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NCT Number: NCT07704216

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

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.

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Key information

Conditions

Hepato Cellular Carcinoma Adenocarcinoma Carcinoma Carcinoma, Hepatocellular Cholangiocarcinoma Digestive System Diseases Digestive System Neoplasms Intrahepatic Bile Duct Carcinoma Liver Diseases Liver Neoplasms Metastatic Hepatocellular Carcinoma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

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

    Time frame: Postoperative day 7-14

    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.

Secondary outcomes

  1. Recurrence-Free Survival (RFS)

    Time frame: Up to 2 years after surgery

    Time from surgery to radiologically or pathologically confirmed tumor recurrence, or last follow-up if no recurrence occurs

  2. Overall Survival (OS)

    Time frame: Up to 2 years after surgery

    Time from surgery to death from any cause

  3. 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)

    Association between quantitative 3D-MRE parameters (e.g., stiffness, damping ratio) measured at postoperative day 7-14 and subsequent time to tumor recurrence

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

    Time frame: Up to 2 years after surgery

    Classification of recurrence site and pattern based on imaging follow-up

Study contacts

Contact information is provided by the study sponsor or research team.

Kai Qu

CONTACT

[email protected]

+8613609117104

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital of Xi'an Jiaotong University

Other

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2029
Study completion
2031
First posted
Jul 15, 2026
Registry last updated
Jul 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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