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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2016-00571 | Registry Identifier | NCI CTRP Clinical Trial Registry |
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This clinical trial studies how well endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) after positron emission tomography/computed tomography (PET/CT) scan works in diagnosing patients with stage I-IIA non-small cell lung cancer evaluated for stereotactic body radiation therapy (SBRT). Performing EBUS-TBNA after PET/CT scan may help doctors learn more about the accuracy and ways to find early stage lung cancer.
PRIMARY OBJECTIVES:
I. To assess the use of EBUS-TBNA after a PET/CT as a means of improving the accuracy of lymph node staging in patients considered for SBRT.
SECONDARY OBJECTIVES:
I. To assess the usefulness of PET/CT as a diagnostic test in identifying N1 versus N0 staging.
II. To compare survival and recurrence rates in patients with discordant PET/CT and EBUS-TBNA.
III. To describe EBUS-TBNA and SBRT related complications.
OUTLINE:
Patients undergo EBUS-TBNA before SBRT.
After completion of study, patients are followed up at 6 weeks, then every 3 months for the first 2 years then twice a year for the following 3 years, and annually thereafter.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EBUS-TBNA | Endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) performed after PET/CT, and before participant receives stereotactic body radiation therapy (SBRT). EBUS-TBNA results compared with the results of PET/CT. A conventional flexible bronchoscopy performed to examine the tracheobronchial tree, followed by a systematic examination of the accessible intra-thoracic lymph nodes using a linear array ultrasound bronchoscope. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) | Procedure | Endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) performed after PET/CT, and before participant receives stereotactic body radiation therapy (SBRT). EBUS-TBNA results compared with the results of PET/CT. |
| Measure | Description | Time Frame |
|---|---|---|
| Lymphnode Staging Accuracy | The use of EBUS-TBNA after a PET/CT as a means of improving the accuracy of lymphnode staging in patients considered for SBRT estimated as the proportion of patients identified concordantly as having N0 disease with both PET/CT and EBUS-TBNA. | 1 day |
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Inclusion Criteria:
Exclusion Criteria:
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M D Anderson Cancer Center
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| Name | Affiliation | Role |
|---|---|---|
| George A. Eapen, MD | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Texas MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
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| Label | URL |
|---|---|
| MD Anderson Cancer Center | View source |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Aug 29, 2022 | Sep 17, 2025 |
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| ICF_000.pdf |
| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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