Implantation of Markers for the Radiotherapy of Lung Cancer Patients
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Lung Cancer
- Sponsor
- Virginia Commonwealth University
- Enrollment
- 6
- Locations
- 1
- Primary Endpoint
- Positional reliability of markers
- Status
- Terminated
- Last Updated
- 12 years ago
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Positional reliability of markers
Time Frame: Up to 5 years
Number of dropped markers
Time Frame: up to 5 years
Visibility of markers on CT and x-rays
Time Frame: up to 5 years
Marker misplacements
Time Frame: up to 5 years
Implantation-related side effects
Time Frame: up to 5 years
Usability for patient treatment
Time Frame: up to 5 years