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Proof of concept study evaluating safety and performance of a gel marker (BioXmark) used for image guidance in deep inspiration breathhold radiotherapy (DIBH IGRT) in patients with locally advanced non-small cell lung cancer (NSCLC)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BioXmark | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Visibility of the injected gel marker during the course of radiotherapy delivery | Stability of the geometrical configuration and visibility of the injected gel marker in 2D kV x-rays and CBCT (cone-beam computed tomography) acquired throughout the treatment course and quantified by vectors and contrast to noise ratio (CNR) | 3 months |
| Number of pneumothoraxes in relation to placement procedure of the gel | Counting number of pneumothoraxes caused in relation to the placement procedure of the gel | 0-1 week after placement of gel |
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Inclusion criteria
Exclusion criteria
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rigshospitalet, Denmark | Copenhagen | Denmark |
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
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| D013899 |
| Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |