Lung Cancer
Conditions
Keywords
Lung cancer, Lung masses, Lung Nodes, Bronchoscopic biopsy
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.
Interventions
DEVICEBioSpy 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.
Sponsors
Sensome
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Masking description
No masking
Intervention model description
Patient with suspected lung cancer coming to the hospital for bronchoscopic biopsy will be selected for this trial.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Ability of BioSpy System to Acquire Electrophysiological Measurements in the Relevant Tissues During Bronchoscopic Biopsy. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Ability of BioSpy System to Differentiate the Lesion From Healthy Tissue | During the bronchoscopy procedure, up to 79 minutes | 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. |
| The Ability of BioSpy System to Differentiate Various Lesion Types | During the bronchoscopy procedure, up to 79 minutes | 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. |
Countries
Australia, France
Participant flow
Recruitment details
Subjects presenting for bronchoscopic biopsy of lesions suspicious for lung cancer were eligible for study enrollment. Subjects were considered enrolled once the subject had signed and dated the informed consent form as part of the informed consent process.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 69 Years |
| Lesion size | 36 mm |
| Region of Enrollment Australia | 14 Participants |
| Region of Enrollment France | 13 Participants |
| Sex: Female, Male Female | 15 Participants |
| Sex: Female, Male Male | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 27 |
| other Total, other adverse events | 0 / 27 |
| serious Total, serious adverse events | 0 / 27 |
Outcome results
None listed