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Comparative Evaluation of MRI and MDCT for the Detection of Metastic Pulmonary Nodules

Comparative Evaluation of MRI and MDCT for the Detection of Metastic Pulmonary Nodules

Status
Terminated
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00751920
Enrollment
1
Registered
2008-09-12
Start date
2008-08-31
Completion date
2010-12-31
Last updated
2016-01-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metastatic Pulmonary Nodules

Keywords

Magnetic Resonance Imaging, Pediatrics, Multi-Detector Computed Tomography, Computed Tomography, Detection

Brief summary

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.

Detailed description

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.

Interventions

PROCEDUREEnhanced 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.

Sponsors

The Hospital for Sick Children
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
2 Years to 18 Years
Healthy volunteers
No

Inclusion criteria

* Patients between 2-18 years of age * Patients who present themselves to the Department of Diagnostic Imaging at the Hospital for Sick Children for CT of the thorax * Patients undergoing a CT of the thorax for detection of lung metastases following diagnosis of a solid tumor or suspected solid tumor * Patients who present themselves for initial diagnosis or at follow up CT for progression * Able to give informed consent (parents or patients)

Exclusion criteria

* Usual

Design outcomes

Primary

MeasureTime frame
MRI sensitivity for the detection of pulmonary nodule(s) greater than 3mm in size (diameter) compared to CTOne hour

Secondary

MeasureTime frame
How accurate MRI is at distinguishing between benign and malignant pulmonary nodules.One hour

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026