A Phase 1 interventional study of radiation therapy treatment planning/simulation and implanted fiducial-based imaging in Lung Cancer, sponsored by Virginia Commonwealth University. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-12-20.
Sponsored by Virginia Commonwealth University · Phase 1, Interventional, and Treatment
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.
OBJECTIVES:
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.
7,243 studies on the registry are indexed under Lung Neoplasms; 1,558 are open to participants now.
This study's enrollment of 6 is below the median of 60 across 5,296 interventional studies indexed under Lung Neoplasms.
Browse Lung Neoplasms studies →Virginia Commonwealth University is the lead sponsor of 641 studies on the registry; 82 are open to participants now.
Of its 88 completed or terminated interventional studies of FDA-regulated products, 62 (70%) have results posted.
Counted across the registry records on this site, refreshed daily.
DISEASE CHARACTERISTICS:
Diagnosis of non-small cell lung cancer
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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 · Procedure: implanted fiducial-based imaging
Undergo implantation of radio-opaque markers
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
This study is terminated, as verified in Dec 2013. You cannot join it, but the record below documents what was studied.
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Virginia Commonwealth University