Non-Small Cell Lung Cancer
Conditions
Brief summary
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)
Interventions
DEVICEBioXmark
Sponsors
Steen Riisgaard Mortensen
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age \> 18 years old * Histologically confirmed non-small cell lung cancer (NSCLC) * Stage T1-4N1-3M0 * Performance status ≤ 2 * Inoperable * FEV1 ≥ 1 l * Ability to hold deep inspiration breathhold for \> 15 seconds * Accepting treatment at Rigshospitalet * Eligible for concomitant chemo-radiotherapy * If a woman is of childbearing potential, a negative pregnancy test must be documented * Ability to understand the given information * Signed written consent for inclusion into the study
Exclusion criteria
* Prior thoracic radiotherapy * Allergy to Iodine or iodine based contrast * In the opinion of the investigator, the patient will not be able to follow the study procedures or is considered not eligible for other reasons
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visibility of the injected gel marker during the course of radiotherapy delivery | 3 months | 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) |
| Number of pneumothoraxes in relation to placement procedure of the gel | 0-1 week after placement of gel | Counting number of pneumothoraxes caused in relation to the placement procedure of the gel |
Countries
Denmark
Outcome results
None listed