Whole-Body Magnetic Resonance Imaging/Positron Emission Tomography (MRI/PET) in the Staging of Non-Small-Cell Lung Cancer (NSCLC)

December 25, 2011 updated by: Samsung Medical Center

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

Study Overview

Status

Completed

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

272

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

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

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patient under the suspicion of lung cancer or Patients with NSCLC proved at pathologic examination

Description

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

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

Cohorts and Interventions

Group / Cohort
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

Collaborators and Investigators

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

Investigators

  • Principal Investigator: Kyung Soo Lee, Prof., Samsung Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

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

February 1, 2010

Study Completion (Actual)

October 1, 2011

Study Registration Dates

First Submitted

February 8, 2010

First Submitted That Met QC Criteria

February 8, 2010

First Posted (Estimate)

February 9, 2010

Study Record Updates

Last Update Posted (Estimate)

December 29, 2011

Last Update Submitted That Met QC Criteria

December 25, 2011

Last Verified

December 1, 2011

More Information

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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