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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2008 by The Hospital for Sick Children.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
The Hospital for Sick Children
ClinicalTrials.gov Identifier:
NCT00751920
First received: September 10, 2008
Last updated: NA
Last verified: September 2008
History: No changes posted
  Purpose

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 Intervention Phase
Metastatic Pulmonary Nodules
Procedure: Enhanced MRI Scan
Phase 3

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by The Hospital for Sick Children:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • How accurate MRI is at distinguishing between benign and malignant pulmonary nodules. [ Time Frame: One hour ] [ Designated as safety issue: No ]

Estimated Enrollment: 105
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)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   2 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00751920

Locations
Canada, Ontario
The Hospital for Sick Children Recruiting
Toronto, Ontario, Canada
Contact: Paul Babyn, MD    (416)813-5527    paul.babyn@sickkids.ca   
Principal Investigator: Paul Babyn, MD         
Sub-Investigator: Emma Helm, MD         
Sub-Investigator: Ronald Grant, MD         
Sponsors and Collaborators
The Hospital for Sick Children
Investigators
Principal Investigator: Paul Babyn, MD The Hospital for Sick Children
  More Information

No publications provided

Responsible Party: Paul Babyn/Principal Investigator, The Hospital for Sick Children
ClinicalTrials.gov Identifier: NCT00751920     History of Changes
Other Study ID Numbers: 1000010635
Study First Received: September 10, 2008
Last Updated: September 10, 2008
Health Authority: Canada: Health Canada

Keywords provided by The Hospital for Sick Children:
Magnetic Resonance Imaging
Pediatrics
Multi-Detector Computed Tomography
Computed Tomography
Detection

Additional relevant MeSH terms:
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on April 16, 2014