MRI Optimization Study in Stage III NSCLC

NCT02076282 | Unknown DMC

• 1 other identifier: NL46711.041.13
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Stage III Non-small Cell Lung Cancer

Keywords

Stage III non-small cell lung cancer; Optimization; MRI; Radiotherapy

Outcome Measures

Primary Outcomes (1)

• Optimization and validation of an MRI scanning protocol

  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.

  Healthy volunteers: 1 time point, patients: at start of radiation treatment

Secondary Outcomes (1)

• Power analysis

  Healthy volunteers: one time point, patients: start of radiation therapy

Study Arms (2)

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

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

Interventions

1 MRI scan OTHER

For healthy volunteers: 1 MRI scan without contrast For patients: 1 MRI scan with contrast

Healthy volunteers 1 MRI scan; Patients with stage III NSCLC, 1 MRI scan

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• Healthy volunteers:
• Patients:
• Patients for whom lying still in a supine position for 45 minutes is physically too strenuous (e.g. due to orthopnea).
• Glomerular Filtration Rate (GFR) of \<30 mL/min/1.73m2 (UMCU protocol 'MRI Contra-indicaties', Version 3 January 2013).
• Patients with nephrogenic systemic fibrosis, nephrogenic fibrosing dermopathy or severe renal insufficiency (UMCU protocol 'MRI Contra-indicaties', Version 3 January 2013).

Sponsors & Collaborators

• UMC Utrecht: lead

Study Sites (1)

University Medical Center

Utrecht, Utrecht, 3584CX, Netherlands

RECRUITING

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Marco van Vulpen, MD, PhD

  UMC Utrecht

  PRINCIPAL INVESTIGATOR

Central Study Contacts

David CP Cobben, MD. PhD

CONTACT

+31887557095; d.c.p.cobben@umcutrecht.nl

Astrid LH van Lier, PhD

CONTACT

+31887550284; A.L.H.M.W.vanLier@umcutrecht.nl

Study Design

• Study Type: observational
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: February 25, 2014
• First Posted: March 3, 2014
• Study Start: March 1, 2014
• Primary Completion: November 1, 2015
• Study Completion: November 1, 2015
• Last Updated: February 3, 2015

Record last verified: 2015-02

Locations

NL (1)