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

January 4, 2016 updated by: The Hospital for Sick Children
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 Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

1

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada
        • The Hospital for Sick Children

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
MRI sensitivity for the detection of pulmonary nodule(s) greater than 3mm in size (diameter) compared to CT
Time Frame: One hour
One hour

Secondary Outcome Measures

Outcome Measure
Time Frame
How accurate MRI is at distinguishing between benign and malignant pulmonary nodules.
Time Frame: One hour
One hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Hospital for Sick Children

Investigators

  • Principal Investigator: Paul Babyn, MD, The Hospital for Sick Children

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2008

Primary Completion (Actual)

November 1, 2010

Study Completion (Actual)

December 1, 2010

Study Registration Dates

First Submitted

September 10, 2008

First Submitted That Met QC Criteria

September 10, 2008

First Posted (Estimate)

September 12, 2008

Study Record Updates

Last Update Posted (Estimate)

January 5, 2016

Last Update Submitted That Met QC Criteria

January 4, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1000010635

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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