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
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
Non-small cell lung cancer (NSCLC) accounts for 75 to 80% of all lung cancers, and is
currently the leading cause of tumor-related deaths (1). Optimal lung cancer treatment
relies on accurate disease staging, which is based on tumor size and extent, regional nodal
involvement, and the presence of metastasis. Although thoracic CT has been considered the
standard modality of choice for assessing intrathoracic spread of lung cancer (2), no
consensus has been reached concerning metastasis evaluation. [18F]-fluorodeoxyglucose
(FDG)-positron emission tomography (PET) was introduced and developed as an integrated
modality for accurate nodal staging and for metastatic lesion detection in the whole body
(WB) (3-9). Currently, integrated PET/CT, by providing both morphologic and metabolic
features, appears to have achieved better efficacy in staging lung cancer than CT alone or
PET alone (8, 10).
Whole body magnetic resonance imaging (WB MRI) has become feasible and enables fast scan
throughout the body (11-13). This technique is based on a real-time gradient-echo imaging
and sliding table platform (rolling table concept, which eliminates time-consuming
repositioning of patients and surface coils). MRI scanners of the latest generation use high
field MRI units of > 1.5 Tesla (T), and are reported to have upgraded capabilities in terms
of temporal and spatial resolution due to improved signal-to-noise ratios (SNRs) under high
magnetic-field strength conditions (14, 15).
Because both integrated PET/CT and WB MRI can provide WB imaging, both modalities are used
for staging in patients with a malignant condition. According to a report (16), the
diagnostic efficacy of PET/CT is superior to WB MRI for T and N staging and similar to WB
MRI for detecting metastases. However, according to another study (17), WB MRI showed better
sensitivity than PET/CT for detecting metastatic lesions. In these studies (16, 17), in
which a 1.5T MR unit was used, the regional nodal or metastatic lesions were from various
types of primary malignancies with a wide range of tumor stages.
Recently we published a paper regarding the diagnostic efficacy comparison for determining
TNM stages of integrated PET/CT and 3T WB MRI in patients with an NSCLC (18). In this study,
we found that both PET/CT and 3T whole body MRI appear to provide acceptable accuracy and
comparable efficacy for non-small cell lung cancer staging, but in M stage determination,
each modality has its own advantages. Namely, WB MRI is more useful for detecting brain and
hepatic metastases, whereas PET/CT for lymph node and soft-tissue metastases. Therefore, we
suggested whole body MR/PET should be the future imaging modality for NSCLC staging
especially for M staging.
Although PET/CT scanners have quickly become established, development of MRI/PET has been
slower, due to the additional challenge of developing dual-modality systems that avoid
deleterious interactions caused by the high magnetic field environment of the MRI scanner
and radiofrequency (RF) interference between the PET and MRI systems. At this moment,
MRI/PET is still under development and is used only in small animal study (19). Thus, the
purpose of this research is to provide clinical corroborating data to show how effective
future MRI/PET will be in human use especially in patients with NSCLC by providing the
efficiency of side-by-side reading of WB MRI/PET as compared to PET/CT.
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