Non-small Cell Lung CancerNCT01482182
Predictive Value of FDG PET/CT, DWI and DCE-MRI Scans for Non-small Cell Lung Cancer Patients Receiving Chemotherapy
An observational study of Non-small Cell Lung Cancer, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
In this prospective study, the investigators will evaluate and compare the usefulness of functional and volumetric informations obtained by 18F-FDG PET and MRI before and after the palliative chemotherapy with the aim of predicting tumor response and prognosis in patients with advanced Non-small Cell Lung Cancer… 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
- 35 participants
- Where
- 1 siteSouth Korea
- Study dates
- Nov 2011to Jan 2014
- 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: patients with advanced NSCLC
Who may be able to join
- Histologically proven NSCLC
- Newly diagnosed Stage stage IV
- Participant is being considered for the chemotherapy with EGFR TKI as a first line therapy
- At least one measurable primary or other intrathoracic lesion >= 2cm, according to RECIST
- Performance status of 0 to 2 on the ECOG scale
- Age 18 years or older
- Able to tolerable PET/CT and MRI imaging required by protocol
- Able to give study-specific informed consent
Who cannot join
- Pure bronchioloalveolar cell carcinoma histology
- Thoracic radiotherapy, lung surgery or chemotherapy within three months prior to inclusion in the study
- Poorly controlled diabetes
- Prior malignancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prediction of Chemotherapy Response and Patient Prognosis in Non-small Cell Lung Cancer: Dynamic Contrast-enhanced MRI and Diffusion-weighted Imaging Versus Volume-based Parameter of 18F-FDG PET
In this prospective study, the investigators will evaluate and compare the usefulness of functional and volumetric informations obtained by 18F-FDG PET and MRI before and after the palliative chemotherapy with the aim of predicting tumor response and prognosis in patients with advanced Non-small Cell Lung Cancer (NSCLC).
Read the detailed description
Study cohort will undergo PET/CT and MRI scans prior to chemotherapy and after the first chemotherapy cycle. MRI scans include DCE-MRI and DWI. The following parameters will be calculated using these values:
- Metabolic parameters on FDG-PET A. SUV change ratio (SCR) = SUVpost/SUVpre B. MTV change ratio (VCR) = MTVpost/pre C. TLG change ratio = SCR X VCR
- Perfusion parameters on DCE-MRI A. Kep B. K-trans C. ve
- Diffusion parameters on DWI A. Mean ADC B. fDM
- Conditions
- Non-small Cell Lung Cancer
- Keywords
- Non-small cell lung cancer, Diffusion-weighted MRI, 18F-FDG PET, Treatment response, Prognosis
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What is being measured
The primary outcome is the main question the study is designed to answer.
DWI, DCE-MRI, and FDG PET as early predictor for response and prognosis
The primary endpoint of this study is the prediction of one-year overall survival by monitoring the metabolic and functional responses of the tumor following one cycle of chemotherapy.
Measured: one year
Secondary outcomes (2)
Correlation among DWI, DCE-MRI, and FDG PET and relationship with prognosis
Correlation among metabolic response, functional response on MRI, and standard anatomic response using the RECIST criteria
Measured: one year
Correlation among DWI, DCE-MRI, and FDG PET and relationship with prognosis
(i) the correlation among metabolic response, functional response on MRI, and standard anatomic response using the RECIST criteria (ii) the correlation between functional response (metabolic and MR parameters) and progression-free survival (iii) comparison between the predictive values of FDG-PET and MRI for one-year overall survival.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2011 (estimated)
- Study startNov 2011
- Primary completionNov 2013
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 only
- Time perspective
- Prospective
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Guerbet
- Responsible party
- Sponsor
- Investigators
- Ho Yun Lee, Dr., Principal investigator, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01482182
- Sponsor's protocol ID
- 2011-05-087
- Status last verified
- Oct 2015
- First submitted
- 17 Nov 2011
- Last updated
- 20 Nov 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction of Chemotherapy Response and Patient Prognosis in Non-small Cell Lung Cancer: Dynamic Contrast-enhanced MRI and Diffusion-weighted Imaging Versus Volume-based Parameter of 18F-FDG PET
- ClinicalTrials.gov ID
- NCT01482182
- Acronym / sponsor ID
- 2011-05-087
- Conditions
- Non-small Cell Lung Cancer
- Keywords
- Non-small cell lung cancer, Diffusion-weighted MRI, 18F-FDG PET, Treatment response, Prognosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Collaborators
- Guerbet
- Study start
- Nov 2011
- Primary completion
- Nov 2013 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 30 Nov 2011 (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.
In this prospective study, the investigators will evaluate and compare the usefulness of functional and volumetric informations obtained by 18F-FDG PET and MRI before and after the palliative chemotherapy with the aim of predicting tumor response and prognosis in patients with advanced Non-small Cell Lung Cancer (NSCLC).
Detailed description
Study cohort will undergo PET/CT and MRI scans prior to chemotherapy and after the first chemotherapy cycle. MRI scans include DCE-MRI and DWI. The following parameters will be calculated using these values:
- Metabolic parameters on FDG-PET A. SUV change ratio (SCR) = SUVpost/SUVpre B. MTV change ratio (VCR) = MTVpost/pre C. TLG change ratio = SCR X VCR
- Perfusion parameters on DCE-MRI A. Kep B. K-trans C. ve
- Diffusion parameters on DWI A. Mean ADC B. fDM
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with advanced NSCLC
Key inclusion criteria (8 listed)
- Histologically proven NSCLC
- Newly diagnosed Stage stage IV
- Participant is being considered for the chemotherapy with EGFR TKI as a first line therapy
- At least one measurable primary or other intrathoracic lesion >= 2cm, according to RECIST
- Performance status of 0 to 2 on the ECOG scale
Key exclusion criteria (4 listed)
- Pure bronchioloalveolar cell carcinoma histology
- Thoracic radiotherapy, lung surgery or chemotherapy within three months prior to inclusion in the study
- Poorly controlled diabetes
- Prior malignancy
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
DWI, DCE-MRI, and FDG PET as early predictor for response and prognosis
Time frame: one year
The primary endpoint of this study is the prediction of one-year overall survival by monitoring the metabolic and functional responses of the tumor following one cycle of chemotherapy.
2 secondary outcomes
Correlation among DWI, DCE-MRI, and FDG PET and relationship with prognosis
Time frame: one year
Correlation among DWI, DCE-MRI, and FDG PET and relationship with prognosis
Time frame: one year
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 20 Nov 2015.
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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.
Ho Yun Lee, Dr. 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 8 inclusion and 4 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 20 Nov 2015. 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.
What does the primary outcome measure?
DWI, DCE-MRI, and FDG PET as early predictor for response and prognosis (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Nov 2015.