NCT04553809

Brief Summary

Lung cancer is the primary cause of cancer related deaths in Denmark. In order to improve the prognosis diagnosis in earlier stages are needed. This will however require improved sampling techniques from very small lung lesions. One method involves the use of a radial ultrasound probe inserted in the working channel of the bronchoscope, to more accurately identify the lung lesions before sampling them (rEBUS). The other method involves the use of electromagnetic navigation bronchoscopy (ENB) to guide the operator to the lung lesion. This study aims to determine whether a combination of rEBUS and ENB is superior to ENB alone in biopsy sampling. The study will be conducted as a non-blinded RCT. Furthermore, we will make an estimate of the hospital costs of the entire diagnostic work up for lung cancer when combining ENB and rEBUS compared to ENB alone.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P50-P75 for not_applicable lung-cancer

Timeline
Completed

Started Oct 2020

Typical duration for not_applicable lung-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 3, 2020

Completed
14 days until next milestone

First Posted

Study publicly available on registry

September 17, 2020

Completed
25 days until next milestone

Study Start

First participant enrolled

October 12, 2020

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2024

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2025

Completed
Last Updated

May 14, 2025

Status Verified

May 1, 2025

Enrollment Period

3.9 years

First QC Date

September 3, 2020

Last Update Submit

May 8, 2025

Conditions

Lung Cancer

Keywords

lung cancer diagnotics

Outcome Measures

Primary Outcomes (1)

  • Total diagnostic yield

    Total diagnostic yield, being defined as a tissue biopsy allowing a definite diagnosis of either a malignant or benign condition in the lung in proportion to the total number of procedures performed.

    6 months

Secondary Outcomes (10)

  • Malignant diagnostic yield

    6 months

  • Non-malignant diagnostic yield

    6 months

  • Complications

    1 week

  • Severe complications

    1 week

  • Ready to treat

    7 months

  • +5 more secondary outcomes

Study Arms (2)

Kontrol

ACTIVE COMPARATOR

Patients undergoing examination for lung cancer with the use of electromagnetic navigation bronchoscopy for biopsy sampling

Procedure: ENB

Intervention

EXPERIMENTAL

Patients undergoing examination for lunge cancer with the use of electromagnetic navigation bronchoscopy and radial endobronchial ultrasound for biopsy sampling.

Procedure: ENB in combination with rEBUS

Interventions

ENBPROCEDURE

ENB for biopsy sampling of peripheral lung lesion

Kontrol
ENB in combination with rEBUSPROCEDURE

The combination of ENB and rEBUS for biopsy sampling of peripheral lung lesions

Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Examination for lung cancer
  • Peripheral lung lesion or lung nodule surrounded by normal lung parenchyma
  • Written and orally informed consent

You may not qualify if:

  • Patient has medical devices in which ENB is contraindicated (e.g. implanted pacemaker or defibrillator)
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Departement of respiratory medicin

Odense, Region Syddanmark, 5000, Denmark

Location

Related Publications (11)

  • Eberhardt R, Anantham D, Ernst A, Feller-Kopman D, Herth F. Multimodality bronchoscopic diagnosis of peripheral lung lesions: a randomized controlled trial. Am J Respir Crit Care Med. 2007 Jul 1;176(1):36-41. doi: 10.1164/rccm.200612-1866OC. Epub 2007 Mar 22.

    PMID: 17379850BACKGROUND

  • Brownback KR, Quijano F, Latham HE, Simpson SQ. Electromagnetic navigational bronchoscopy in the diagnosis of lung lesions. J Bronchology Interv Pulmonol. 2012 Apr;19(2):91-7. doi: 10.1097/LBR.0b013e31824dd9a1.

    PMID: 23207349BACKGROUND

  • Zhang W, Chen S, Dong X, Lei P. Meta-analysis of the diagnostic yield and safety of electromagnetic navigation bronchoscopy for lung nodules. J Thorac Dis. 2015 May;7(5):799-809. doi: 10.3978/j.issn.2072-1439.2015.04.46.

    PMID: 26101635BACKGROUND

  • Ali MS, Trick W, Mba BI, Mohananey D, Sethi J, Musani AI. Radial endobronchial ultrasound for the diagnosis of peripheral pulmonary lesions: A systematic review and meta-analysis. Respirology. 2017 Apr;22(3):443-453. doi: 10.1111/resp.12980. Epub 2017 Feb 8.

    PMID: 28177181BACKGROUND

  • Khan KA, Nardelli P, Jaeger A, O'Shea C, Cantillon-Murphy P, Kennedy MP. Navigational Bronchoscopy for Early Lung Cancer: A Road to Therapy. Adv Ther. 2016 Apr;33(4):580-96. doi: 10.1007/s12325-016-0319-4. Epub 2016 Mar 22.

    PMID: 27084723BACKGROUND

  • Herth FJ, Eberhardt R, Becker HD, Ernst A. Endobronchial ultrasound-guided transbronchial lung biopsy in fluoroscopically invisible solitary pulmonary nodules: a prospective trial. Chest. 2006 Jan;129(1):147-50. doi: 10.1378/chest.129.1.147.

    PMID: 16424425BACKGROUND

  • Wang Memoli JS, Nietert PJ, Silvestri GA. Meta-analysis of guided bronchoscopy for the evaluation of the pulmonary nodule. Chest. 2012 Aug;142(2):385-393. doi: 10.1378/chest.11-1764.

    PMID: 21980059BACKGROUND

  • Haas AR, Vachani A, Sterman DH. Advances in diagnostic bronchoscopy. Am J Respir Crit Care Med. 2010 Sep 1;182(5):589-97. doi: 10.1164/rccm.201002-0186CI. Epub 2010 Apr 8.

    PMID: 20378726BACKGROUND

  • Munoz-Largacha JA, Litle VR, Fernando HC. Navigation bronchoscopy for diagnosis and small nodule location. J Thorac Dis. 2017 Mar;9(Suppl 2):S98-S103. doi: 10.21037/jtd.2017.01.57.

    PMID: 28446971BACKGROUND

  • Evison M, Crosbie PA, Morris J, Martin J, Barber PV, Booton R. Can computed tomography characteristics predict outcomes in patients undergoing radial endobronchial ultrasound-guided biopsy of peripheral lung lesions? J Thorac Oncol. 2014 Sep;9(9):1393-7. doi: 10.1097/JTO.0000000000000249.

    PMID: 25122434BACKGROUND

  • Schreiber G, McCrory DC. Performance characteristics of different modalities for diagnosis of suspected lung cancer: summary of published evidence. Chest. 2003 Jan;123(1 Suppl):115S-128S. doi: 10.1378/chest.123.1_suppl.115s.

    PMID: 12527571BACKGROUND

Related Links

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Amanda Dandanell Juul, MD

    Dept. of Respiratory Medicine, Odense University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD, PhD student

Study Record Dates

First Submitted

September 3, 2020

First Posted

September 17, 2020

Study Start

October 12, 2020

Primary Completion

August 30, 2024

Study Completion

March 1, 2025

Last Updated

May 14, 2025

Record last verified: 2025-05

Locations

DK(1)