Implantation of Markers for the Radiotherapy of Lung Cancer Patients
|ClinicalTrials.gov Identifier: NCT00856427|
Recruitment Status : Terminated (Slow accrual)
First Posted : March 5, 2009
Last Update Posted : December 20, 2013
|Condition or disease||Intervention/treatment||Phase|
|Lung Cancer||Radiation: radiation therapy treatment planning/simulation Procedure: implanted fiducial-based imaging||Phase 1|
- 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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||6 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Implantation of Markers for the Radiotherapy of Lung Cancer Patients|
|Study Start Date :||February 2008|
|Primary Completion Date :||January 2012|
|Study Completion Date :||August 2012|
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
Undergo implantation of radio-opaque markersProcedure: implanted fiducial-based imaging
Undergo implantation of radio-opaque markers
- Number of dropped markers [ Time Frame: up to 5 years ]
- Marker misplacements [ Time Frame: up to 5 years ]
- Implantation-related side effects [ Time Frame: up to 5 years ]
- Visibility of markers on CT and x-rays [ Time Frame: up to 5 years ]
- Positional reliability of markers [ Time Frame: Up to 5 years ]
- Usability for patient treatment [ Time Frame: up to 5 years ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00856427
|United States, Virginia|
|Virginia Commonwealth University Massey Cancer Center|
|Richmond, Virginia, United States, 23298-0037|
|Principal Investigator:||Elisabeth Weiss, MD||Massey Cancer Center|