MRE for Assessment of Histopathological Growth Patterns in Colorectal Liver Metastases

January 6, 2024 updated by: Yu Shi, Shengjing Hospital

Noninvasive Evaluation in Diagnosis and Treatment of Histopathological Growth Patterns in Colorectal Liver Metastases Using MR Elastography-based Shear Strain Mapping

The goal of this study is to investigate the value of MR elastography-based SII as a means of detecting HGP noninvasively in patients with pathology-proven CRLM. MRE will provide a direct measure of tumor-liver adhesion to investigate the relationship between imaging findings and pathophysiological changes in the Liver.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Colorectal cancer ranks third in terms of incidence and second in terms of mortality among all cancers on the global cancer burden, based on the GLOBOCAN 2020 estimates. Among people diagnosed with colorectal cancer, 20% have metastatis, and 40% present with recurrence after previously treated localized disease. Liver is the most common site of metastasis besides lymph nodes, with a 5-year survival rate of less than 20%. Histopathological growth patterns (HGPs) appear at the interface between the tumour border and surrounding liver parenchyma which can be identified by light microscopy on tissue sections. Three primary HGPs have been identified: desmoplastic HGP (dHGP), replacement HGP and the pushing HGP. In the dHGP, the cancer cells are separated from the liver by a capsule of desmoplastic stroma in which new blood vessels are formed by sprouting angiogenesis. Recently, it has been reported that dHGP is linked to a better outcome in terms of survival and more clinical benefit achieved with preoperative anti-angiogenic therapy in patients with colorectal cancer liver metastasis (CRLM). Thus, planning of preoperative treatment might greatly benefit from HGP prediction. Preoperative prediction of HGP is challenging, however, as HGP is a histopathologic finding that can be diagnosed only with a postoperative surgical specimen. Previous studies have made many efforts to identify HGP through radiologic features (e.g., tumor margin, perilesional rim enhancement, or fused radiomics signature) by CT or MRI. However, high variability was observed in the assessment of these imaging characteristics, and they did not provide a direct measure of tumor-liver adhesion, leading to controversy in clinical practice. Recently, an MRE-based technique, termed "slip interface imaging" (SII), has been used to quantify the degree of tumor-peritumoral tissue adhesion in brain tumors and microvascular invasion in hepatocellular carcinoma noninvasively, may have the potential to characterize the mechanical characteristics of the tumor-liver interface and predict HGP of CRLM.

Study Type

Observational

Enrollment (Estimated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Liaoning
      • Shenyang, Liaoning, China, 110004
        • Recruiting
        • Shengjing Hospital of China Medical University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

Study subject inclusion criteria were adult patients with CRLM.

Description

Inclusion Criteria:

  • Diagnosed CRLM
  • Pathologic results obtained in surgical patients
  • No contraindications for magnetic resonance imaging examination

Exclusion Criteria:

  • Image quality does not meet the measurement requirements.
  • the diameter of CRLM <1cm
  • Combined with other important organ dysfunction
  • Combined with malignant tumor
  • Patients who do not sign an informed consent
  • Patients with metallic implants or foreign bodies in their bodies (pacemakers, artificial metallic heart valves, metal joints, metal implants, and those who cannot remove dentures, insulin pumps, or contraceptive rings)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Experimental: Diagnostic (MRE)
Patients undergo a preoperative routine MRI scan and MRE the day before their scheduled surgery to assess OSS and NOSS. After surgery, the HGP of tumor will be assessed by H&E-stained sections.
Diagnostic test: Magnetic Resonance Elastography and routine MRI
Assessed boundary conditions through MRE-base SII before surgery and recorded HGP of tumor after surgery.
Other Names:
  • MRE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Radiological assessment of CRLM
Time Frame: Baseline to 6 weeks
Examinations were performed on a 3.0T MRI. Mechanical vibration frequencies of 30 and 60 Hz were applied in synchrony with the MRE pulse sequence. Regions of interest (ROIs) were placed manually in the liver. The performance of the use of SII to predict HGP of tumor was evaluated with the Wilcoxon rank sum, 1-way ANOVA, and Tukey-Kramer tests.
Baseline to 6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shengjing Hospital

Investigators

  • Principal Investigator: Yu Shi, M.D., Shengjing Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 24, 2023

Primary Completion (Estimated)

December 24, 2024

Study Completion (Estimated)

December 24, 2025

Study Registration Dates

First Submitted

January 6, 2024

First Submitted That Met QC Criteria

January 6, 2024

First Posted (Actual)

January 17, 2024

Study Record Updates

Last Update Posted (Actual)

January 17, 2024

Last Update Submitted That Met QC Criteria

January 6, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ShengjingH-CRLM2023

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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