Clinical trial · Interventional
Marker Guided Breathhold Radiotherapy in NSCLC
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)
NCT02447900CI-TRIAL-00049713completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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)
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Non-Small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| BioXmark | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Treatment
- interventionNames
- Device: BioXmark
Primary outcomes (2)
- measure
- Visibility of the injected gel marker during the course of radiotherapy delivery
- timeFrame
- 3 months
- description
- 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)
- measure
- Number of pneumothoraxes in relation to placement procedure of the gel
- timeFrame
- 0-1 week after placement of gel
- description
- Counting number of pneumothoraxes caused in relation to the placement procedure of the gel
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.