Comparative Evaluation of MRI and MDCT for the Detection of Metastic Pulmonary Nodules
2 Years
18 Years
Both
Metastatic Pulmonary Nodules
Trial Information
Comparative Evaluation of MRI and MDCT for the Detection of Metastic Pulmonary Nodules
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.
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 exclusion criteria for MRI (e.g. pacemaker, ocular metal, claustrophobia)
- Have any known allergy to one or more of the ingredients in the study contrast
agents; have a history of hypersensitivity to any metals or chelates of gadolinium;
have a history of allergies or bronchial asthma; use beta blockers, have
cardiovascular disease; or have anaphylactic reactions
- Have moderate-to-severe renal impairment (defined as having a GFR/ eGFR < 60 mL/min)
- Have sickle cell anemia
- MRI of the chest requiring sedation or general anesthesia
- Known pregnancy or breast feeding
- Renal failure
- Patient uncooperative during a MRI without sedation or anesthesia (unless already
receiving this for MRI of another body region)
- Children under the age of 2 will not be eligible for intravenous contrast
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Outcome Measure:
MRI sensitivity for the detection of pulmonary nodule(s) greater than 3mm in size (diameter) compared to CT
Outcome Time Frame:
One hour
Safety Issue:
No
Principal Investigator
Paul Babyn, MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
The Hospital for Sick Children
Authority:
Canada: Health Canada
Study ID:
1000010635
NCT ID:
NCT00751920
Start Date:
August 2008
Completion Date:
November 2009
Related Keywords:
- Metastatic Pulmonary Nodules
- Magnetic Resonance Imaging
- Pediatrics
- Multi-Detector Computed Tomography
- Computed Tomography
- Detection
- Lung Neoplasms
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