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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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8 February 2021 |
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Main ID: |
NCT02447900 |
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Date of registration:
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12/05/2015 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Marker Guided Breathhold Radiotherapy in NSCLC
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Scientific title:
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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) |
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Date of first enrolment:
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July 2014 |
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Target sample size:
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15 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02447900 |
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Study type:
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Interventional |
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Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 1
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Countries of recruitment
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Denmark
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Key inclusion & exclusion 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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Non-Small Cell Lung Cancer
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Intervention(s)
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Device: BioXmark
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Primary Outcome(s)
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Number of pneumothoraxes in relation to placement procedure of the gel
[Time Frame: 0-1 week after placement of gel]
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Visibility of the injected gel marker during the course of radiotherapy delivery
[Time Frame: 3 months]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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