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Marker Guided Breathhold Radiotherapy in NSCLC

Primary Purpose

Non-Small Cell Lung Cancer

Status
Completed
Phase
Phase 1
Locations
Denmark
Study Type
Interventional
Intervention
BioXmark
Sponsored by
Steen Riisgaard Mortensen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-Small Cell Lung Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Rigshospitalet, Denmark

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Treatment

Arm Description

Outcomes

Primary Outcome Measures

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)
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

Secondary Outcome Measures

Full Information

First Posted
May 12, 2015
Last Updated
January 28, 2021
Sponsor
Steen Riisgaard Mortensen
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1. Study Identification

Unique Protocol Identification Number
NCT02447900
Brief Title
Marker Guided Breathhold Radiotherapy in NSCLC
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)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
July 2014 (undefined)
Primary Completion Date
June 2020 (Actual)
Study Completion Date
June 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Steen Riisgaard Mortensen

4. Oversight

Data Monitoring Committee
No

5. Study Description

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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Small Cell Lung Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment
Arm Type
Other
Intervention Type
Device
Intervention Name(s)
BioXmark
Primary Outcome Measure Information:
Title
Visibility of the injected gel marker during the course of radiotherapy delivery
Description
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
Title
Number of pneumothoraxes in relation to placement procedure of the gel
Description
Counting number of pneumothoraxes caused in relation to the placement procedure of the gel
Time Frame
0-1 week after placement of gel

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Rigshospitalet, Denmark
City
Copenhagen
Country
Denmark

12. IPD Sharing Statement

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Marker Guided Breathhold Radiotherapy in NSCLC

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