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Ontwikkeling van een MRI-scanningsprotocol voor het afbeelden van stadium III niet-kleincellig longkanker.

Conditions
1. Healthy volunteers 2. Patients with stage III NSCLC MRI
Registration Number
NL-OMON27984
Lead Sponsor
niversity Medical Center Utrecht
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Pending
Sex
Not specified
Target Recruitment
30
Inclusion Criteria

Healthy volunteers:
o≥18 years.
oWritten informed consent.

Patients:
oPatients with histopathologically or cytologically proven stage III NSCLC (excluding T4N0) referred to the department of Radiation Oncology.
o≥ 18 years.
oWritten informed consent.
oRecent (≤ 21 days) GFR value available

Exclusion Criteria

Healthy volunteers:
oVolunteers who meet exclusion criteria for MRI following the protocol of the departmentof Radiology of the UMC Utrecht.

o Patients:
oPatients who meet exclusion criteria for MRI following the protocol of the department of Radiology of the UMC Utrecht.
oPatients for whom lying still in a supine position for 45 minutes is physically too strenuous (e.g. due to orthopnea).
oGlomerular Filtration Rate (GFR) of <30 mL/min/1.73m2 (UMCU protocol ‘MRI Contra-indicaties’, Version 3 January 2013).
oPatients with nephrogenic systemic fibrosis,nephrogenicfibrosingdermopathy or severe renal insufficiency (UMCU protocol ‘MRI Contra-indicaties’, Version 3 January 2013).

Study & Design

Study Type
Observational non invasive
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
•Healthy volunteers (n=10): Quality of the scans will be assessed by rating the motion artifacts and visibility of the lung and mediastinal parenchyma.<br><br>•Patients with stage III NSCLC (n=20): Optimization of lung MRI for radiotherapy purposes (i.e. tumor delineation and motion characterization) defined by the quality of the images. Quality will be assessed by rating of the scans regarding the visibility of the primary tumor, lymph nodes and mediastinal parenchyma.<br>
Secondary Outcome Measures
NameTimeMethod
- Estimation of number of patients needed to power a study on the added value of MRI for tumor delineation<br>- Estimation of the number of patients needed to power a study on the characterization of tumor and lymph node motion
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