Marker Guided Breathhold Radiotherapy in NSCLC

Steen Riisgaard Mortensen15 enrolled

Overview

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)

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Non-Small Cell Lung Cancer

Interventions

BioXmarkDEVICE

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Rigshospitalet, Denmark

Copenhagen, Denmark

Outcomes

Primary Outcomes

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

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)

Time frame: 3 months

Number of pneumothoraxes in relation to placement procedure of the gel

Counting number of pneumothoraxes caused in relation to the placement procedure of the gel

Time frame: 0-1 week after placement of gel

Data from ClinicalTrials.gov

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