Marker Guided Breathhold Radiotherapy in NSCLC

Steen Riisgaard Mortensen

Status and phase

Completed

Phase 1

Conditions

Non-Small Cell Lung Cancer

Treatments

Device: BioXmark

Study type

Interventional

Funder types

Other

Identifiers

NCT02447900

310-01

Details and patient eligibility

About

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)

Enrollment

15 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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