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| ID | Type | Description | Link |
|---|---|---|---|
| HM11284 | Other Identifier | VCU IRB | |
| CDR0000630623 | Registry Identifier | PDQ (Physician Data Query) | |
| NCI-2013-00512 | Registry Identifier | CTRP (Clinical Trials Reporting System) |
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Slow accrual
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diagnostic | Experimental | 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| radiation therapy treatment planning/simulation | Radiation | Undergo implantation of radio-opaque markers |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of dropped markers | up to 5 years | |
| Marker misplacements | up to 5 years | |
| Implantation-related side effects | up to 5 years | |
| Visibility of markers on CT and x-rays | up to 5 years | |
| Positional reliability of markers | Up to 5 years | |
| Usability for patient treatment | up to 5 years |
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DISEASE CHARACTERISTICS:
Diagnosis of non-small cell lung cancer
No prior surgical tumor resection
Respiration-induced tumor motion > 5 mm
Recruited by attending physician or research nurse at the Medical College of Virginia Hospitals
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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| Name | Affiliation | Role |
|---|---|---|
| Elisabeth Weiss, MD | Massey Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Virginia Commonwealth University Massey Cancer Center | Richmond | Virginia | 23298-0037 | United States |
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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| implanted fiducial-based imaging | Procedure | Undergo implantation of radio-opaque markers |
|
| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |