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Clinical Trials/NCT00856427
NCT00856427
Terminated
Phase 1

Implantation of Markers for the Radiotherapy of Lung Cancer Patients

Virginia Commonwealth University1 site in 1 country6 target enrollmentFebruary 2008
ConditionsLung Cancer

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.

Registry
clinicaltrials.gov
Start Date
February 2008
End Date
August 2012
Last Updated
12 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

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

Study Sites (1)

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