Lung CancerNCT02719847
EBUS TBNA After PET/CT in Diagnosing Patients With Stage I-IIA Non-small Cell Lung Cancer Evaluated for Stereotactic Body Radiation Therapy
An observational study of Lung Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer
- What is being tested?
- Endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA)
- Type of treatment
- Surgery or procedure
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Mar 2016to 12 Sep 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: M D Anderson Cancer Center
Who may be able to join
- Patient must be > 18 years old
- Patient must have proven or suspected non small cell lung cancer (NSCLC) and be clinical Stage I or IIa, according to the 7th edition staging system of the American Joint Commission on Cancer for lung cancer (T1 or T2a, N0 or N1, M0)
- Patient must have a PET/CT obtained within 40 days of having the EBUS-TBNA
- Patient is being considered for SBRT
- Patient or the patient's legally authorized representative must provide written informed consent prior to registration and any study-related procedures
- If the patient is a survivor of a prior invasive cancer, all of the following criteria must apply: a) Patient has undergone potentially curative therapy for all prior malignancies b) No evidence of active / recurrent disease within 5 years
Who cannot join
- Patient has received prior chemotherapy or radiotherapy for this cancer
- Patients already scheduled to receive conventional radiotherapy, chemotherapy, biological therapy, vaccine therapy, or surgery as treatment (except at disease progression)
- Patients malignancy is consistent with well differentiated neuroendocrine (carcinoid) histology
- Patients who are planning to undergo treatment in a different institution
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: Additive Value of EBUS TBNA for Staging Non-Small Cell Lung Cancer in Patients Evaluated for Stereotactic Body Radiation Therapy
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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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:
- 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.
- Conditions
- Lung Cancer
- Being tested
- Endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA)
- Keywords
- Lung cancer, Non-Small Cell Lung, NSCLC, Suspected non small cell lung cancer, Endobronchial ultrasound-guided transbronchial needle aspiration, EBUS-TBNA
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA)Procedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2016 (estimated)
- Study start18 Mar 2016
- Primary completion12 Sep 2025
- Study completion12 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- George A. Eapen, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02719847
- Sponsor's protocol ID
- 2015-0615
- Other IDs
- NCI-2016-00571
- Status last verified
- Sep 2025
- First submitted
- 21 Mar 2016
- Last updated
- 23 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Additive Value of EBUS TBNA for Staging Non-Small Cell Lung Cancer in Patients Evaluated for Stereotactic Body Radiation Therapy
- ClinicalTrials.gov ID
- NCT02719847
- Acronym / sponsor ID
- 2015-0615
- Conditions
- Lung Cancer
- Keywords
- Lung cancer, Non-Small Cell Lung, NSCLC, Suspected non small cell lung cancer, Endobronchial ultrasound-guided transbronchial needle aspiration, EBUS-TBNA
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 18 Mar 2016 (actual)
- Primary completion
- 12 Sep 2025 (actual)
- Study completion
- 12 Sep 2025 (actual)
- First posted
- 25 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
PRIMARY OBJECTIVES:
- 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:
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EBUS-TBNA | – | Procedure: Endobronchial ultrasound-guided transbronchial needle aspiration (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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- M D Anderson Cancer Center
Key inclusion criteria (6 listed)
- Patient must be > 18 years old
- Patient must have proven or suspected non small cell lung cancer (NSCLC) and be clinical Stage I or IIa, according to the 7th edition staging system of the American Joint Commission on Cancer for lung cancer (T1 or T2a, N0 or N1, M0)
- Patient must have a PET/CT obtained within 40 days of having the EBUS-TBNA
- Patient is being considered for SBRT
- Patient or the patient's legally authorized representative must provide written informed consent prior to registration and any study-related procedures
Key exclusion criteria (4 listed)
- Patient has received prior chemotherapy or radiotherapy for this cancer
- Patients already scheduled to receive conventional radiotherapy, chemotherapy, biological therapy, vaccine therapy, or surgery as treatment (except at disease progression)
- Patients malignancy is consistent with well differentiated neuroendocrine (carcinoid) histology
- Patients who are planning to undergo treatment in a different institution
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Endobronchial ultrasound-guided transbronchial needle aspiration (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. | Procedure or surgery | EBUS-TBNA |
Primary outcome
Lymphnode Staging Accuracy
Time frame: 1 day
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2025.
- MD Anderson Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
George A. Eapen, MD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lymphnode Staging Accuracy (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2025.