Overview

This trial is active, not recruiting.

Condition non-small cell lung cancer
Treatment bioxmark
Phase phase 1
Sponsor Steen Riisgaard Mortensen
Start date July 2014
End date June 2018
Trial size 15 participants
Trial identifier NCT02447900, 310-01

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)

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Other)
N/A
bioxmark

Primary Outcomes

Measure
Visibility of the injected gel marker during the course of radiotherapy delivery
time frame: 3 months
Number of pneumothoraxes in relation to placement procedure of the gel
time frame: 0-1 week after placement of gel

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title 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)
Trial information was received from ClinicalTrials.gov and was last updated in May 2015.
Information provided to ClinicalTrials.gov by Rigshospitalet, Denmark.