CompletedPhase 1

Marker Guided Breathhold Radiotherapy in NSCLC

Denmark15 participantsStarted 2014-07

Plain-language 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)

Who can participate

Age range18 Years

SexALL

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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

What they're measuring

Visibility of the injected gel marker during the course of radiotherapy delivery

Timeframe: 3 months

Number of pneumothoraxes in relation to placement procedure of the gel

Timeframe: 0-1 week after placement of gel

Trial details

NCT IDNCT02447900

SponsorSteen Riisgaard Mortensen

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-06

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