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OpenTrials
Completed

NCT Number: NCT02447900

Marker Guided Breathhold Radiotherapy in NSCLC

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)

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Key information

Conditions

Non-small Cell Lung Cancer Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Rigshospitalet, Denmark

Copenhagen, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

BioXmark

Device

Primary outcomes

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

    Time frame: 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)

  2. Number of pneumothoraxes in relation to placement procedure of the gel

    Time frame: 0-1 week after placement of gel

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

Sponsors and collaborators

Lead sponsor

Steen Riisgaard Mortensen

Other

Registry information

Official study 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)

Important dates

Study start
2014
Primary completion
2020
Study completion
2020
First posted
May 19, 2015
Registry last updated
Jan 29, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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