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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00751920
Recruitment Status : Terminated (The sponsor-investigator relocated to a different institution and was not able to continue the study.)
First Posted : September 12, 2008
Last Update Posted : January 5, 2016
Information provided by (Responsible Party):
The Hospital for Sick Children

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.

Condition or disease Intervention/treatment Phase
Metastatic Pulmonary Nodules Procedure: Enhanced MRI Scan Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Comparative Evaluation of MRI and MDCT for the Detection of Metastic Pulmonary Nodules
Study Start Date : August 2008
Actual Primary Completion Date : November 2010
Actual Study Completion Date : December 2010

Arm Intervention/treatment
Experimental: 1 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.

Primary Outcome Measures :
  1. MRI sensitivity for the detection of pulmonary nodule(s) greater than 3mm in size (diameter) compared to CT [ Time Frame: One hour ]

Secondary Outcome Measures :
  1. How accurate MRI is at distinguishing between benign and malignant pulmonary nodules. [ Time Frame: One hour ]

Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts 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 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00751920

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Canada, Ontario
The Hospital for Sick Children
Toronto, Ontario, Canada
Sponsors and Collaborators
The Hospital for Sick Children
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Principal Investigator: Paul Babyn, MD The Hospital for Sick Children
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Responsible Party: The Hospital for Sick Children Identifier: NCT00751920    
Other Study ID Numbers: 1000010635
First Posted: September 12, 2008    Key Record Dates
Last Update Posted: January 5, 2016
Last Verified: January 2016
Keywords provided by The Hospital for Sick Children:
Magnetic Resonance Imaging
Multi-Detector Computed Tomography
Computed Tomography
Additional relevant MeSH terms:
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Multiple Pulmonary Nodules
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases