Non-small Cell Lung CancerNCT01065415
Whole-Body Magnetic Resonance Imaging/Positron Emission Tomography (MRI/PET) in the Staging of Non-Small-Cell Lung Cancer (NSCLC)
An observational study of Non-small Cell Lung Cancer, run by Samsung Medical Center at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Non-small Cell Lung Cancer
- How many people
- 272 participants
- Where
- 1 siteSouth Korea
- Study dates
- Feb 2010to Oct 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient under the suspicion of lung cancer or Patients with NSCLC proved at pathologic examination
Who may be able to join
- 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.
Who cannot join
- patients with contraindication for the MR scan such as metalic device or claustrophobia
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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
Read the 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.
- Conditions
- Non-small Cell Lung Cancer
- Keywords
- Magnetic Resonance Imaging/Positron Emission Tomography, Whole body imaging, Non-small cell lung cancer, staging, Diagnostic accuracy
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2010 (estimated)
- Study startFeb 2010
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Non-small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 272 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kyung Soo Lee, Prof., Principal investigator, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01065415
- Sponsor's protocol ID
- 2008-07-019
- Status last verified
- Dec 2011
- First submitted
- 8 Feb 2010
- Last updated
- 29 Dec 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 23423920
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01065415
- Acronym / sponsor ID
- 2008-07-019
- 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 type
- Observational
- Recruitment status
- Completed
- Enrolment
- 272 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- Feb 2010
- Study completion
- Oct 2011 (actual)
- First posted
- 9 Feb 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient under the suspicion of lung cancer or Patients with NSCLC proved at pathologic examination
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- patients with contraindication for the MR scan such as metalic device or claustrophobia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2011.
- Derived from this study: PubMed 23423920Yi 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kyung Soo Lee, Prof. principal investigator
Samsung Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-small Cell Lung Cancer, run by Samsung Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Dec 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01065415, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2011; AzTrials last refreshed its copy on 8 Nov 2026.