MedDataX Logo

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

NCT ID: NCT01786590

Last Updated: 2024-12-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-02-28

Study Completion Date

2026-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

It is reported that more than 90,000 patients died of lung cancer and more than 20% of them were older than 80 years in North America. Therefore a less invasive but effective treatment is required for patients with lung cancer of advanced age, diminished pulmonary functions, and chronic diseases. Stereotactic body radiation therapy (SBRT) is an effective and well-tolerated treatment for early stage lung cancer in medically inoperable patients. On the other hand, accurate mediastinal and hilar lymph node staging is one of the most important factors that determine the outcome and indications for SBRT. Endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) is a novel, minimally invasive modality that enables the assessment of mediastinal and hilar lymph nodes with a high sensitivity. Accurate lymph node staging by EBUS-TBNA will allow opportunities for high-risk patients with lung cancer to undergo minimally invasive treatment.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Lung Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

EBUS-TBNA

Group Type EXPERIMENTAL

EBUS-TBNA

Intervention Type PROCEDURE

Currently EBUS-TBNA is performed in patients with CT and/or PET positive lymph nodes in the mediastinum or hilum. In this study, all patients being considered for SBRT will undergo EBUS-TBNA for the lymph node staging prior to SBRT.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

EBUS-TBNA

Currently EBUS-TBNA is performed in patients with CT and/or PET positive lymph nodes in the mediastinum or hilum. In this study, all patients being considered for SBRT will undergo EBUS-TBNA for the lymph node staging prior to SBRT.

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University Health Network, Toronto

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Kazuhiro Yasufuku, MD

Role: PRINCIPAL_INVESTIGATOR

UHN

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Toronto General Hospital

Toronto, Ontario, Canada

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Canada

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Judy McConnell

Role: CONTACT

[email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Judy McConnell, BSc.Hon, CCRP

Role: primary

[email protected]
416-581-7486

Alexandria Grindlay

Role: backup

[email protected]
416-581-7066

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

12-5294-CE

Identifier Type: -

Identifier Source: org_study_id