Implantation of Markers for the Radiotherapy of Lung Cancer Patients

Lung Cancer Clinical Trial

Official title: Implantation of Markers for the Radiotherapy of Lung Cancer Patients

Status Terminated

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms

• NCT number: NCT00856427
• Study type: Interventional
• Source: Virginia Commonwealth University
• Status: Terminated
• Phase: Phase 1
• Start date: February 2008
• Completion date: August 2012