Evaluation of FLT-PET and DWI-MRI in Patients With NSCLC Treated With a Platinum-based Doublet as Preoperative Chemo (EVIDENCE)
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|ClinicalTrials.gov Identifier: NCT02273271|
Recruitment Status : Unknown
Verified October 2015 by European Organisation for Research and Treatment of Cancer - EORTC.
Recruitment status was: Recruiting
First Posted : October 23, 2014
Last Update Posted : October 30, 2015
|Condition or disease||Intervention/treatment||Phase|
|Non-small Cell Lung Carcinoma||Other: 18F-FLT-PET/CT and DWI-MRI||Not Applicable|
This is a prospective, multicenter, single-arm imaging trial. Patients with NSCLC will undergo 18F-FLT-PET/CT and DWI-MRI scans on three separate occasions: at baseline, at 14 days (maximum +/- 1 days deviation is acceptable) after first administration of chemotherapy and finally after up to 4 cycles of chemotherapy, and then followed by surgery. The quantification of 18F-FLT SUV and ADC will be measured to assess tumor characteristics and response to therapy.
Patients will be first registered into the EORTC system after signing the informed consent form. The site will have to complete all the study related procedures within 6 weeks prior to treatment and all eligibility criteria should be met before the patient can be enrolled into the study.
Both 18F-FLT-PET/CT and DWI-MRI will be assessed independently in this trial. Therefore the overall type I error of 0.1 will be split by two in order to test independently each imaging biomarker with a one-sided type I error of 0.05. In order to demonstrate with 95% confidence interval (one sided) that the correlation between the imaging biomarker change and the pathological response is > 0.5 (H0: rho ≤ 0.5) with 90% power if the true correlation is 0.8 (H1: rho > 0.5), 31 lesions are needed. As, in this population, patients only have the primary tumor, 31 eligible and evaluable patients will be needed for each primary endpoint.
If all included patients have both 18F-FLT-PET/CT and DWI-MRI then 31 eligible and evaluable patients will be enough. If some patients have only one type of scans (18F-FLT-PET/CT or DWI-MRI), the sample size would need to be adapted to have 31 patients with each type of scans.
In addition, the total number of patients to be registered may be increased to 40 patients for each primary endpoint to take into account some screening failure.
For the primary analysis of correlation between relative change in imaging biomarkers (18F-FLT-SUV or ADC) and pathological quantification, the correlation coefficient will be reported using a one-sided 95% confidence interval, and tested as a one-sided comparison to the null hypothesis (H0: ρ ≤ 0.5). All secondary objectives to correlate preoperative imaging biomarkers and IHC biological markers or tumor volume will use the same analysis as cited above with 99% confidence intervals. All measures will be analyzed in a random effect ANOVA model allowing for within center-variability.
Quality assurance is planned for the control of data consistency, on-site monitoring, audits, and quality assurance in pathological response assessment and in imaging.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||31 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||Evaluation of 3'-Deoxy-3'-[18F]Fluorothymidine -PET and Diffusion Weighted Imaging -MRI in Patients With Early Stage Non-small Cell Lung Cancer Treated With a Platinum-based Doublet as Preoperative Chemotherapy|
|Study Start Date :||October 2015|
|Estimated Primary Completion Date :||December 2016|
|Estimated Study Completion Date :||February 2017|
Experimental: Imaging arm
18F-FLT-PET/CT and DWI-MRI scans at baseline, at 14 days after first administration of chemotherapy and after up to 4 cycles of chemotherapy
Other: 18F-FLT-PET/CT and DWI-MRI
Patients with NSCLC will undergo 18F-FLT-PET/CT and DWI-MRI scans on three separate occasions. Dedicated in-house developed software will be used to quantify 18F-FLT SUV and ADC to assess tumor characteristics and response to therapy.
- Percentage of Apparent Diffusion Coefficient (ADC) change [ Time Frame: day 14 relative to baseline ]Percentage of Apparent Diffusion Coefficient (ADC) change at day 14 relative to baseline
- Percentage of FLT uptake change [ Time Frame: day 14 relative to baseline ]Percentage of FLT uptake change at day 14 relative to baseline
- Pathological quantification (% viable residual tumor cells) [ Time Frame: in average at week 16 from baseline ]participants will receive chemotherapy for up to 12 weeks (4 cycles) and followed by surgery (with an expected surgical preparation of 2-4 weeks)
- Pre-operative (post-treatment) ADC measurement [ Time Frame: in average at week 15 from baseline ]participants will receive chemotherapy for up to 12 weeks (4 cycles) and performed the DWI-MRI scan within one week prior to the surgery
- Pre-operative (post-treatment) FLT uptake measurement [ Time Frame: in average at week 15 from baseline ]participants will receive chemotherapy for up to 12 weeks (4 cycles) and performed the FLT-PET scan within one week prior to the surgery
- Tumor volume (baseline, day 14 and post-treatment) [ Time Frame: baseline, day 14 and post-treatment ]
- Immunohistochemistry (IHC) cell proliferation marker Ki-67 [ Time Frame: 1y ]Immunohistochemistry (IHC) cell proliferation marker Ki-67-index in diagnostic biopsy samples (if available) and surgical specimens.
- Metabolic change from FDG-PET (if available) [ Time Frame: in average at week 9 from baseline ]standard imaging per routine practice
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02273271
|Contact: Oussama Karroumemail@example.com|
|Contact: Leslie Hermanfirstname.lastname@example.org|
|Istituto Clinico Humanitas||Recruiting|
|Milano, Italy, 20089|
|Contact: Arturo Chiti, Medical doctor +39 02 8224 6621 email@example.com|
|Principal Investigator: Arturo Chiti, MD|
|Royal Marsden Hospital - Sutton, Surrey||Recruiting|
|Sutton, United Kingdom|
|Contact: Nandita Desouza, MD +44 2086613289 firstname.lastname@example.org|
|Principal Investigator: Nandita Desouza, MD|
|Sub-Investigator: Sanjay Popat, MD|
|Principal Investigator:||Nandita deSouza||Royal Marsden Hospital - Sutton, Surrey|
|Study Chair:||Sanjay Popat||Royal Marsden Hospital - Chelsea, London|