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

Primary Purpose

Metastatic Pulmonary Nodules

Status

Terminated

Phase

Phase 3

Locations

Canada

Study Type

Interventional

Intervention

Enhanced MRI Scan

About this trial

This is an interventional diagnostic trial for Metastatic Pulmonary Nodules focused on measuring Magnetic Resonance Imaging, Pediatrics, Multi-Detector Computed Tomography, Computed Tomography, Detection

Eligibility Criteria

2 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

The Hospital for Sick Children

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

How accurate MRI is at distinguishing between benign and malignant pulmonary nodules.

Full Information

NCT ID

NCT00751920

First Posted

September 10, 2008

Last Updated

January 4, 2016

Sponsor

The Hospital for Sick Children

1. Study Identification

Unique Protocol Identification Number

NCT00751920

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2016

Overall Recruitment Status

Terminated

Why Stopped

The sponsor-investigator relocated to a different institution and was not able to continue the study.

Study Start Date

August 2008 (undefined)

Primary Completion Date

November 2010 (Actual)

Study Completion Date

December 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

The Hospital for Sick Children

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Metastatic Pulmonary Nodules

Keywords

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

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Phase 3

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

1 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Intervention Type

Procedure

Intervention Name(s)

Enhanced MRI Scan

Intervention Description

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 Measure Information:

Title

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

Time Frame

One hour

Secondary Outcome Measure Information:

Title

How accurate MRI is at distinguishing between benign and malignant pulmonary nodules.

Time Frame

One hour

10. Eligibility

Sex

All

Minimum Age & Unit of Time

2 Years

Maximum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Paul Babyn, MD

Organizational Affiliation

The Hospital for Sick Children

Official's Role

Principal Investigator

Facility Information:

Facility Name

The Hospital for Sick Children

City

Toronto

State/Province

Ontario

Country

Canada

12. IPD Sharing Statement

Learn more about this trial

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

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