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CT‐Controlled Advanced Navigation Techniques for Transbronchial Pulmonary Lesion Access; Evaluation of Electromagnetic Navigation Based Diagnostic Yield (CONTROL-E)

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ClinicalTrials.gov Identifier: NCT03355586
Recruitment Status : Completed
First Posted : November 28, 2017
Last Update Posted : December 17, 2019
Sponsor:
Information provided by (Responsible Party):
Radboud University

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).

Condition or disease Intervention/treatment
Lung Cancer Combination Product: Electromagnetic navigation

Detailed Description:

Lung cancer is one of the leading most frequent types of cancer and is the most lethal malignancy in the Netherlands. Mortality is high due to its advanced stage disease at diagnosis. To improve survival current guidelines are moving towards CT-screening of the high risk population. These CT-scans detect numerous nodules and rapidly increase the demand for minimal invasive accurate and safe diagnostic procedures.

The historically available and current first diagnostic procedure in the work-up of PPLs is fluoroscopy guided Trans Bronchial Biopsy (TBB) despite its low pooled yield of 31.1%. When the above transbronchial technique does not provide an unambiguous outcome, an additional and more invasive diagnostic work-up remains indicated. To exclude the possibility of missing malignancies, trans thoracic needle aspiration is first indicated. If deemed inaccessible, surgical biopsy may be alternatively indicated depending on patient risk of malignancy. Ideally, a transbronchial approach having high diagnostic accuracy would overcome the need of this sequential increasingly invasive diagnostic and consecutive treatment approach. Newer pilot studies now hypothesize that combining multiple new endobronchial modalities might provide a solution in preventing more invasive additional diagnostic staging, reporting diagnostic yields exceeding 70%. When an accurate and certain transbronchial diagnosis by combining multiple techniques can indeed be provided. We will study a combination of new advanced modalities for diagnosis of peripheral nodules endobronchially. The aim of this study is to determine diagnostic yield, cost-effectiveness, safety, and, to collect data for developing diagnostic algorithms to further cost-effectively increase yield, reduce complication rate and determine a future platform for clinical implementation.

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Study Type : Observational
Actual Enrollment : 40 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: CT‐Controlled Advanced Navigation Techniques for Transbronchial Pulmonary Lesion Access; Evaluation of Electromagnetic Navigation Based Diagnostic Yield
Actual Study Start Date : December 21, 2017
Actual Primary Completion Date : January 1, 2019
Actual Study Completion Date : November 1, 2019

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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
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.




Primary Outcome Measures :
  1. number of patients with an adequate diagnosis (= diagnostic yield) [ Time Frame: 0-12 months ]
    diagnosis will consist of benign, malign or non-representative (=blood, anatomical lung tissue, unreachable)


Secondary Outcome Measures :
  1. number of patients with (S)AE's related to the procedure [ Time Frame: 0-12 months ]
    minor bleeding and pneumothoraces are reported

  2. cost-effectiveness [ Time Frame: 0-12 months ]
    the study procedures will be compared against the conventional diagnostic TBB work-up

  3. radiation exposure [ Time Frame: 0-12 months ]
    compared against conventional TBB and consecutive TTNA procedure


Biospecimen Retention:   Samples With DNA
biopsies peripheral nodules


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03355586


Locations
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Netherlands
Radboudumc
Nijmegen, Gelderland, Netherlands, 6525GA
Sponsors and Collaborators
Radboud University
Investigators
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Study Chair: Linda Garms study coordinator
Principal Investigator: Erik van der Heijden, MD PhD Pulmonary diseases
Study Chair: Roel Verhoeven, Msc Pulmonary Diseases / Radiology
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Responsible Party: Radboud University
ClinicalTrials.gov Identifier: NCT03355586    
Other Study ID Numbers: NL63110.091.17
First Posted: November 28, 2017    Key Record Dates
Last Update Posted: December 17, 2019
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by Radboud University:
Lung diseases
Cancer
Interventional pulmonology
Peripheral nodule