NCT05059717

An Investigational Scan (MR DENSE) in Detecting Early Chemotherapy-Related Liver Injury Before Surgery in Patients With Resectable Colorectal Liver Metastases

Imaging Tissue Motion Using MR Displacement Encoding With Stimulated Echo (DENSE): Detection of Early Chemotherapy Related Liver Injury Prior to Resection of Colorectal Liver Metastases

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This trial studies how well a magnetic resonance imaging technique called Displacement Encoding with Stimulated Echo (DENSE) works in detecting chemotherapy-related liver injury in patients with colorectal cancer that has spread to the liver and can be removed by surgery. Researchers want to learn if the DENSE technique improves the standard MRI method.

Detailed description

PRIMARY OBJECTIVE: I. This is an exploratory study to collect Magnetic Resonance Displacement Encoding with Stimulated Echo (MR DENSE) imaging data of patients treated with chemotherapy prior to resection of metastases to explore its utility in detecting sinusoidal liver injury. SECONDARY OBJECTIVES: I. Estimate sensitivity of MR DENSE (determine degree of 2 dimensional \[2D\] vector displacement with cardiac cycle and variability of measurements with cardiac ventricle contraction). II. Determine detection of sinusoidal injury (sinusoidal fibrosis, necrosis of pericentral hepatocytes, narrowing and fibrosis of central veins) on biopsy with non-alignment of 2D point vectors (horizontal and vertical direction) from neighboring/immediate adjacent points on MR DENSE imaging. III. Determine correlation of intra-operative surgical scores (liver color and texture) with non-alignment of 2D point vectors (horizontal and vertical direction) from neighboring/immediate adjacent points on MR DENSE imaging. OUTLINE: Patients undergo standard of care magnetic resonance imaging (MRI) and then undergo an MRI of the liver using MR DENSE imaging sequences over 60-90 minutes. Healthy volunteers undergo MRI of the liver using DENSE imaging sequences.

Conditions

• Colorectal Carcinoma Metastatic in the Liver

Interventions

Type	Name	Description
PROCEDURE	Magnetic Resonance Imaging	Undergo standard of care MRI
PROCEDURE	Magnetic Resonance Imaging	Undergo MR DENSE imaging

Timeline

• Start date: 2018-07-12
• Primary completion: 2022-06-24
• Completion: 2022-06-24
• First posted: 2021-09-28
• Last updated: 2023-11-13