2024
- Primary completion23 Apr 2025
- Study completion23 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Patient with suspected lung cancer coming to the hospital for bronchoscopic biopsy will be selected for this trial.
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sensome
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06380361
- Sponsor's protocol ID
- SEN-ONCO-1
- Acronym
- INSPECT
- Status last verified
- Mar 2026
- First submitted
- 27 Mar 2024
- Last updated
- 21 Apr 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- InvestigatioN of a Smart Probe for Lung lEsion Characterization Using Impedance Technology
- ClinicalTrials.gov ID
- NCT06380361
- Acronym / sponsor ID
- INSPECT / SEN-ONCO-1
- Conditions
- Lung Cancer
- Keywords
- Lung cancer, Lung masses, Lung Nodes, Bronchoscopic biopsy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- SensomeIndustry (pharma, biotech, devices)
- Study start
- 28 Mar 2024 (actual)
- Primary completion
- 23 Apr 2025 (actual)
- Study completion
- 23 Apr 2025 (actual)
- First posted
- 23 Apr 2024 (actual)
- Results
- Posted 21 Apr 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Patient with suspected lung cancer coming to the hospital for bronchoscopic biopsy will be selected for this trial.
| Arm | Type | Receives |
|---|---|---|
| All patients will be allocated to the same study arm. | Experimental | Device: BioSpy SystemDuring 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age > 18 years
- Subjects with lesions eligible for lung biopsy under general anesthesia.
- Lesion localization:
- Written Informed Consent to participate in the study.
Key exclusion criteria (5 listed)
- Target lesion <10 mm for central and <20 mm for peripheral lesions (as determined on previous imaging)
- Contra-indication to bronchoscopy procedures
- Contra-indication to general anesthesia
- Any subject that is, according to the discretion of the investigator, not eligible for study participation
- Known lactating or confirmation of positive pregnancy test according to site specific standard of care (e.g. test, verbal communication)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BioSpy SystemOne 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. | Device | All patients will be allocated to the same study arm. |
Primary outcome
The Ability of BioSpy System to Acquire Electrophysiological Measurements in the Relevant Tissues During Bronchoscopic Biopsy.
Time frame: During the bronchoscopy procedure, up to 79 minutes
The primary endpoint was defined as the proportion of patients in which at least one non-anomalous biophysical measurement was obtained by the BSS in the lesion. This endpoint represents the procedural success rate being defined as the BioSpy System obtaining at least one non-anomalous impedance measurement in the lesion during the procedure, divided by the total number of patients in whom BSS was used.
2 secondary outcomes
The Ability of BioSpy System to Differentiate the Lesion From Healthy Tissue
Time frame: During the bronchoscopy procedure, up to 79 minutes
The Ability of BioSpy System to Differentiate Various Lesion Types
Time frame: During the bronchoscopy procedure, up to 79 minutes
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Apr 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BioSpy System in people with Lung Cancer, run by Sensome at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Australia, France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Apr 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Ability of BioSpy System to Acquire Electrophysiological Measurements in the Relevant Tissues During Bronchoscopic Biopsy. (time frame: During the bronchoscopy procedure, up to 79 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2026.