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 range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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

View on ClinicalTrials.gov More Non-Small Cell Lung Cancer trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.