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Not yet recruiting NCT07704216

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

— Observational Hepato Cellular Carcinoma Intrahepatic Bile Duct Carcinoma Metastatic Hepatocellular Carcinoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Three-Dimensional Magnetic Resonance Elastography.
Who it may be relevant to
Registry conditions: Hepato Cellular Carcinoma, Intrahepatic Bile Duct Carcinoma, Metastatic Hepatocellular Carcinoma. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

A Prospective Study on the Association Between Peritumoral Elasticity Measured by Three-Dimensional Magnetic Resonance Elastography and Pathological Resection Margin Status and Postoperative Recurrence in Patients With Liver Cancer

Overview

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.

Interventions

  • Device Three-Dimensional Magnetic Resonance Elastography
    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

Primary outcome measures

  • Diagnostic performance of postoperative 3D-MRE for detecting residual tumor at the resection margin [Time frame: Postoperative day 7-14]
Secondary outcome measures (4)
  • Recurrence-Free Survival (RFS) [Time frame: Up to 2 years after surgery]
  • Overall Survival (OS) [Time frame: Up to 2 years after surgery]
  • Correlation between 3D-MRE parameters at the resection margin and time to recurrence [Time frame: Postoperative day 7-14 (MRE); up to 2 years (recurrence follow-up)]
  • Recurrence pattern (local vs. distant intrahepatic vs. extrahepatic) [Time frame: Up to 2 years after surgery]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07704216 · XJTUSAH-MRE-002

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗