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Clinical Trials/NCT06208397
NCT06208397
Recruiting
Not Applicable

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

Shengjing Hospital1 site in 1 country50 target enrollmentDecember 24, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Metastatic Colorectal Cancer
Sponsor
Shengjing Hospital
Enrollment
50
Locations
1
Primary Endpoint
Radiological assessment of CRLM
Status
Recruiting
Last Updated
11 months ago

Overview

Brief Summary

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.

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.

Registry
clinicaltrials.gov
Start Date
December 24, 2023
End Date
December 24, 2026
Last Updated
11 months ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Yu Shi

Deputy director of department of radiology

Shengjing Hospital

Eligibility Criteria

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)

Outcomes

Primary Outcomes

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.

Study Sites (1)

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