Comparative Evaluation of MRI and MDCT for the Detection of Metastic Pulmonary Nodules
Recruitment status was Recruiting
The purpose of this study is to apply the techniques of dynamic MRI imaging enhancement to research participants with one or more pulmonary nodule to determine if meaningful information about the nature of the nodule can be obtained. This data will then be compared with follow up information about nodule growth or histology obtained by biopsy or surgical resection.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||Comparative Evaluation of MRI and MDCT for the Detection of Metastic Pulmonary Nodules|
- MRI sensitivity for the detection of pulmonary nodule(s) greater than 3mm in size (diameter) compared to CT [ Time Frame: One hour ] [ Designated as safety issue: No ]
- How accurate MRI is at distinguishing between benign and malignant pulmonary nodules. [ Time Frame: One hour ] [ Designated as safety issue: No ]
|Study Start Date:||August 2008|
|Estimated Study Completion Date:||November 2009|
|Estimated Primary Completion Date:||August 2009 (Final data collection date for primary outcome measure)|
Procedure: Enhanced MRI Scan
Following the detection of a pulmonary nodule(s) with the unenhanced MRI scan, the subjects will then be injected with the contrast agent, Magnevist, and have a dynamic enhanced MRI scan of the largest pulmonary nodule.
The gold standard for investigating the detection of pulmonary metastases is Multi-Detector Computed Tomography (MDCT). Computed Tomography (CT) is routinely used in the staging of pediatric patients with primary tumors which commonly metastasize to the lungs (with approximate percentage incidence of pulmonary metastases at presentation) are Ewing's sarcoma (15-20%), osteosarcoma (15-20%), Wilm's Tumor (10%), rhabdomyosarcoma (10%), and hepatoblastoma (10%). However, CT scanning has two central limitations. Firstly, it carries associated radiation risks. This risk is increased if multiple scans need to be performed during treatment and follow up. This is of particular concern in children who frequently have curable disease and may have years to live with the radiation risk. Secondly, CT is limited in its ability to distinguish between benign and malignant nodules.
Recently, Magnetic Resonance Imaging (MRI) of the lung has been shown to be a feasible alternative to CT for the detection of pulmonary metastases in adults with sensitivities and specificities of over 90% for the detection of nodules 5mm or larger. It has also shown promise in the characterization of nodules as benign or malignant. Since MRI does not involve radiation, it may prove to be a preferable imaging technique for children. We wish to evaluate the potential for MRI to complement or even replace CT in the imaging of pulmonary metastatic disease in children.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00751920
|The Hospital for Sick Children||Recruiting|
|Toronto, Ontario, Canada|
|Contact: Paul Babyn, MD (416)813-5527 email@example.com|
|Principal Investigator: Paul Babyn, MD|
|Sub-Investigator: Emma Helm, MD|
|Sub-Investigator: Ronald Grant, MD|
|Principal Investigator:||Paul Babyn, MD||The Hospital for Sick Children|