Implantation of Markers for the Radiotherapy of Lung Cancer Patients

Study Overview
=================
Brief Summary
-----------------
This clinical trial studies imaging markers in planning radiation therapy in patients with lung cancer. Implanting markers in the tumor that can be seen using imaging procedures during radiation therapy may allow x-rays to be sent directly to the tumor and cause less damage to normal tissue.

Detailed Description
-----------------
OBJECTIVES: To acquire experience in the marker implantation process for mediastinal lymph nodes and primary lung tumors in patients with stage I-IIIB non-small cell lung cancer. To characterize the potential side effects involved in the use of markers in these patients. To analyze the positional stability of lung markers in these patients over a radiotherapy series. To acquire experience in the use of markers for treatment planning and radiotherapy in these patients. OUTLINE: Patients undergo implantation of ≥ 1 small radio-opaque Visicoil™ marker into or close to the primary lesion and affected lymph nodes by bronchoscopy. Patients then undergo x-rays to document marker location, detect potentially dropped markers, and diagnose operation-related side effects (i.e., pneumothorax). After marker implantation, patients undergo stereotactic or conventionally fractionated radiotherapy for 30-33 daily fractions.

Official Title
-----------------
Implantation of Markers for the Radiotherapy of Lung Cancer Patients

Conditions
-----------------
Lung Cancer

Intervention / Treatment
-----------------
* Radiation: radiation therapy treatment planning/simulation
* Procedure: implanted fiducial-based imaging


Participation Criteria
=================
Eligibility Criteria
-----------------
DISEASE CHARACTERISTICS: Diagnosis of non-small cell lung cancer Stage I-IIIB disease No prior surgical tumor resection Respiration-induced tumor motion > 5 mm Recruited by attending physician or research nurse at the Medical College of Virginia Hospitals PATIENT CHARACTERISTICS: Not pregnant No insufficient lung function or other parameters prohibiting a bronchoscopy Not a prisoner or institutionalized PRIOR CONCURRENT THERAPY: See Disease Characteristics Concurrent chemotherapy allowed

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Diagnostic<br>Patients undergo implantation of radio-opaque markers into the primary lesion and affected lymph nodes by bronchoscopy. Patients then undergo routine 4D CT, 4D CBCT, fluoroscopy, and x-ray imaging during standard stereotactic radiation therapy (early stage tumors) or conventionally fractionated radiation therapy (advanced stage tumors). | Radiation: radiation therapy treatment planning/simulation<br>* Undergo implantation of radio-opaque markers<br>Procedure: implanted fiducial-based imaging<br>* Undergo implantation of radio-opaque markers<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of dropped markers |  | up to 5 years | 
| Marker misplacements |  | up to 5 years | 
| Implantation-related side effects |  | up to 5 years | 
| Visibility of markers on CT and x-rays |  | up to 5 years | 
| Positional reliability of markers |  | Up to 5 years | 
| Usability for patient treatment |  | up to 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
stage IIIA non-small cell lung cancer, stage IIIB non-small cell lung cancer, stage IA non-small cell lung cancer, stage IB non-small cell lung cancer, stage IIA non-small cell lung cancer, stage IIB non-small cell lung cancer