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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Samsung Medical Center
ClinicalTrials.gov Identifier:
NCT01065415
First received: February 8, 2010
Last updated: December 25, 2011
Last verified: December 2011
  Purpose

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

Condition
Non-small Cell Lung Cancer

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
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

Resource links provided by NLM:


Further study details as provided by Samsung Medical Center:

Enrollment: 272
Study Start Date: February 2010
Study Completion Date: October 2011
Groups/Cohorts
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

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.

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

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

Criteria

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01065415

Locations
Korea, Republic of
Samsung Medical Center
Seoul, Korea, Republic of
Sponsors and Collaborators
Samsung Medical Center
Investigators
Principal Investigator: Kyung Soo Lee, Prof. Samsung Medical Center
  More Information

No publications provided by Samsung Medical Center

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Samsung Medical Center
ClinicalTrials.gov Identifier: NCT01065415     History of Changes
Other Study ID Numbers: 2008-07-019
Study First Received: February 8, 2010
Last Updated: December 25, 2011
Health Authority: South Korea: Institutional Review Board

Keywords provided by Samsung Medical Center:
Magnetic Resonance Imaging/Positron Emission Tomography
Whole body imaging
Non-small cell lung cancer
staging
Diagnostic accuracy

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on July 24, 2014