Implantation of Markers for the Radiotherapy of Lung Cancer Patients

Phase 1

Terminated

• Conditions: Lung Cancer
• Interventions: Radiation: radiation therapy treatment planning/simulation; Procedure: implanted fiducial-based imaging

• Registration Number: NCT00856427
• Lead Sponsor: Virginia Commonwealth University

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.

Study Timeline

• Study Start: 2008-02
• Study First Submitted: 2009-03-04
• Study First Submitted QC: 2009-03-04
• Study First Posted: 2009-03-05
• Primary Completion: 2012-01
• Study Completion: 2012-08
• Status Verified: 2013-12
• Last Update Submitted: 2013-12-18
• Last Update Posted: 2013-12-20

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 6

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Diagnostic	radiation therapy treatment planning/simulation	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).
Diagnostic	implanted fiducial-based imaging	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).

Primary Outcome Measures

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

Trial Locations

Locations (1)

Virginia Commonwealth University Massey Cancer Center; 🇺🇸 Richmond, Virginia, United States