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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-12

Study Completion Date

2022-06-24

Brief Summary

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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.

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Detailed Description

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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

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Colorectal Carcinoma Metastatic in the Liver

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Diagnostic (standard of care MRI, MR DENSE MRI)

Patients undergo standard of care 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.

Group Type EXPERIMENTAL

Magnetic Resonance Imaging

Intervention Type PROCEDURE

Undergo standard of care MRI

Magnetic Resonance Imaging

Intervention Type PROCEDURE

Undergo MR DENSE imaging

Interventions

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Magnetic Resonance Imaging

Undergo standard of care MRI

Intervention Type PROCEDURE

Magnetic Resonance Imaging

Undergo MR DENSE imaging

Intervention Type PROCEDURE

Other Intervention Names

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Magnetic Resonance Imaging Scan Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance MR Imaging MRI MRI Scan NMR Imaging NMRI Nuclear Magnetic Resonance Imaging Magnetic Resonance Imaging Scan Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance MR Imaging MRI MRI Scan NMR Imaging NMRI Nuclear Magnetic Resonance Imaging

Eligibility Criteria

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Inclusion Criteria

* Patients treated with neoadjuvant chemotherapy and scheduled for hepatectomy, per standard of care at our institution, and meet criteria for hepatectomy.
* No contraindications to MRI (such implanted ferromagnetic or pump devices, metallic fragments in eye), as indicated on our departmental MRI screening form.
* Patient who is able to undergo informed consent.
* Men and non-pregnant women.
* Metastatic disease limited to liver.
* Metastases involving no more than 6 liver segments.
* No radiographic evidence of involvement of the hepatic artery, major bile ducts, main portal vein, celiac/para aortic lymph nodes.

Exclusion Criteria

* Contraindication to MRI.
* Inability to comply with study and/or follow-up procedures.
* Unable to provide informed consent.
* Presence of extrahepatic metastatic disease.
* Metastases involving more than 6 liver segments.
* Radiographic evidence of involvement of the hepatic artery, major bile ducts, main portal vein, celiac/para aortic lymph nodes.
* Pregnant women.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes