Dataset Information

Single-center Ambispective Observational Study on the Role of Magnetic Resonance Imaging (MRI) in the Evaluation of Patient Affected by Hepatic Metastases of Carcinoma of the Colorectal Cancer (CRC).

ABSTRACT: This study wants to evaluate the use of MRI in the managemente of mCRC with liver only metastases.

DISEASE(S): Colorectal Cancer,Colorectal Neoplasms

PROVIDER: 66877 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

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Project description:Interventions: FDG-PET, Biomarker testing with optional MRI will be administered to participants eligible and consenting to this study. Patients will receive 5-6 weeks of CRT depending on their staging. FDG- PET scans will be performed at 3 timepoints for all patients. PETpre is to be completed prior to commencement of CRT, PETinterim during the second week of CRT and PETpost at 3 months post CRT. If the PETpost at 3 months post-treatment FDG-PET reveals a partial response, and the patient does not have clinically progressive disease, a 4th FDG-PET (PETprogress) will be performed at 5 months after completion of CRT. The scans will be performed in the Nuclear Medicine department at Liverpool Hospital on a digital PET scanner (GE Healthcare, Discovery MI) in 3D mode for a total acquisition time of 1.5 – 2.5 min per bed position, adjusted according to the patient weight, from mid brain to proximal femora at about 1 hour post injection of a radiotracer called fluorodeoxyglucose (3.4 MBq/Kg). PET images will be reconstructed using GE VUE Point FX (Time of Flight) algorithm into a 256 x 256 matrix size with a slice thickness of 3.75 to 4.0 mm, and GE Q.Clear iterative reconstruction and if required Q-static motion-corrected respiratory gated algorithm for measurement of SUV and other volumetric parameters. Transmission scans and attenuation corrections will be obtained by using a 128-slice CT, using helical mode without the use of a contrast medium. CT images are to be acquired at 3.75 to 5mm slice thickness and reconstructed to a transaxial matrix size of 512 x 512. The current (30-40 mAs) and voltage (120-140 kV) are varied according to the patient weight. All FDG PET images will be analysed by the consensus reading of a nuclear medicine physician and a radiation oncologist. < Primary outcome(s): Locoregional failure will be assessed by using FDG PET, MRI imaging and HPV ctDNA biomarker testing.[ 6 months post chemoradiation treatment];MTV 2.5 will be assessed using FDG-PET imaging.[ 2 weeks during chemoradiation treatment, 3 and 6 months post chemoradiation treatment];Diffusion weighted images with B values 50, 400 and 800 will be assessed using MRI[ 2 weeks during Chemoradiation treatment] Study Design: Purpose: Diagnosis; Allocation: Non-randomised trial; Masking: Open (masking not used);Assignment: Single group;Type of endpoint: Efficacy

Dataset Information

Single-center Ambispective Observational Study on the Role of Magnetic Resonance Imaging (MRI) in the Evaluation of Patient Affected by Hepatic Metastases of Carcinoma of the Colorectal Cancer (CRC).

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