Non-small Cell Lung Cancer Clinical Trial
Official title:
The Efficacy of Coregistered Whole-Body Magnetic Resonance Imaging/Positron Emission Tomography (MRI/PET) in the Staging of Non-Small-Cell Lung Cancer
Verified date | December 2011 |
Source | Samsung Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | South Korea: Institutional Review Board |
Study type | Observational |
The accurate staging is an essential part for the treatment and prognosis of non-small-cell
lung cancer (NSCLC). Whole body MR imaging proved to be effective in staging of NSCLC as
much as PET/CT. And there were organs of strength for each modality in the detection of
metastasis. Therefore, integrated approach using whole body MR and PET would be more
beneficial for the accurate staging of lung cancer with improved diagnostic efficacies and
reduced radiation exposure.
The aim of this project is to evaluate the diagnostic efficacy of side-by-side reading of
whole-body magnetic resonance imaging/ positron emission tomography (MRI/PET) and to compare
with that of whole-body magnetic resonance imaging (WB MRI) alone and that of integrated
PET/CT in determining the stage of NSCLC.
Patients with pathologically-proven NSCLC will be prospectively enrolled, if they are
considered as surgical candidates for the treatment of lung cancer through conventional
methods of staging, i.e. history taking, physical examination, blood tests, bronchoscopy,
and enhanced chest CT scans. PET/CT will be routinely performed for the staging of lung
cancer in our institution. For the purpose of this study, whole body MRI will be performed
for these patients within 3 days from the date of acquisition of PET/CT. The results of TNM
staging from each modality will be collected prospectively and their efficacies can be
calculated based on the reference standards. Reference standards of T and N staging will be
surgically confirmed. And M staging can be confirmed by biopsy, other imaging modalities, or
follow-up more than 6 months.
Diagnostic efficacies of coregistered MRI/PET can be evaluated with the comparison from the
consecutive two-arm enrollment with random assignment of control group and study group as
follows:
- control group: routine staging work-up with chest CT, PET/CT, and brain MRI
- study group: routine staging work-up plus whole body MRI for Coregistered MRI/PET
Status | Completed |
Enrollment | 272 |
Est. completion date | October 2011 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 20 Years and older |
Eligibility |
Inclusion Criteria: - Patient with solitary pulmonary nodule under the suspicion of lung cancer - Patients with NSCLC proved at pathologic examination will do PETCT as a routine staging work-up. Exclusion Criteria: - patients with contraindication for the MR scan such as metalic device or claustrophobia |
Observational Model: Case Control, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Samsung Medical Center | Seoul |
Lead Sponsor | Collaborator |
---|---|
Samsung Medical Center |
Korea, Republic of,
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