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

NCT01065415 | Completed

• 1 other identifier: 2008-07-019
• Study Type: observational
• Target: 272
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Non-small Cell Lung Cancer

Keywords

Magnetic Resonance Imaging/Positron Emission Tomography; Whole body imaging; Non-small cell lung cancer; staging; Diagnostic accuracy

Study Arms (2)

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

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• patients with contraindication for the MR scan such as metalic device or claustrophobia

Sponsors & Collaborators

• Samsung Medical Center: lead

Study Sites (1)

Samsung Medical Center

Seoul, South Korea

Location

Related Publications (1)

• Yi CA, Lee KS, Lee HY, Kim S, Kwon OJ, Kim H, Choi JY, Kim BT, Hwang HS, Shim YM. Coregistered whole body magnetic resonance imaging-positron emission tomography (MRI-PET) versus PET-computed tomography plus brain MRI in staging resectable lung cancer: comparisons of clinical effectiveness in a randomized trial. Cancer. 2013 May 15;119(10):1784-91. doi: 10.1002/cncr.28000. Epub 2013 Feb 19.

  PMID: 23423920 DERIVED

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Kyung Soo Lee, Prof.

  Samsung Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 8, 2010
• First Posted: February 9, 2010
• Study Start: February 1, 2010
• Study Completion: October 1, 2011
• Last Updated: December 29, 2011

Record last verified: 2011-12

Locations

KR (1)