The primary objective of this study is to correlate the percentage change in apparent diffusion coefficient (ADC) between baseline and early therapy (at day 14) with tumor regression grade (TRG) measured in the surgical resection specimen.
This is a prospective, multicenter, single-arm imaging trial. Patients with resectable liver metastases from colorectal cancer (CRC) will undergo Diffusion Weighted Imaging- Magnetic Resonance Imaging (DWI-MRI) scans at least at three separate occasions: at baseline, at 14 days (maximum +/- 1 days deviation is acceptable) after first administration of chemotherapy and finally after up to 6 cycles of chemotherapy (one week prior to surgery). All patients registered in the study may participate to the test-retest analysis. This analysis required a double baseline scans (called test-retest) to be done on two separate occasions, separated from each other by from one hour to one week but both before start of therapy. The repeated scan at baseline (retest) is optional as it will be used only for the test-retest repeatability analysis. Dedicated in-house developed software will be used to quantify ADC to assess tumor characteristics and response to therapy.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
31
DWI-MRI scans at baseline, at 14 days after first administration of chemotherapy and after up to 6 cycles of chemotherapy
Percentage of ADC changes
Percentage of ADC changes at day 14 relative to baseline
Time frame: at day 14 relative to baseline
Tumor regression grade (TRG)
Tumor regression grade (TRG) in the surgical resection specimen
Time frame: After surgery, up to 22 weeks from baseline
Repeatability Coefficient
Repeatability Coefficient from test-retest ADC measurements at baseline
Time frame: from test-retest ADC measurements at baseline
Pre-operative (post-treatment) ADC measurement
Pre-operative (post-treatment) ADC measurement
Time frame: up to 21 weeks after baseline
Lesion volume
Lesion volume (baseline and, if applicable, after 3 cycles and after 6 cycles) using radiological assessment
Time frame: AT baseline, after 9 weeks and after 18 weeks of chemotherapy
Histopathological measurements of tumor tissue cellularity /density, Necrosis, Proliferation (ki-67)
Histopathological measurements on liver metastases Tumor tissue cellularity/density, Necrosis, Proliferation (ki-67)
Time frame: At baseline and up to 22 weeks after baseline
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