Clinical trial · Interventional
The LungVision Navigational Platform for Preoperative Labeling of Pulmonary Ground Glass Nodules With Fiducial Markers
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Based on current evidence, there are no studies investigating the possibility of placing a fiducial marker using augmented fluoroscopy, particularly for partially solid lesions that are often not visible on traditional fluoroscopy. The study in question could provide evidence that will allow, in the future, the use of the LungVision system and radial ultrasound to effectively mark a lesion with a ground glass component highly suspected of malignancy via bronchoscopy, avoiding more invasive marking procedures such as trans-thoracic marking. Correct marking of the target lesion will allow easy identification of the lesion during surgery and its complete removal through small resections, obtaining a definitive histological diagnosis and, in some cases, radical oncological treatment with preservation of healthy lung tissue.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bronchoscopy with Lung Vision navigation system | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Bronchoscopy with Lung Vision navigation system
- description
- Augmented fluoroscopy will be used as a guidance tool, which is already in use at our operating unit as part of normal clinical practice, and will be combined with radial ultrasound using a mini probe. Once the peripheral lesion has been located, a cytological and histological sample will be taken using a needle and/or forceps and/or cryoprobe under augmented fluoroscopic guidance and with R-EBUS, as per normal current clinical practice. If atypical cells or malignant tumour cells are found during the extemporaneous cytological examination, the FM, acquired specifically for the study, will be positioned to mark the pulmonary nodule. A coil-tailed FM will be used. Enhanced fluoroscopy will be used via the LungVision system.
- interventionNames
- Device: Bronchoscopy with Lung Vision navigation system
Primary outcomes (4)
- measure
- Visualisation (%) of the displacement catheter at the target lesion after 3D reconstruction by the LungVision system software
- timeFrame
- During the bronchoscopy procedure
- description
- Investigate the possibility of reaching the target lung lesion with a fiducial marker displacement catheter, using the Lung Vision System's 'tool in lesion' feature as verification.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age ≥ 18 years; * Evidence of a partially solid peripheral pulmonary nodule with a solid component ≥ 6 mm or increasing in size, even if smaller, with a bronchus sign or adjacent bronchus on chest CT; * Obtaining the patient's informed consent. Exclusion Criteria: * Pregnancy or suspected pregnancy; * Contraindication to performing bronchoscopy under deep sedation, based on the anesthesiologist's assessment; * Patient not eligible for surgery due to high surgical risk, based on the anesthesiologist's assessment.
References
Publications (0)
Data not yet available