Clinical trial NCT04140474: Evaluation of the Archimedes ™ System for Transparenchymatous Access to Pulmonary Nodules.
Official title: Evaluation of the Archimedes ™ System for Transparenchymatous Access to Pulmonary Nodules.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Bronchoscopy
Lung Cancer
Solitary Pulmonary Nodule
Keywords: bronchoscopy
Lung Cancer
Solitary Pulmonary Nodule
Lead sponsor: University Hospital, Limoges
Sponsor class: OTHER
First posted: 2019-10-28
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The aim of this study protocol is to evaluate the feasibility of biopsies using the new system called Archimedes® in 12 patients with solitary pulmonary nodules (SPN) suspicious of malignancy not accessible through current bronchoscopy techniques.

Detailed description: Due to the improvement of screening techniques, the detection of peripheral and isolated lesions is an increasingly frequent situation. However these SPN cause difficulties in obtaining a sample. Indeed, current endoscopic techniques remain insufficient in terms of performance. Moreover, computed tomography-guided percutaneous needle biopsy despite a very good sensitivity has many limitations related to the size of the lesions, the accessibility and important complications. The Archimedes® system is an improved version of LungPoint® and combines 3D reconstruction of chest images with intraoperative radioscopy. It uses a catheter to access through the bronchial wall the pulmonary parenchyma and navigate to the SPN. All included patients will receive anesthesia consultation, biological assessment and chest CT scan in thin sections. A surgical treatment will always be planned after presentation of the file in a meeting of multidisciplinary consultation of thoracic oncology. The Archimedes® procedure will be performed during a bronchoscopy under general anesthesia. Immediate monitoring consisted in a chest x-ray 1hour after the procedure. Patients' participation in the study will stop once they benefit from their thoracic surgery

Eligibility criteria: Inclusion Criteria:

* Patients aged 18 to 75 years with a suspicious nodule of malignancy (primary lung tumor or metastasis of another solid tumor whose largest diameter is greater than or equal to 8 mm):
* Not associated with endobronchial tumor visible during inspection of tracheobronchial tree with soft bronchoscope
* Located in any part of the lung more than 10mm from the pleura
* For which surgical management (atypical resection, lobectomy, bilobectomy or pneumonectomy) is planned after presentation of the file at a multidisciplinary consultation meeting on thoracic oncology of the Investigating Hospital Center
* Patient able to understand the course of the study and giving informed consent
* Affiliate or beneficiary of a social security scheme

Exclusion Criteria:

* Threatening cardiac arrhythmias defined by a rhythm disorder dating discovered less than a month ago
* Myocardial infarction less than one month old
* Hypercapnic respiratory decompensation less than one month old
* coagulopathy
* Thrombocytopenia with platelet count \<100,000 / mm3
* Antecedent (ATCD) of significant bleeding during previous bronchoscopy
* ATCD of pulmonary arterial hypertension (PAH) or suspicion of PAH defined by a measurement of systolic pulmonary arterial pressure greater than 50 mmHg on echocardiography (this examination is not systematic but the suspicion of PAH on the thoracic CT scan leads to other cardiac echocardiographic examinations or right heart catheterization in case of inconclusive ultrasound)
* ATCD of pneumonectomy
* Giant bubble\> 5cm located near the nodule or the tunneling path
* Inability to stop anticoagulant or antiplatelet therapy before the procedure (taking acetylsalicylic acid at any dose is allowed)
* Pregnant or lactating woman
* ATCD for thoracic radiotherapy on the nodule side
* Patient under tutorship or curatorship

Primary outcomes:
measure: Number of diagnostics obtained with the Archimedes system
timeFrame: Month 1
Secondary outcomes:
measure: Scheduling time of the procedure
timeFrame: Day 21
measure: Access time to the nodule
timeFrame: Day 21
measure: Fluoroscopy time
timeFrame: Day 21
measure: Patient registration time
timeFrame: Day 21
measure: morbi-mortality
timeFrame: Month 1
Other outcomes:
Locations:
city: Limoges
country: France
facility: CHU de Limoges
Study officials:
affiliation: University Hospital, Limoges
name: Thomas EGENOD, MD
role: PRINCIPAL_INVESTIGATOR
References: