Peritumoral MRE Stiffness for Predicting Resection Margin Status and Recurrence in Liver Cancer

NCT07704216 | Not Yet Recruiting

• 1 other identifier: XJTUSAH-MRE-002
• Study Type: observational
• Target: 150
• Locations: 0 countries
• Sites: N/A

Brief Summary

Microscopic residual tumor at the resection margin is a critical risk factor for recurrence in patients undergoing hepatectomy for liver cancer, yet current detection relies solely on postoperative pathological examination of the resected specimen, which reflects only the removed tissue rather than the actual remnant liver in the patient. How to non-invasively detect residual tumor at the resection margin of the remnant liver after surgery remains an important unresolved problem in the surgical management of liver cancer. We hypothesize that tissue stiffness at the resection margin of the remnant liver, measured by postoperative three-dimensional magnetic resonance elastography (3D-MRE), may reflect microscopic residual tumor and may therefore correlate with pathological resection margin status and be predictive of postoperative tumor recurrence. This study aims to prospectively evaluate the diagnostic performance of postoperative 3D-MRE in detecting residual tumor at the resection margin, using pathological resection margin status as the reference standard, and to further assess its value in predicting tumor recurrence in patients undergoing hepatectomy for liver cancer.

Conditions

Hepato Cellular Carcinoma; Intrahepatic Bile Duct Carcinoma; Metastatic Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (1)

• Diagnostic performance of postoperative 3D-MRE for detecting residual tumor at the resection margin

  Sensitivity, specificity, and area under the receiver operating characteristic curve (AUC) of 3D-MRE-derived stiffness parameters at the resection margin of the remnant liver, compared with pathological resection margin status (R0 vs. R1) of the surgical specimen as the reference standard.

  Postoperative day 7-14

Secondary Outcomes (4)

• Recurrence-Free Survival (RFS)

  Up to 2 years after surgery

• Overall Survival (OS)

  Up to 2 years after surgery

• Correlation between 3D-MRE parameters at the resection margin and time to recurrence

  Postoperative day 7-14 (MRE); up to 2 years (recurrence follow-up)

• Recurrence pattern (local vs. distant intrahepatic vs. extrahepatic)

  Up to 2 years after surgery

Interventions

Three-Dimensional Magnetic Resonance Elastography DEVICE

Patients undergoing hepatectomy for liver cancer will undergo a postoperative three-dimensional magnetic resonance elastography (3D-MRE) examination of the remnant liver in addition to standard-of-care postoperative evaluation. 3D-MRE will be used to measure tissue stiffness and viscoelastic parameters at the resection margin of the remnant liver. These imaging findings will be compared with the pathological resection margin status (R0/R1) of the surgical specimen, which serves as the reference standard, to evaluate the diagnostic performance of 3D-MRE in detecting residual tumor at the resection margin. Patients will subsequently be followed to assess the association between 3D-MRE findings and postoperative tumor recurrence. The examination does not alter the standard postoperative management or treatment decisions.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This study will enroll adult patients with primary or metastatic liver cancer, including hepatocellular carcinoma, intrahepatic cholangiocarcinoma, or liver metastases (e.g., from colorectal cancer), who undergo curative-intent hepatectomy at the Second Affiliated Hospital of Xi'an Jiaotong University. Eligible patients will undergo postoperative 3D-MRE examination of the remnant liver and be followed to assess pathological resection margin status and subsequent tumor recurrence. Patients will be consecutively recruited from the hepatobiliary surgery department of the study center.

You may qualify if:

• Age 18-80 years
• Pathologically confirmed diagnosis of hepatocellular carcinoma, intrahepatic cholangiocarcinoma, or liver metastasis (e.g., from colorectal cancer)
• Underwent curative-intent hepatectomy with available postoperative pathological resection margin assessment
• Child-Pugh class A or B liver function (for patients with primary liver cancer)
• Able to undergo 3D-MRE examination at postoperative day 7-14
• Provision of signed and dated informed consent

You may not qualify if:

• Contraindication to MRI (e.g., non-MRI-compatible implants, severe claustrophobia)
• Palliative or non-curative surgery (R2 resection)
• Presence of unresectable extrahepatic disease at the time of surgery
• Reoperation or unplanned return to surgery within 14 days after the initial hepatectomy
• Severe postoperative complications precluding MRI examination at postoperative day 7-14 (e.g., unstable vital signs, need for intensive care)
• Death within 14 days after surgery from non-tumor-related causes
• Prior history of liver resection or liver transplantation
• Pregnant or breastfeeding women
• Anticipated poor compliance with postoperative MRE examination or follow-up

Sponsors & Collaborators

• Second Affiliated Hospital of Xi'an Jiaotong University: lead

MeSH Terms

Conditions

Cholangiocarcinoma; Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Central Study Contacts

Kai Qu

CONTACT

+8613609117104; qukai001@xjtu.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 10, 2026
• First Posted: July 15, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): October 1, 2029
• Study Completion (Estimated): October 1, 2031
• Last Updated: July 15, 2026

Record last verified: 2026-07