Marker Guided Breathhold Radiotherapy in NSCLC

Phase 1

Completed

• Conditions: Non-Small Cell Lung Cancer
• Interventions: Device: BioXmark

• Registration Number: NCT02447900
• Lead Sponsor: Steen Riisgaard Mortensen

Brief 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)

Detailed Description

Not available

Study Timeline

• Study Start: 2014-07
• Study First Submitted: 2015-05-12
• Study First Submitted QC: 2015-05-14
• Study First Posted: 2015-05-19
• Primary Completion: 2020-06
• Study Completion: 2020-06
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-28
• Last Update Posted: 2021-01-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment	BioXmark	-

Primary Outcome Measures

Name	Time	Method
Visibility of the injected gel marker during the course of radiotherapy delivery	3 months	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)
Number of pneumothoraxes in relation to placement procedure of the gel	0-1 week after placement of gel	Counting number of pneumothoraxes caused in relation to the placement procedure of the gel

Trial Locations

Locations (1)

Rigshospitalet, Denmark; 🇩🇰 Copenhagen, Denmark