MRI Optimization Study in Stage III NSCLC

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by UMC Utrecht
Sponsor:
Information provided by (Responsible Party):
M. van Vulpen, UMC Utrecht
ClinicalTrials.gov Identifier:
NCT02076282
First received: February 25, 2014
Last updated: March 4, 2014
Last verified: March 2014
  Purpose

Radiation therapy uses radiation to treat lung tumors and metastases in the mediastinum. In order to irradiate as precise as possible, and in order to evaluate the effect of radiation treatment, it is important to depict the lung tumor and the lymph node metastases as accurate as possible. Currently, radiation oncologists use PET-CT for this purpose. However, PET-CT does have its drawbacks, and partly because of this, large volumes are irradiated in current treatment.

The investigators believe that MRI can be used to improve depiction of the tumor and lymph nodes and of their motion. However, there is currently no MRI protocol available which is aimed at improving radiotherapy.

In this study, the investigators want to select the optimal MRI settings for depiction of the lung tumor, the lymph node metastases and their movement.

The investigators plan to do this by first examining 10 healthy volunteers, followed by 20 patients with non-small cell lung cancer.


Condition Intervention
Stage III Non-small Cell Lung Cancer
Other: 1 MRI scan

Study Type: Observational
Study Design: Time Perspective: Cross-Sectional
Official Title: MRI for Radiotherapy Treatment Planning of Stage III NSCLC: an MRI Optimization Study in Healthy Volunteers and Patients

Resource links provided by NLM:


Further study details as provided by UMC Utrecht:

Primary Outcome Measures:
  • Optimization and validation of an MRI scanning protocol [ Time Frame: Healthy volunteers: 1 time point, patients: at start of radiation treatment ] [ Designated as safety issue: No ]

    The aim of this study is to optimize and validate an MRI scanning protocol for patients with stage III NSCLC aimed at radiotherapy purposes (i.e. tumor delineation and motion characterization).Optimization is defined by the quality of the images.

    In healthy volunteers, the study endpoint is to select the sequences with the highest quality.

    Quality of the scans will be assessed by rating the motion artifacts and visibility of the lung and mediastinal parenchyma. This will be done by a group of experts (radiologist, radiation oncologist, medical physicist, MRI physicist and a researcher).

    The sequences with the highest quality will be optimized in patients. In patients, the quality will be assessed by rating of the images on the following criteria:

    • Contrast between tumor/lymph nodes and their surrounding tissue.
    • Depiction of tumor, lymph node and mediastinal organ motion.
    • Presence of artifacts.


Secondary Outcome Measures:
  • Power analysis [ Time Frame: Healthy volunteers: one time point, patients: start of radiation therapy ] [ Designated as safety issue: No ]
    The results of this optimization study will be used for the power analysis of consecutive studies.


Estimated Enrollment: 30
Study Start Date: March 2014
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Healthy volunteers 1 MRI scan

Healthy volunteers, recruited at the UMC Utrecht, older than 18, who do not meet the exclusion criteria of the department of Radiology.

Healthy volunteers will receive 1 MRI scan without contrast agent.

Other: 1 MRI scan

For healthy volunteers: 1 MRI scan without contrast

For patients: 1 MRI scan with contrast

Patients with stage III NSCLC, 1 MRI scan

Patients with histopathologically or cytologically proven stage III NSCLC (excluding T4N0), older than 18, with a recent (≤ 21 days) GFR value available

Patients will receive 1 MRI scan with contrast agent.

Other: 1 MRI scan

For healthy volunteers: 1 MRI scan without contrast

For patients: 1 MRI scan with contrast


  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
  • 10 healthy volunteers
  • 20 patients with pathologically proven stage III NSCLC with lymph node metastases (i.e. excluding T4N0) referred to the department of Radiation Oncology.
Criteria

Inclusion Criteria:

  • Healthy volunteers

    1. ≥18 years.
    2. Written informed consent
  • Patients

    1. Patients with histopathologically or cytologically proven stage III NSCLC (excluding T4N0) referred to the department of Radiation Oncology
    2. ≥ 18 years.
    3. Written informed consent.
    4. Recent (≤ 21 days) GFR value available

Exclusion Criteria:

  • Healthy volunteers:

    1. Volunteers who meet exclusion criteria for MRI following the protocol of the department of Radiology of the UMC Utrecht

  • Patients:

    1. Patients who meet exclusion criteria for MRI following the protocol of the department of Radiology of the UMC Utrecht.
    2. Patients for whom lying still in a supine position for 45 minutes is physically too strenuous (e.g. due to orthopnea).
    3. Glomerular Filtration Rate (GFR) of <30 mL/min/1.73m2 (UMCU protocol 'MRI Contra-indicaties', Version 3 January 2013).
    4. Patients with nephrogenic systemic fibrosis, nephrogenic fibrosing dermopathy or severe renal insufficiency (UMCU protocol 'MRI Contra-indicaties', Version 3 January 2013).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02076282

Contacts
Contact: David CP Cobben, MD. PhD +31887557095 d.c.p.cobben@umcutrecht.nl
Contact: Astrid LH van Lier, PhD +31887550284 A.L.H.M.W.vanLier@umcutrecht.nl

Locations
Netherlands
University Medical Center Recruiting
Utrecht, Netherlands, 3584CX
Sub-Investigator: David CP Cobben, MD, PhD         
Sub-Investigator: Emma GG Rutten, MD         
Sub-Investigator: Astrid van Lier, PhD         
Sponsors and Collaborators
UMC Utrecht
Investigators
Principal Investigator: Marco van Vulpen, MD, PhD UMC Utrecht
  More Information

Additional Information:
No publications provided

Responsible Party: M. van Vulpen, MD, PhD, UMC Utrecht
ClinicalTrials.gov Identifier: NCT02076282     History of Changes
Other Study ID Numbers: NL46711.041.13
Study First Received: February 25, 2014
Last Updated: March 4, 2014
Health Authority: Netherlands: Medical Ethics Review Committee (METC)

Keywords provided by UMC Utrecht:
Stage III non-small cell lung cancer
Optimization
MRI
Radiotherapy

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms

ClinicalTrials.gov processed this record on September 18, 2014