NCT02447900

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)

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for phase_1 nonsmall-cell-lung-cancer

Timeline
Completed

Started Jul 2014

Longer than P75 for phase_1 nonsmall-cell-lung-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2014

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

May 12, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 19, 2015

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2020

Completed
Last Updated

January 29, 2021

Status Verified

January 1, 2021

Enrollment Period

5.9 years

First QC Date

May 12, 2015

Last Update Submit

January 28, 2021

Conditions

Non-Small Cell Lung Cancer

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Study Arms (1)

Treatment

OTHER
Device: BioXmark

Interventions

BioXmarkDEVICE
Treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rigshospitalet, Denmark

Copenhagen, Denmark

Location

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, BronchogenicBronchial NeoplasmsLung NeoplasmsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

May 12, 2015

First Posted

May 19, 2015

Study Start

July 1, 2014

Primary Completion

June 1, 2020

Study Completion

June 1, 2020

Last Updated

January 29, 2021

Record last verified: 2021-01

Locations

DK(1)