Marker Guided Breathhold Radiotherapy in NSCLC

Non-Small Cell Lung Cancer Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02447900
• Other study ID #: 310-01
• Status: Completed
• Phase: Phase 1
• Start date: July 2014
• Est. completion date: June 2020

Study information

• Verified date: January 2021
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: June 2020
• Est. primary completion date: June 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-Small Cell Lung Cancer

Intervention

Device:
• BioXmark

Locations

Country	Name	City	State
Denmark	Rigshospitalet, Denmark	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Steen Riisgaard Mortensen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	3 months
Primary	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	0-1 week after placement of gel