Marker Guided Breathhold Radiotherapy in NSCLC

NCT ID: NCT02447900

Last Updated: 2021-01-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-07-31

Study Completion Date

2020-06-30

Brief Summary

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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

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Conditions

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Non-Small Cell Lung Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment

Group Type OTHER

BioXmark

Intervention Type DEVICE

Interventions

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BioXmark

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Steen Riisgaard Mortensen

OTHER

Sponsor Role lead

Responsible Party

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Steen Riisgaard Mortensen

MD

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Rigshospitalet, Denmark

Copenhagen, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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310-01

Identifier Type: -

Identifier Source: org_study_id

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