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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BioSpy System | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | During the bronchoscopy procedure, up to 79 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Age > 18 years
Subjects with lesions eligible for lung biopsy under general anesthesia.
Lesion localization:
Written Informed Consent to participate in the study.
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Royal Brisbane and Women's Hospital | Brisbane | Queensland | 4019 | Australia | ||
| Marie-Lannelongue Hospital |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Two participants were considered screen failures at the end of their baseline visit. One participant withdrew his consent.
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment Group | One arm only - in all eligible study patients, the study device will be used |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Count of Participants | Participants | During the bronchoscopy procedure, up to 79 minutes |
|
From the moment the bronchoscopy procedure begins and the study device is used, until the end of the 24 hours follow-up.
The investigator assessed the causality of all AEs in relation to the research, i.e., the relationship between the AE / SAE and:
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Treatment Group | Adverse Events was collected in treated patients only, i.e. patients in whom the BioSpy System went through the bronchoscope. In total, 27 patients were treated with the study device. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Julie Lafaurie | SENSOME | +33 1 85 37 07 70 | julie@sensome.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol: Version 4 of the CIP, approved in France | Jul 4, 2024 | Feb 16, 2026 | Prot_000.pdf |
| Prot | Yes | No | No | Study Protocol: Version 1 of the CIP, approved in Australia | Dec 14, 2023 | Feb 16, 2026 | Prot_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Mar 7, 2025 | Feb 16, 2026 | SAP_002.pdf |
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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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Patient with suspected lung cancer coming to the hospital for bronchoscopic biopsy will be selected for this trial.
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No masking
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|
| 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. | During the bronchoscopy procedure, up to 79 minutes |
| Le Plessis-Robinson |
| 92350 |
| France |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | Participants |
|
| Lesion size | Median | Inter-Quartile Range | mm |
|
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| Secondary | 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. | A window corresponds to one interval of measurements within the same location, annotated by the physician. More than one window could be collected per patient. | Posted | Mean | Standard Error | Percentage | During the bronchoscopy procedure, up to 79 minutes | Annotated windows | Annotated windows |
|
|
|
| Secondary | 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. | A window corresponds to one interval of measurements within the same location, annotated by the physician. More than one window could be collected per patient. | Posted | Mean | Standard Error | Percentage | During the bronchoscopy procedure, up to 79 minutes | Annotated window | Annotated window |
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| 0 |
| 27 |
| 0 |
| 27 |
| 0 |
| 27 |
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| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
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