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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00925210
Other study ID # 22176
Secondary ID
Status Completed
Phase Phase 2
First received June 18, 2009
Last updated September 10, 2010
Start date June 2009
Est. completion date September 2010

Study information

Verified date September 2010
Source University of Calgary
Contact n/a
Is FDA regulated No
Health authority Canada: Health Canada
Study type Interventional

Clinical Trial Summary

Patients presenting with solitary or multiple lung nodules often require tissue confirmation in order to guide further management and determine if the lesion is benign or malignant. Several bronchoscopic techniques have emerged which have significantly improved the diagnostic yield of bronchoscopy in this setting, and in particular the combination of peripheral Endobronchial Ultrasonography (pEBUS) and Electromagnetic Navigation Bronchoscopy (ENB) has resulted in diagnostic yields of nearly 90%. In an attempt to reduce the significant cost of this combined approach, the sequential use of pEBUS followed by the more costly ENB technique only if a lesion is not identified on the ultrasound image could be as accurate. This study aims to determine the diagnostic yield of this sequential approach in patients with lung nodule(s).


Recruitment information / eligibility

Status Completed
Enrollment 60
Est. completion date September 2010
Est. primary completion date September 2010
Accepts healthy volunteers No
Gender Both
Age group 16 Years and older
Eligibility Inclusion Criteria:

- Age >16 years

- Lung nodule (s) identified on CT scan

- Clinical decision to obtain tissue biopsy of lung lesion

- CT guided biopsy not preferred technique (previous negative CT guided biopsy or technically difficult nodule location or perceived high risk of pneumothorax or other complications)

- Pleural based lesion only if: Inaccessible by CT guided biopsy or previous CT guided biopsy non-diagnostic

Exclusion Criteria:

- Lack of informed consent

- Nodule less than 1 cm or greater than 6 cm long axis

- Mediastinal adenopathy >2cm short axis on CT chest

- Evidence of endobronchial abnormality on chest CT

- Medical contraindication to bronchoscopy

- Patients with lesions highly suspicious for lung cancer, potentially resectable with lobar or lesser resection and without significantly increased operative risk factors will not be entered into this study prior to surgical evaluation.

- Patient with implanted electronic medical device

- Uncontrolled or irreversible coagulopathy (platelets <100, INR >1.3, use of clopidogrel in the 7 days prior to bronchoscopy)

- Confirmed or suspected pregnancy

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic


Intervention

Procedure:
Sequential pEBUS - ENB
Subject will undergo bronchoscopy with peripheral endobronchial ultrasonography to identify the peripheral lung nodule. If the lesion is identified with pEBUS, samples will be collected. If the lesion is not found by pEBUS, the electromagnetic navigation system will be deployed and directed to the lesion of interest, once again using pEBUS to confirm final location before samples are collected.

Locations

Country Name City State
Canada Foothills Medical Center Calgary Alberta
Canada Institut Universitaire de Cardiologie et de Pneumologie de Quebec Quebec

Sponsors (1)

Lead Sponsor Collaborator
University of Calgary

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary diagnostic yield No
Secondary sensitivity, specificity, positive and negative predictive value No
Secondary Impact of nodule size (<2 cm, 2-3 cm, >3cm) and distribution on diagnostic yield No
Secondary Independent and incremental yield of BAL, biopsy, needle aspiration and brush cytology will be compared No
Secondary Complication rate Yes
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