CT-Controlled Advanced Navigation Techniques for Transbronchial Pulmonary Lesion Access; Evaluation of Electromagnetic Navigation Based Diagnostic Yield

NCT03355586 | Completed DMC FDA Device

• 1 other identifier: NL63110.091.17
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

In this clinical trial we will investigate the diagnostic yield of a combination of commercially available imaging and navigation techniques for reaching peripheral lung lesions. The two investigated techniques will herein be the rEBUS imaging modality combined with electromagnetic based navigation. Confirmation of reaching the lung lesion will be by means of CT (fluoroscopic) imaging. Rapid On-Site Evaluation (ROSE) of cytopathology will be used for obtaining a per-procedural outcome on tissue biopsy representativeness. All data will be prospectively collected. In case tissue biopsy is found to be malignant or benign, it will be termed representative. In case tissue biopsy is found to be non-representative (=blood, anatomical lung tissue, unreachable), conventional followup of CT guided TTNA, follow-up monitoring and/or surgical biopsy will serve as golden standard for obtaining tissue diagnosis. For verification of reaching the target lesion, another study parameter of interest, (cb)CT imaging will be performed for verification that instruments are within the nodule (per-procedurally available).

Conditions

Lung Cancer

Keywords

Lung diseases; Cancer; Interventional pulmonology; Peripheral nodule

Outcome Measures

Primary Outcomes (1)

• number of patients with an adequate diagnosis (= diagnostic yield)

  diagnosis will consist of benign, malign or non-representative (=blood, anatomical lung tissue, unreachable)

  0-12 months

Secondary Outcomes (3)

• number of patients with (S)AE's related to the procedure

  0-12 months

• cost-effectiveness

  0-12 months

• radiation exposure

  0-12 months

Study Arms (1)

Suspected lung cancer

* Patients referred as part of a first diagnostic evaluation of newly detected pulmonary lesion(s) or when an indication for an invasive diagnostic procedure is found during follow-up of earlier detected pulmonary lesion. * Patients identified during per protocol CT imaging follow-up of known lesions when growth of the lesion is found and an indication for biopsy is determined by the treating physician and/or multidisciplinary board. * Patients identified when referred for surgical biopsy in case of nodule location inaccessible for CT-guided TTNA. These will be subjected to a combined approach of modalities with the main intervention being electromagnetic navigation.

Combination Product: Electromagnetic navigation

Interventions

Electromagnetic navigation COMBINATION_PRODUCT

Electromagnetic navigation combined with use of radial EBUS probe and Rapid On Site Evaluation of Histology for diagnosis of peripheral pulmonary nodules.Controlled by cone beam CT.

Suspected lung cancer

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will consist of patients diagnosed with peripheral pulmonary lesion(s) and an indication to obtain a tissue sample(s) following current conventional procedure work-up. In all patients, preprocedural imaging (including CT and/or PET-CT findings) following conventional work-up is available. Case selection for the clinical indication to perform a peripheral pulmonary biopsy (non-surgical and/or surgical) will follow current local clinical practice, multidisciplinary tumor board decisions and is in accordance to the latest British Thoracic Society guidelines (British Thoracic Society Pulmonary Nodule Guideline Development Group, 2015). Patients are eligible after informed consent is obtained and when direct contra-indications for the endobronchial procedure are absent.

You may qualify if:

• In order to be eligible to participate in this study, a subject must meet all of the following criteria:
• ASA physical status 1-3.
• Age 18 years or older.
• A pulmonary lesion (i.e. a focal, rounded opacity mostly surrounded by aerated lung or a ground glass opacity or part- or sub-solid lesion) with an indication for diagnostic evaluation following current clinical guidelines and/or as decided by multi-disciplinary team consultation.

You may not qualify if:

• A potential subject who meets any of the following criteria will be excluded from participation in this study:
• Bleeding disorders.
• Less than 18 years old.
• Contra-indication for temporary interruption of the use of anticoagulant therapy (acenocoumarol, warfarin, therapeutic dose of low molecular weight heparines, clopidrogel, analogs, or, NOAC's).
• Known allergy for lidocaine.
• Uncontrolled pulmonary hypertension.
• Recent and/or uncontrolled cardiac disease.
• Compromised upper airway (e.g. concomitant head and neck cancer or central airway stenosis for any reason such that endobronchial access is considered unsafe).
• ASA classification greater than or equal to 4 (unfit for performing non-surgical biopsy).
• Pregnancy.
• Inability to consent.

Sponsors & Collaborators

• Radboud University Medical Center: lead

Study Sites (1)

Radboudumc

Nijmegen, Gelderland, 6525GA, Netherlands

Location

Biospecimen

Retention: SAMPLES WITH DNA

biopsies peripheral nodules

MeSH Terms

Conditions

Lung Neoplasms; Lung Diseases; Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Respiratory Tract Diseases

Study Officials

• Linda Garms

  study coordinator

  STUDY CHAIR

• Erik van der Heijden, MD PhD

  Pulmonary diseases

  PRINCIPAL INVESTIGATOR

• Roel Verhoeven, Msc

  Pulmonary Diseases / Radiology

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 22, 2017
• First Posted: November 28, 2017
• Study Start: December 21, 2017
• Primary Completion: January 1, 2019
• Study Completion: November 1, 2019
• Last Updated: December 17, 2019

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)