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Endobronchial Ultrasound-guided Transbronchial Needle Aspiration for Lymph Node Staging in Patients With Non-small Cell Lung Cancer Pursuing Stereotactic Body Radiotherapy (SBRT)


N/A
18 Years
N/A
Open (Enrolling)
Both
Lung Cancer

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Trial Information

Endobronchial Ultrasound-guided Transbronchial Needle Aspiration for Lymph Node Staging in Patients With Non-small Cell Lung Cancer Pursuing Stereotactic Body Radiotherapy (SBRT)


Patients with radiologically early stage lung cancer who are candidates for SBRT will be
enrolled in this study. Prior to enrollment, patients are required to be evaluated by an
experienced thoracic surgeon, radiation oncologist or medical oncologist to determine
operability. Patients will udergo computed tomography (CT) and positron emission tomography
(PET) prior to EBUS- TBNA. EBUS-TBNA will be performed at the Interventional Thoracic
Surgery Suite (ITSS) located at Toronto General Hospital by a Thoracic Surgeon. The
procedure will be performed under local anesthesia with conscious sedation. Mediastinal as
well as hilar lymph nodes will be assessed by EBUS-TBNA. The result of pathological
diagnosis using EBUS-TBNA will be compared with the result of radiological staging (CT and
PET-CT). Patients who are negative for mediastinal lymph node metastasis by EBUS-TBNA will
undergo SBRT. In addition, the treatment outcome will be evaluated based on the clinical
chart review.


Inclusion Criteria:



1. Age 18 years or older

2. Patients with confirmed lung cancer who require EBUS-TBNA as part of their staging
investigations of the mediastinum and hilum prior to SBRT

3. Performance status score (WHO/ECOG) of 0-2.

4. Cytological or histological proof of non-small cell cancer

5. Stage T1-2 disease, with no evidence of distant metastasis

6. Patients are screened by both computed tomography (CT) and positron emission
tomography (PET)

7. Medically inoperable for surgical resection

8. Patients who refused surgery

Exclusion Criteria:

1. Patients who are deemed on clinical grounds not to be medically fit for a
bronchoscopy

2. Active systemic, pulmonary, or pericardial infection

3. Patients who are pregnant or lactating

4. Patients with plans to receive conventional radiotherapy, chemotherapy, biological
therapy, vaccine therapy, or surgery as treatment (except at disease progression).

5. Inability to give informed consent

Type of Study:

Interventional

Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

To test whether or not there is a difference in accuracy between CT/PET and the minimally invasive technique of EBUS-TBNA for mediastinal staging in patients with non-small cell lung cancer prior to stereotactic body radiotherapy (SBRT).

Outcome Description:

Primary objective: To test whether or not there is a difference in accuracy between CT/PET and the minimally invasive technique of EBUS-TBNA for mediastinal staging in patients with non-small cell lung cancer prior to stereotactic body radiotherapy (SBRT). In comparing EBUS-TBNA vs. CT/PET the primary outcome measures will be: 1) Sensitivity, 2) Specificity, 3) Positive predictive value, 4) Negative predictive value, 5) Accuracy in detecting malignancy

Outcome Time Frame:

3 years

Safety Issue:

No

Principal Investigator

Kazuhiro Yasufuku, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

UHN

Authority:

Canada: UHN Research Ethics Board

Study ID:

12-5294-CE

NCT ID:

NCT01786590

Start Date:

February 2013

Completion Date:

Related Keywords:

  • Lung Cancer
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

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