Non-small Cell Lung Carcinoma Clinical Trial
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
The purpose of the study is to qualify, independently, tumor cell proliferation by 3'-Deoxy-3'-[18F]Fluorothymidine (FLT) -Positron Emission Tomography , and cell death by Diffusion Weighted Imaging (DWI) -Magnetic Resonance Imaging (MRI) compared to pathological quantification (% of viable tumor cells) of the primary tumor after pre-operative chemotherapy in patients with operable Non Small Cell Lung Cancer (NSCLC).
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.
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Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science
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