Hepato Cellular CarcinomaNCT07704216
Peritumoral MRE Stiffness for Predicting Resection Margin Status and Recurrence in Liver Cancer
An observational study of Hepato Cellular Carcinoma and Intrahepatic Bile Duct Carcinoma, run by Second Affiliated Hospital of Xi'an Jiaotong University.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hepato Cellular Carcinoma, Intrahepatic Bile Duct Carcinoma, Metastatic Hepatocellular Carcinoma
- What is being tested?
- Three-Dimensional Magnetic Resonance Elastography
- Type of treatment
- Medical device
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2026to 1 Oct 2031
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
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- Prior history of liver resection or liver transplantation
- Pregnant or breastfeeding women
- Anticipated poor compliance with postoperative MRE examination or follow-up
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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
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
- Being tested
- Three-Dimensional Magnetic Resonance Elastography
- Medical subject headings
- Cholangiocarcinoma, Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Three-Dimensional Magnetic Resonance ElastographyDevice
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Postoperative day 7-14
Secondary outcomes (4)
Recurrence-Free Survival (RFS)
Time from surgery to radiologically or pathologically confirmed tumor recurrence, or last follow-up if no recurrence occurs
Measured: Up to 2 years after surgery
Overall Survival (OS)
Time from surgery to death from any cause
Measured: Up to 2 years after surgery
Correlation between 3D-MRE parameters at the resection margin and time to recurrence
Association between quantitative 3D-MRE parameters (e.g., stiffness, damping ratio) measured at postoperative day 7-14 and subsequent time to tumor recurrence
Measured: Postoperative day 7-14 (MRE); up to 2 years (recurrence follow-up)
Recurrence pattern (local vs. distant intrahepatic vs. extrahepatic)
Classification of recurrence site and pattern based on imaging follow-up
Measured: Up to 2 years after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2026
- Study start1 Aug 2026 (estimated)
- Primary completion1 Oct 2029 (estimated)
- Study completion1 Oct 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepato Cellular CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Second Affiliated Hospital of Xi'an Jiaotong University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07704216
- Sponsor's protocol ID
- XJTUSAH-MRE-002
- Status last verified
- Jul 2026
- First submitted
- 10 Jul 2026
- Last updated
- 15 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07704216
- Acronym / sponsor ID
- XJTUSAH-MRE-002
- Conditions
- Hepato Cellular Carcinoma, Intrahepatic Bile Duct Carcinoma, Metastatic Hepatocellular Carcinoma
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital of Xi'an Jiaotong UniversityUniversity, hospital or other
- Study start
- 1 Aug 2026 (estimated)
- Primary completion
- 1 Oct 2029 (estimated)
- Study completion
- 1 Oct 2031 (estimated)
- First posted
- 15 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (9 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Three-Dimensional Magnetic Resonance ElastographyPatients 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. | Device | – |
Primary outcome
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.
4 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepato Cellular Carcinoma and Intrahepatic Bile Duct Carcinoma, run by Second Affiliated Hospital of Xi'an Jiaotong University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 15 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kai Qu (+8613609117104, qukai001@xjtu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic performance of postoperative 3D-MRE for detecting residual tumor at the resection margin (time frame: Postoperative day 7-14). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2026.